Sexual BehaviorNCT03655951
Birds and Bees Research Study
A study testing Web-based resource on adolescent sexual health and Alternate web-based resource on adolescent sexual health in people with Sexual Behavior and Communication, run by Innovation Research & Training at 1 site in United States.
Trial summary
The goal of this efficacy study is to evaluate how different web-based resources affect parents' and children's sexual health knowledge; attitudes, efficacy, intentions, and behaviors about parent-adolescent communication; attitudes about media messages; and media message deconstruction skills. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Communication
- What is being tested?
- Web-based resource on adolescent sexual health and Alternate web-based resource on adolescent sexual health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- parent or legal guardian of a child in 7th, 8th, or 9th grade
Who cannot join
- not fluent in English
- does not have access to internet to complete study tasks
Trial locations and contacts
1 site in 1 country.
United States1 site
innovation Research & Training
Durham, North Carolina, 27707
About this study
Official title: Parent-Teen Communication to Resist Unhealthy Media Messages
The goal of this efficacy study is to evaluate how different web-based resources affect parents' and children's sexual health knowledge; attitudes, efficacy, intentions, and behaviors about parent-adolescent communication; attitudes about media messages; and media message deconstruction skills. Parent consumer satisfaction with the resources will also be assessed.
Read the detailed description
While the majority of the students will receive sexual education at least once between seventh and twelfth grade, the content that they will receive varies greatly. Thus, adolescents turn to other sources for information about sex including their parents and the media. However, many parents face challenges in being prepared to discuss sex with their adolescent child. While over eighty percent of parents are talking with their children ages 10-18 about issues related to sex, far fewer (60%) discuss more difficult sexual topics such as birth control. These findings suggest that there is a need for evidence-based resources that teach parents the skills needed to have effective conversations with their adolescent children about sexual health topics and media messages that promote early and risky sex.
- Conditions
- Sexual Behavior, Communication
- Being tested
- Web-based resource on adolescent sexual health, Alternate web-based resource on adolescent sexual health
- Medical subject headings
- Sexual Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based resource on adolescent sexual healthBehavioural
Web-based resource on adolescent sexual health than the intervention.
Alternate web-based resource on adolescent sexual healthBehavioural
This is a different web-based resource on adolescent sexual health than the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Resource 1 | Experimental | Web-based resource on adolescent sexual health Receives: Behavioral: Web-based resource on adolescent sexual health |
| Resource 2 | Active comparator | Alternate web-based resource on adolescent sexual health Receives: Behavioral: Alternate web-based resource on adolescent sexual health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest
Parent questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest
Child questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Follow-up
Parent questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 3) follow-up questionnaire - 24 weeks after pretest
Change in Child Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Follow-up.
Child questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Secondary outcomes (74)
Change in Parental Perceived Importance of Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest
Parent questionnaire asks participants to report on a 4-point scale (1 =not at all important - 4=very important) how important they think it is to engage in parent-child communication about several relationship and sexual health topics (e.g., reasons to wait to have sex). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Level of Comfort With Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest
Parent questionnaire asks participants to report on a 4-point scale (1=not at all comfortable - 4=very comfortable) how comfortable they are engaging in parent-child communication about several relationship and sexual health topics (e.g., reasons to wait to have sex). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Reservations About Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest
Parent questionnaire asks participants to report on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about communicating with their child about sex (e.g., It would embarrass me to talk about sex and birth control with my child). Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Outcome Expectancies Related to Communicating With Their Child About Relationship and Sexual Health From Pretest to Posttest
Parent questionnaire asks participants to report on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about the outcomes of communicating with their child about sex (e.g., I will feel proud). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Self-efficacy to Engage in Communication With Their Child About Relationship and Sexual Health From Pretest to Posttest
Parent questionnaire asks participants to report on a 7-point scale (1=not sure at all - 7=completely sure) how sure they are that they can explain to their child about several relationship and sexual health topics (e.g., how pregnancy happens). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Reported Parent-child Communication Quality From Pretest to Posttest
Parent questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to parent-child communication (e.g., My child and I can talk about almost anything.) Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Reported Parent-child Communication Quality From Pretest to Posttest
Child questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to parent-child communication (e.g., My parent and I can talk about almost anything.) Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Skepticism of Media Messages From Pretest to Posttest
Parent questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Skepticism of Media Messages From Pretest to Posttest
Child questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Perceived Realism of Media Messages From Pretest to Posttest
Parent questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Perceived Realism of Media Messages From Pretest to Posttest
Child questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Sexual Media Exposure From Pretest to Posttest
Child questionnaire asks participants to report on a 4-point scale (1=Never - 4=Often) how frequently they consume various media (e.g., Think about your average week. How often do you watch television shows?), and the sexual content of the media they consume (e.g., How would you rate the amount of sexual content in the television shows you watch? No sexual content, A little sexual content, Some sexual content, A lot of sexual content). Lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Risky Online Behaviors From Pretest to Posttest
Child questionnaire asks participants to indicate on a 5-point scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always) how often they have experienced several online situations (e.g., been exposed to sexual content online). Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Intentions to Engage in Sexual Activity From Pretest to Posttest
The child questionnaire asks participants to report on a 4-point scale how likely it is that they will engage in sexual activity (e.g., How likely is it that you will have sex in the next year?) (1=Not likely at all, 2=Unlikely, 3=Likely, 4=Very likely) Participant's responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Willingness to Engage in Unwanted Sexual Activity From Pretest to Posttest
The child questionnaire asks participants to report on a 4-point scale (1=Very unwilling - 4=Very willing) their willingness to engage in sexual activity if they were not sure that they wanted to. Lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Report of Parental Evaluative Media Mediation From Pretest to Posttest
Parent questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in evaluative media mediation related to media use and rules. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Report of Parental Evaluative Media Mediation From Pretest to Posttest
Child questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in several evaluative mediation behaviors related to media use and rules.Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Child Attitudes About Teen Sex From Pretest to Posttest
Child questionnaire asks participants to indicate on a 4-point scale (1=strongly disagree - 4=Strongly agree) how much they agree with several statements about teen sex. Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Sexual Abstinence Self-efficacy Form Pretest to Posttest
Child questionnaire asks participants to indicate on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to abstaining from sexual activity. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Contraception Self-efficacy From Pretest to Posttest
Child questionnaire asks participants to indicate on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to contraception. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Supportive Parenting - Child Report From Pretest to Posttest
Child questionnaire asks participants to indicate on a 4-point scale (1=Never - 4=Always) how much they agree with several statements related to how often their parent engages in certain behaviors (e.g., How often does your parent let you know they care about you?). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Supportive Parenting - Parent Report From Pretest to Posttest
Parent questionnaire asks participants to indicate on a 4-point scale (1=Never - 4=Always) how much they agree with several statements related to how often they engage in certain behaviors (e.g., How often do you let your child know you care about them?). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest;
Change in Parents Perceived Role in Child's Sexual Health Education From Pretest to Posttest
The parent questionnaire asks, "I feel that someone else would do a better job teaching my child about sex and relationships." Parents respond to this question on a 4-point scale [Strongly disagree - Strongly agree]. Lower scores indicate more disagreement with the statement.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Frequency of Parent-child Sexual Health Discussions - Parent Report From Pretest to Posttest
Parent questionnaires ask participants how frequently they engage in parent-child communication about sex and romantic relationships (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Frequency of Parent-child Sexual Health Discussions - Child Report From Pretest to Posttest
Child questionnaires ask participants how frequently they engage in parent-child communication about sex and relationships. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Perceived Media Message Completeness - Parent Report From Pretest to Posttest
Participant views a print advertisement and parent questionnaire asks, "How complete is the information in this advertisement?" Participants respond to this question on a 5-point scale [Incomplete-Complete]. Lower scores represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Perceived Media Message Completeness - Child Report From Pretest to Posttest
Participant views a print advertisement and child questionnaire asks, "How complete is the information in this advertisement?" Participants respond to this question on a 5-point scale [Incomplete-Complete]. Lower scores represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Report of Parental Restrictive Media Mediation From Pretest to Posttest
Parent questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in several restrictive mediation behaviors related to media use and rules. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Child Report of Parental Restrictive Media Mediation From Pretest to Posttest
Child questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in several restrictive mediation behaviors related to media use and rules. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Willingness to Engage in Unprotected Sexual Activity From Pretest to Posttest
The child questionnaire asks participants to report on a 4-point scale (1=Very unwilling - 4=Very willing) their willingness to engage in unprotected sexual activity. Lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Attitudes Toward Teen Contraception Use - Child Report From Pretest to Posttest
Child questionnaire asks participant to indicate their extent of agreement or disagreement on a 4-point scale [strongly disagree - strongly agree] with several statements about teen contraception us (e.g., condoms should always be used if a teen has sex.) Higher score indicates more favorable outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Intentions to Communicate With a Medical Professional From Pretest to Posttest
Child questionnaire asks participants to indicate "Before deciding to have sex, how likely would you be to talk to your doctor or other medical professional?" Participants indicate their likelihood on a 4-point scale [1=Not at all likely; 2=Unlikely; 3=Likely; 4=Very likely]. Higher score indicates a more favorable outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Attitudes Toward Sexual Communication - Child Report From Pretest to Posttest
Child questionnaire asks participants to indicate their level of agreement on a 4-point scale [Strongly disagree - Strongly agree] to several statements about sexual communication (e.g., Before deciding to have sex, I believe teens should talk with their partner about pregnancy.). Higher scores indicate more favorable outcome.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Perceived Parental Permissiveness Toward Teen Sex - Child Report From Pretest to Posttest
Youth reported on their perceptions of their parent's permissiveness regarding their sexual activity (five items; 4-point Likert scale; Strongly disagree to Strongly agree; α=.76). Sample items include "My parent would approve of my having sex at this time in my life." Higher values indicate that the youth believes their parent is more permissive of their sexual activity as a teen.
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Normative Beliefs About Teen Sex - Child Report From Pretest to Posttest
Youth reported on the proportion of teens they believe are engaging in sexual behavior: "What percentage of teens are having sex? [(0% (no teens) to 100% (all teens)]."
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Family Having Rules About Media Use - Parent Report From Pretest to Posttest
Parent questionnaire asked parents to report about the media rules in their family, "Does your family have rules about media use? (one item; Yes, No, Unsure).
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Awareness of Family Having Rules About Media Use - Child Report From Pretest to Posttest
Child questionnaire asked child to report about the media rules in their family, "Does your family have rules about media use? (one item; Yes, No, Unsure). Participants selected either 'Yes,' 'No,' or 'Unsure' (no and unsure were combined for analyses).
Measured: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parental Perceived Importance of Parent-child Communication About Relationship and Sexual Health From Pretest to Follow-up
Parent questionnaire asks participants to report on a 4-point scale (1 =not at all important - 4=very important) how important they think it is to engage in parent-child communication about several relationship and sexual health topics (e.g., reasons to wait to have sex). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Level of Comfort With Parent-child Communication About Relationship and Sexual Health From Pretest to Follow-up
Parent questionnaire asks participants to report on a 4-point scale (1=not at all comfortable - 4=very comfortable) how comfortable they are engaging in parent-child communication about several relationship and sexual health topics (e.g., reasons to wait to have sex). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Reservations About Parent-child Communication About Relationship and Sexual Health From Pretest to Follow-up
Parent questionnaire asks participants to report on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about communicating with their child about sex (e.g., It would embarrass me to talk about sex and birth control with my child). Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Outcome Expectancies Related to Communicating With Their Child About Relationship and Sexual Health From Pretest to Follow-up
Parent questionnaire asks participants to report on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about the outcomes of communicating with their child about sex (e.g., I will feel proud). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Self-efficacy to Engage in Communication With Their Child About Relationship and Sexual Health From Pretest to Follow-up
Parent questionnaire asks participants to report on a 7-point scale (1=not sure at all - 7=completely sure) how sure they are that they can explain to their child about several relationship and sexual health topics (e.g., how pregnancy happens). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Reported Parent-child Communication Quality From Pretest to Follow-up
Parent questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to parent-child communication (e.g., My child and I can talk about almost anything.) Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Reported Parent-child Communication Quality From Pretest to Follow-up
Child questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to parent-child communication (e.g., My parent and I can talk about almost anything.) Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Skepticism of Media Messages From Pretest to Follow-up
Parent questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Skepticism of Media Messages From Pretest to Follow-up
Child questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Perceived Realism of Media Messages From Pretest to Follow-up
Child questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Sexual Media Exposure From Pretest to Follow-up
Child questionnaire asks participants to report on a 4-point scale (1=Never - 4=Often) how frequently they consume various media (e.g., Think about your average week. How often do you watch television shows?), and the sexual content of the media they consume (e.g., How would you rate the amount of sexual content in the television shows you watch? No sexual content, A little sexual content, Some sexual content, A lot of sexual content). Lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Risky Online Behaviors From Pretest to Follow-up
Child questionnaire asks participants to indicate on a 5-point scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always) how often they have experienced several online situations (e.g., been exposed to sexual content online). Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Intentions to Engage in Sexual Activity From Pretest to Follow-up
The child questionnaire asks participants to report on a 4-point scale how likely it is that they will engage in sexual activity (e.g., How likely is it that you will have sex in the next year?) (1=Not likely at all, 2=Unlikely, 3=Likely, 4=Very likely) Participant's responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Willingness to Engage in Unwanted Sexual Activity From Pretest to Follow-up
The child questionnaire asks participants to report on a 4-point scale (1=Very unwilling - 4=Very willing) their willingness to engage in sexual activity if they were not sure that they wanted to. Lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Report of Parental Evaluative Media Mediation From Pretest to Follow-up
Parent questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in evaluative media mediation related to media use and rules. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Report of Parental Evaluative Media Mediation From Pretest to Follow-up
Child questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in several evaluative mediation behaviors related to media use and rules.Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 3) follow-up questionnaire - 24 weeks after pretest
Change in Child Attitudes About Teen Sex From Pretest to Follow-up
Child questionnaire asks participants to indicate on a 4-point scale (1=strongly disagree - 4=Strongly agree) how much they agree with several statements about teen sex. Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Sexual Abstinence Self-efficacy From Pretest to Follow-up
Child questionnaire asks participants to indicate on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to abstaining from sexual activity. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Contraception Self-efficacy From Pretest to Follow-up
Child questionnaire asks participants to indicate on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements related to contraception. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Supportive Parenting - Child Report From Pretest to Follow-up
Child questionnaire asks participants to indicate on a 4-point scale (1=Never - 4=Always) how much they agree with several statements related to how often their parent engages in certain behaviors (e.g., How often does your parent let you know they care about you?). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Supportive Parenting - Parent Report Form Pretest to Follow-up
Parent questionnaire asks participants to indicate on a 4-point scale (1=Never - 4=Always) how much they agree with several statements related to how often they engage in certain behaviors (e.g., How often do you let your child know you care about them?). Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parents Perceived Role in Child's Sexual Health Education From Pretest to Follow-up
The parent questionnaire asks, "I feel that someone else would do a better job teaching my child about sex and relationships." Parents respond to this question on a 4-point scale [Strongly disagree - Strongly agree]. Lower scores indicate more disagreement with the statement.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Frequency of Parent-child Sexual Health Discussions - Parent Report From Pretest to Follow-up
Parent questionnaires ask participants how frequently they engage in parent-child communication about sex and romantic relationships (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 3) follow-up questionnaire - 24 weeks after pretest
Change in Frequency of Parent-child Sexual Health Discussions - Child Report From Pretest to Follow-up
Child questionnaires ask participants how frequently they engage in parent-child communication about sex and relationships. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Measured: 1) pretest questionnaire; 2) ) follow-up questionnaire - 24 weeks after pretest
Change in Perceived Media Message Completeness - Parent Report From Pretest to Follow-up
Participant views a print advertisement and parent questionnaire asks, "How complete is the information in this advertisement?" Participants respond to this question on a 5-point scale [Incomplete-Complete]. Lower scores represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Perceived Media Message Completeness - Child Report From Pretest to Follow-up
Participant views a print advertisement and child questionnaire asks, "How complete is the information in this advertisement?" Participants respond to this question on a 5-point scale [Incomplete-Complete]. Lower scores represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Report of Parental Restrictive Media Mediation From Pretest to Follow-up
Parent questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in several restrictive mediation behaviors related to media use and rules. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Child Report of Parental Restrictive Media Mediation From Pretest to Follow-up
Child questionnaire asks participants to rate on a 4-point scale (1=Never - 4=Often) how frequently the parent engages in several restrictive mediation behaviors related to media use and rules. Item responses will be averaged, and higher values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Willingness to Engage in Unprotected Sexual Activity From Pretest to Follow-up
The child questionnaire asks participants to report on a 4-point scale (1=Very unwilling - 4=Very willing) their willingness to engage in unprotected sexual activity. Lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Attitudes Toward Teen Contraception Use - Child Report From Pretest to Follow-up
Child questionnaire asks participant to indicate their extent of agreement or disagreement on a 4-point scale [strongly disagree - strongly agree] with several statements about teen contraception us (e.g., condoms should always be used if a teen has sex.) Higher score indicates more favorable outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Intentions to Communicate With a Medical Professional From Pretest to Follow-up
Child questionnaire asks participants to indicate "Before deciding to have sex, how likely would you be to talk to your doctor or other medical professional?" Participants indicate their likelihood on a 4-point scale [1=Not at all likely; 2=Unlikely; 3=Likely; 4=Very likely]. Higher score indicates a more favorable outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Attitudes Toward Sexual Communication - Child Report From Pretest to Follow-up
Child questionnaire asks participants to indicate their level of agreement on a 4-point scale [Strongly disagree - Strongly agree] to several statements about sexual communication (e.g., Before deciding to have sex, I believe teens should talk with their partner about pregnancy.). Higher scores indicate more favorable outcome.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Perceived Parental Permissiveness Toward Teen Sex - Child Report From Pretest to Follow-up
Youth reported on their perceptions of their parent's permissiveness regarding their sexual activity (five items; 4-point Likert scale; Strongly disagree to Strongly agree; α=.76). Sample items include "My parent would approve of my having sex at this time in my life." Higher values indicate that the youth believes their parent is more permissive of their sexual activity as a teen.
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Normative Beliefs About Teen Sex - Child Report From Pretest to Follow-up
Youth reported on the proportion of teens they believe are engaging in sexual behavior: "What percentage of teens are having sex? [(0% (no teens) to 100% (all teens)]."
Measured: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Family Having Rules About Media Use - Parent Report From Pretest to Follow-up
Parent questionnaire asked parents to report about the media rules in their family, "Does your family have rules about media use? (one item; Yes, No, Unsure).
Measured: 1) pretest questionnaire;2) follow-up questionnaire - 24 weeks after pretest
Change in Awareness of Family Having Rules About Media Use - Child Report From Pretest to Follow-up
Child questionnaire asked child to report about the media rules in their family, "Does your family have rules about media use? (one item; Yes, No, Unsure). Participants selected either 'Yes,' 'No,' or 'Unsure' (no and unsure were combined for analyses).
Measured: 1) pretest questionnaire; 2)follow-up questionnaire - 24 weeks after pretest
Change in Parent Perceived Realism of Media Messages From Pretest to Follow-up
Parent questionnaire asks participants on a 4-point scale (1=Strongly disagree - 4=Strongly agree) how much they agree with several statements about media. Item responses will be averaged, and lower values represent a better outcome.
Measured: 1) pretest questionnaire; 2) follow-up - 24 weeks after pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 Aug 2018
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Research & Training
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655951
- Sponsor's protocol ID
- R44HD082968
- Status last verified
- Oct 2020
- First submitted
- 13 Aug 2018
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Teen Communication to Resist Unhealthy Media Messages
- ClinicalTrials.gov ID
- NCT03655951
- Acronym / sponsor ID
- R44HD082968
- Conditions
- Sexual Behavior, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 10 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this efficacy study is to evaluate how different web-based resources affect parents' and children's sexual health knowledge; attitudes, efficacy, intentions, and behaviors about parent-adolescent communication; attitudes about media messages; and media message deconstruction skills. Parent consumer satisfaction with the resources will also be assessed.
Detailed description
While the majority of the students will receive sexual education at least once between seventh and twelfth grade, the content that they will receive varies greatly. Thus, adolescents turn to other sources for information about sex including their parents and the media. However, many parents face challenges in being prepared to discuss sex with their adolescent child. While over eighty percent of parents are talking with their children ages 10-18 about issues related to sex, far fewer (60%) discuss more difficult sexual topics such as birth control. These findings suggest that there is a need for evidence-based resources that teach parents the skills needed to have effective conversations with their adolescent children about sexual health topics and media messages that promote early and risky sex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resource 1 | Experimental | Behavioral: Web-based resource on adolescent sexual healthWeb-based resource on adolescent sexual health |
| Resource 2 | Active comparator | Behavioral: Alternate web-based resource on adolescent sexual healthAlternate web-based resource on adolescent sexual health |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- parent or legal guardian of a child in 7th, 8th, or 9th grade
Key exclusion criteria (2 listed)
- not fluent in English
- does not have access to internet to complete study tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based resource on adolescent sexual healthWeb-based resource on adolescent sexual health than the intervention. | Behavioural | Resource 1 |
| Alternate web-based resource on adolescent sexual healthThis is a different web-based resource on adolescent sexual health than the intervention. | Behavioural | Resource 2 |
Primary outcome
Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Parent questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Change in Child Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Child questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Follow-up
Time frame: 1) pretest questionnaire; 3) follow-up questionnaire - 24 weeks after pretest
Parent questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
Change in Child Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Follow-up.
Time frame: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Child questionnaires ask participants how frequently they engage in parent-child communication about relationships, sex, and media. (1. Never; 2. Rarely; 3. Sometimes; 4. Often). Higher numbers represent a better outcome.
74 secondary outcomes
Change in Parental Perceived Importance of Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Level of Comfort With Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Reservations About Parent-child Communication About Relationship and Sexual Health From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Outcome Expectancies Related to Communicating With Their Child About Relationship and Sexual Health From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Self-efficacy to Engage in Communication With Their Child About Relationship and Sexual Health From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Reported Parent-child Communication Quality From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Reported Parent-child Communication Quality From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Skepticism of Media Messages From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Skepticism of Media Messages From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Perceived Realism of Media Messages From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Perceived Realism of Media Messages From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Sexual Media Exposure From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Risky Online Behaviors From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Intentions to Engage in Sexual Activity From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Willingness to Engage in Unwanted Sexual Activity From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Report of Parental Evaluative Media Mediation From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Child Report of Parental Evaluative Media Mediation From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Child Attitudes About Teen Sex From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Sexual Abstinence Self-efficacy Form Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Contraception Self-efficacy From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Supportive Parenting - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Supportive Parenting - Parent Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest;
Change in Parents Perceived Role in Child's Sexual Health Education From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Frequency of Parent-child Sexual Health Discussions - Parent Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Frequency of Parent-child Sexual Health Discussions - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Perceived Media Message Completeness - Parent Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Perceived Media Message Completeness - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parent Report of Parental Restrictive Media Mediation From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Child Report of Parental Restrictive Media Mediation From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Willingness to Engage in Unprotected Sexual Activity From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Attitudes Toward Teen Contraception Use - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Intentions to Communicate With a Medical Professional From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Attitudes Toward Sexual Communication - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Perceived Parental Permissiveness Toward Teen Sex - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Normative Beliefs About Teen Sex - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest; 3) follow-up questionnaire - 24 weeks after pretest
Change in Family Having Rules About Media Use - Parent Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Awareness of Family Having Rules About Media Use - Child Report From Pretest to Posttest
Time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest
Change in Parental Perceived Importance of Parent-child Communication About Relationship and Sexual Health From Pretest to Follow-up
Time frame: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Level of Comfort With Parent-child Communication About Relationship and Sexual Health From Pretest to Follow-up
Time frame: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Change in Parent Reservations About Parent-child Communication About Relationship and Sexual Health From Pretest to Follow-up
Time frame: 1) pretest questionnaire; 2) follow-up questionnaire - 24 weeks after pretest
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based resource on adolescent sexual health and Alternate web-based resource on adolescent sexual health in people with Sexual Behavior and Communication, run by Innovation Research & Training at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Reported Frequency of Parent-child Communication About Relationships, Sex, and Media From Pretest to Posttest (time frame: 1) pretest questionnaire; 2) posttest questionnaire - 4 weeks after pretest). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.