Adolescent Problem BehaviorNCT05087004
Planned Parenthood Teen Council Program Study
A study testing Teen Council in people with Adolescent Problem Behavior, run by Philliber Research & Evaluation.
Trial summary
This is a randomized controlled trial (RCT) evaluation of the Teen Council program that was tested with high school students (grades 10-12) to assess whether it results in a reduction of teen pregnancy among other outcomes. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Problem Behavior
- What is being tested?
- Teen Council
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 6 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Applicants had to be:
- entering 10th, 11th, or 12th grades;
- able to attend an annual mandatory overnight retreat;
- interested in providing accurate sexual health information to peers;
- able to commit to weekly meetings;
- able to miss school occasionally for presentations (one day per month);
- responsible for budgeting their time and keeping up with their academic work.
Who cannot join
- Any interested participant who did not meet all of the inclusion criteria:
- was not entering 10th, 11th, or 12th grades;
- was not able to attend an annual mandatory overnight retreat;
- was not interested in providing accurate sexual health information to peers;
- was not able to commit to weekly meetings;
- was not able to miss school occasionally for presentations (one day per month); (6) was not responsible for budgeting their time and keeping up with their academic work.
About this study
Official title: Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky Teen Council Program Study
This is a randomized controlled trial (RCT) evaluation of the Teen Council program that was tested with high school students (grades 10-12) to assess whether it results in a reduction of teen pregnancy among other outcomes.
Read the detailed description
Over the course of five years, we expected to have approximately 800 teens (400 program and 400 control) in the study. Teens were randomly selected for the program (Teen Council) and control (no program) conditions.
Teens in both groups were surveyed in the late summer/early fall of their enrollment year and each spring thereafter. Participation in the evaluation by control teens and unenrolled program teens was recognized with a small stipend.
The pre-survey was administered during the summer retreat for incoming Teen Council members. The same survey was administered by Philliber staff for the control youth via online, telephone, or mailed surveys during the late summer/fall. The post-surveys were administered at the end of the school year. Again, the survey was administered by program facilitators for the Teen Council program group. Philliber administered the post survey for the control group providing the same options for completion (online, telephone, or mail).
To facilitate follow-up, complete contact information was collected at baseline. This included the telephone numbers, physical addresses, and email addresses of the student and telephone numbers of their parents/guardians. Also requested was contact information for two relatives or adult friends who would likely know how to contact the teen. Parents were asked on the consent form to provide permission to receive change of school information in the event that their teen transferred to a new school. Philliber reached out to unenrolled Teen Council members and control group teens by telephone, email, text messaging, and/or U.S. Mail for survey administration (via telephone, online, or hard copy).
- Conditions
- Adolescent Problem Behavior
- Being tested
- Teen Council
- Keywords
- Adolescent pregnancy prevention, Youth development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen CouncilBehavioural
Youth randomly selected for Teen Council attended weekly meetings for an entire school year to receive training on specific topics. In turn, they provided educational presentations to the community, which required that they miss school (about one day per month). The presentations Teen Council members offered in middle and high schools were most commonly on birth control methods; relationships; reproductive anatomy and physiology; sexual diversity; STDs/STIs; sexual consent; HIV/AIDS; and abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Teen Council Pogram | Experimental | Teens assigned to the intervention group received a 1-year long Teen Council Program. Receives: Behavioral: Teen Council |
| Control Group | No intervention | Teens assigned to the control group did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ever had sex
Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.
Measured: Prior to program participation (baseline)
Ever had sex
Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.
Measured: 1 year
Contraceptive use at last intercourse
Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.
Measured: Prior to program participation (baseline)
Contraceptive use at last intercourse
Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.
Measured: 1 year
Changes to contraceptive method in last year
Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.
Measured: Prior to program participation (baseline)
Changes to contraceptive method in last year
Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.
Measured: 1 year
Ever visited doctor/clinic for birth control, exam, or STI
Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.
Measured: Prior to program participation (baseline)
Ever visited doctor/clinic for birth control, exam, or STI
Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.
Measured: 1 year
Secondary outcomes (10)
Comfort with own sexuality scale
Seven-items that measured such things as comfort talking with a date about sex or birth control and having a good understanding of one's own sexual feelings and reactions (alpha = 0.7545). Each item was rated on a scale of 1 to 4, with the most desirable response being 4.
Measured: Prior to program participation (baseline)
Comfort with own sexuality scale
Seven-items that measured such things as comfort talking with a date about sex or birth control and having a good understanding of one's own sexual feelings and reactions (alpha = 0.7545). Each item was rated on a scale of 1 to 4, with the most desirable response being 4.
Measured: 1 year
Confidence in peer education skills scale
Eight-items, on a scale of 1 to 4, that measured confidence in accessing current information about sexually transmitted diseases and infections or explaining proper condom usage to peers (alpha = 0.7525).
Measured: Prior to program participation (baseline)
Confidence in peer education skills scale
Eight-items, on a scale of 1 to 4, that measured confidence in accessing current information about sexually transmitted diseases and infections or explaining proper condom usage to peers (alpha = 0.7525).
Measured: 1 year
Civic action scale
Six-item scale adapted from Flanagan et al. to measure ability to be actively engaged citizens (alpha = 0.6789). The scale, rated on a scale of 1 to 4, measured such things as the strength of their belief that they can make a difference in their communities and confidence that they can express their views in front of a group.
Measured: Prior to program participation (baseline)
Civic action scale
Six-item scale adapted from Flanagan et al. to measure ability to be actively engaged citizens (alpha = 0.6789). The scale, rated on a scale of 1 to 4, measured such things as the strength of their belief that they can make a difference in their communities and confidence that they can express their views in front of a group.
Measured: 1 year
Perspective taking scale
Seven-item sub-scale from the Interpersonal Reactivity Index measuring the ability of youth to be empathetic and understand the perspective of others (alpha = 0.7158). This 5-point subscale included items to measure attempts to understand their friends by imagining how things look from their perspective and trying to look at both sides of every question. The scale language was adapted to be more gender neutral, with permission of the author.
Measured: Prior to program participation (baseline)
Perspective taking scale
Seven-item sub-scale from the Interpersonal Reactivity Index measuring the ability of youth to be empathetic and understand the perspective of others (alpha = 0.7158). This 5-point subscale included items to measure attempts to understand their friends by imagining how things look from their perspective and trying to look at both sides of every question. The scale language was adapted to be more gender neutral, with permission of the author.
Measured: 1 year
Communication with parents
Two items about teen comfort talking with parents about sex and birth control, rated 1 to 4, with 4 indicating the highest level of comfort. These two items were examined individually. A third item measured whether youth had conversations with parents about sexuality or birth control in the past year (yes/no). A final item had teens report the number of such conversations in five unequal categories (0,1-5, 6-10, 11-15, and more than 15), then dichotomized to 10 or fewer conversations (0) and more than ten conversations (1).
Measured: Prior to program participation (baseline)
Communication with parents
Two items about teen comfort talking with parents about sex and birth control, rated 1 to 4, with 4 indicating the highest level of comfort. These two items were examined individually. A third item measured whether youth had conversations with parents about sexuality or birth control in the past year (yes/no). A final item had teens report the number of such conversations in five unequal categories (0,1-5, 6-10, 11-15, and more than 15), then dichotomized to 10 or fewer conversations (0) and more than ten conversations (1).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Jun 2014
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Problem 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
- Model description
- Participating Planned Parenthood affiliates recruited teens to their Teen Council program each study year during the spring and summer months. Interested teens completed an application and, if after review they were deemed by the program to be good candidates, they were interviewed. Active consent was obtained from the parents or guardians of all eligible youth and teen assent was also collected. Twice as many qualified applicants as spots on each Teen Council were accepted and their names were submitted to Philliber for random assignment to the program or survey-only groups.
- Masking
- None (open label)
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philliber Research & Evaluation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Brown, Philliber Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087004
- Sponsor's protocol ID
- Philliberresearch
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Full study report is available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky Teen Council Program Study
- ClinicalTrials.gov ID
- NCT05087004
- Acronym / sponsor ID
- Philliberresearch
- Conditions
- Adolescent Problem Behavior
- Keywords
- Adolescent pregnancy prevention, Youth development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Philliber Research & EvaluationUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial (RCT) evaluation of the Teen Council program that was tested with high school students (grades 10-12) to assess whether it results in a reduction of teen pregnancy among other outcomes.
Detailed description
Over the course of five years, we expected to have approximately 800 teens (400 program and 400 control) in the study. Teens were randomly selected for the program (Teen Council) and control (no program) conditions.
Teens in both groups were surveyed in the late summer/early fall of their enrollment year and each spring thereafter. Participation in the evaluation by control teens and unenrolled program teens was recognized with a small stipend.
The pre-survey was administered during the summer retreat for incoming Teen Council members. The same survey was administered by Philliber staff for the control youth via online, telephone, or mailed surveys during the late summer/fall. The post-surveys were administered at the end of the school year. Again, the survey was administered by program facilitators for the Teen Council program group. Philliber administered the post survey for the control group providing the same options for completion (online, telephone, or mail).
To facilitate follow-up, complete contact information was collected at baseline. This included the telephone numbers, physical addresses, and email addresses of the student and telephone numbers of their parents/guardians. Also requested was contact information for two relatives or adult friends who would likely know how to contact the teen. Parents were asked on the consent form to provide permission to receive change of school information in the event that their teen transferred to a new school. Philliber reached out to unenrolled Teen Council members and control group teens by telephone, email, text messaging, and/or U.S. Mail for survey administration (via telephone, online, or hard copy).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating Planned Parenthood affiliates recruited teens to their Teen Council program each study year during the spring and summer months. Interested teens completed an application and, if after review they were deemed by the program to be good candidates, they were interviewed. Active consent was obtained from the parents or guardians of all eligible youth and teen assent was also collected. Twice as many qualified applicants as spots on each Teen Council were accepted and their names were submitted to Philliber for random assignment to the program or survey-only groups.
| Arm | Type | Receives |
|---|---|---|
| Teen Council Pogram | Experimental | Behavioral: Teen CouncilTeens assigned to the intervention group received a 1-year long Teen Council Program. |
| Control Group | No intervention | –Teens assigned to the control group did not receive any intervention. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- entering 10th, 11th, or 12th grades;
- able to attend an annual mandatory overnight retreat;
- interested in providing accurate sexual health information to peers;
- able to commit to weekly meetings;
- able to miss school occasionally for presentations (one day per month);
Key exclusion criteria (6 listed)
- was not entering 10th, 11th, or 12th grades;
- was not able to attend an annual mandatory overnight retreat;
- was not interested in providing accurate sexual health information to peers;
- was not able to commit to weekly meetings;
- was not able to miss school occasionally for presentations (one day per month); (6) was not responsible for budgeting their time and keeping up with their academic work.
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 |
|---|---|---|
| Teen CouncilYouth randomly selected for Teen Council attended weekly meetings for an entire school year to receive training on specific topics. In turn, they provided educational presentations to the community, which required that they miss school (about one day per month). The presentations Teen Council members offered in middle and high schools were most commonly on birth control methods; relationships; reproductive anatomy and physiology; sexual diversity; STDs/STIs; sexual consent; HIV/AIDS; and abstinence. | Behavioural | Teen Council Pogram |
Primary outcome
Ever had sex
Time frame: Prior to program participation (baseline)
Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.
Ever had sex
Time frame: 1 year
Study participants were asked, "Have you ever had sexual intercourse?" Sexual intercourse was defined as any oral, anal, or penis-in-vagina sex. Item response choices were Yes/No.
Contraceptive use at last intercourse
Time frame: Prior to program participation (baseline)
Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.
Contraceptive use at last intercourse
Time frame: 1 year
Study participants were asked, "The last time you had sexual intercourse, which methods did you or your partner use to prevent pregnancy?" Item response options included: I have never had penis-in-vagina sexual intercourse; no method was used to prevent pregnancy; birth control pills; condoms; Depo-Provera (or any injectable birth control), Nuva Ring (or any birth control ring), Implanon (or any implant), birth control patch, or any IUD; withdrawal; some other method; and not sure. These responses were recoded to Yes/No.
Changes to contraceptive method in last year
Time frame: Prior to program participation (baseline)
Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.
Changes to contraceptive method in last year
Time frame: 1 year
Study participants were asked, "During the last year, have you made any changes in the use of protection from sexually-transmitted infections (STIs) or pregnancy? Item response categories included: I have never had sexual intercourse; I haven't had sexual intercourse in the past 12 months; no; yes. If response was yes, study participants were asked to identify their previous contraceptive method and their current contraceptive method. Contraceptive methods were coded as reliable or not reliable.
Ever visited doctor/clinic for birth control, exam, or STI
Time frame: Prior to program participation (baseline)
Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.
Ever visited doctor/clinic for birth control, exam, or STI
Time frame: 1 year
Study participants were asked, "j. Have you ever been to a doctor or to a clinic to get birth control, to have a pelvic exam, a testicular exam or to get a check up for sexually transmitted infections?" Item responses were Yes/No.
10 secondary outcomes
Comfort with own sexuality scale
Time frame: Prior to program participation (baseline)
Comfort with own sexuality scale
Time frame: 1 year
Confidence in peer education skills scale
Time frame: Prior to program participation (baseline)
Confidence in peer education skills scale
Time frame: 1 year
Civic action scale
Time frame: Prior to program participation (baseline)
Civic action scale
Time frame: 1 year
Perspective taking scale
Time frame: Prior to program participation (baseline)
Perspective taking scale
Time frame: 1 year
Communication with parents
Time frame: Prior to program participation (baseline)
Communication with parents
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No. Full study report is available upon request.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Council in people with Adolescent Problem Behavior, run by Philliber Research & Evaluation.
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 7 inclusion and 6 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ever had sex (time frame: Prior to program participation (baseline)). The study lists 8 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 21 Oct 2021.