Parent-Child RelationsMPNCT02330666
Parent-child Communication and Health-risk Behavior
A study testing Mission Possible: Parents & Kids Who Listen in people with Parent-Child Relations, run by University of Wisconsin, Madison.
Trial summary
Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society. Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Mission Possible: Parents & Kids Who Listen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 2010
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults and youth must be English speakers
- Youth must be 10 years old
Who cannot join
- Severe mental or physical illness that could preclude involvement in data collection procedures
- Family plans to move from the metropolitan areas prior to study completion
About this study
Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society. Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been found to be protective against a youth's involvement in health-risk behaviors. To promote positive adult-youth communication, in earlier work we developed, tested, and found efficacious an intervention, Mission Possible: Parents and Kids Who Listen (MP). This study is designed to test the following hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive communication when compared with adults who did not participate; (b) Youth who participate in MP will have a lower incidence of health-risk behavior when compared with youth who did not participate; and (c) Positive adult-youth communication will mediate childhood health-risk behavior in the presence of risk processes that predict participation. The experimental design is a 2-group (intervention and comparison) pre-test repeated measures design with six waves of data collection over three years and two booster sessions of the intervention. Elementary school and community centers in Madison and Chicago served as recruitment sites for parent-child dyads.
- Conditions
- Parent-Child Relations
- Being tested
- Mission Possible: Parents & Kids Who Listen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mission Possible: Parents & Kids Who ListenBehavioural
MP is a 12-hour, 6-session, manualized skills training program with 2 boosters. Behavioral strategies teach adults and youth to communicate with one another emphasizing youth's need for flexible family boundaries, emotional closeness, and adults as resources. Dyads attend together. Sessions begin with relaxation exercises, review of the prior week's lessons and homework, and examination of success and failure in trying communication techniques. New concepts are introduced using didactic videotaped presentations. Lively, interactive, developmentally appropriate group exercises follow reflective of ethnic diversity that are reinforced with handouts and encouragement to try them at home. Week-by-week content covers: Developmental Changes; Self-Esteem; Communicating What You Want; Listening to What the Other Wants; Solving Conflicts; and Letting Go. The booster sessions are 2 hours in length and update developmental concepts; 5 basic listening skills; and 6 conflict resolution steps.
| Study group | Role | What they receive |
|---|---|---|
| Comparison | No intervention | Standard care |
| Intervention | Experimental | Communication skills training Mission Possible: Parents \& Kids Who Listen Receives: Behavioral: Mission Possible: Parents & Kids Who Listen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth Health Risk Behavior
Measured with the 22-item Children's Health Risk Behavior Scale (CHRBS). This instrument, based on the conceptual categories of the Youth Risk Behavioral Surveillance Survey, assesses potential for unintentional and intentional injury or violence, tobacco use, alcohol and other drug use, sexual curiosity, and health practices.
Measured: 3 years
Secondary outcomes (3)
Openness of Communication
The Parent Adolescent Communication Inventory (Olson, 1983) is a 20-item, 2-subscale (open or problem communication) self-report instrument with a youth version and an adult version, the difference being the target of the item - mother/father or youth. Scores are computed for adult communication, youth-mother communication, youth-father communication.
Measured: 3 years
Family Satisfaction
The Family Adaptability and Cohesion Evaluation Scale III is a 20-item, self-report instrument (Olson, 1994) to measure family satisfaction. Participants answer the items twice, first to assess current and then to assess ideal family system conditions. The difference between ideal and perceived conditions yields a family satisfaction score.
Measured: 3 years
Problem-Solving Skill
50% of the dyads were randomly selected for assessment of problem solving ability. The procedure was to (a) identify a problem for discussion from the Issues Checklist (IC), (b) videotape the dyad attempting to solve the problem identified, and (c) code the videotaped interaction using the Iowa Family Interaction Rating Scales (IFIRS). The IFIRS is a macro-level observational coding system that was initially developed in 1989 and has undergone 5 revisions. Scales used to assess three aspects of family interaction were: (a) individual behavioral characteristics or each person's generalized interaction consisting of 8 items, e.g., use of humor, mood, whining and complaining; (b) dyadic behavioral characteristics or the nature of behavior exchanged from one family member to another consisting of 22 items, e.g., hostility, warmth/support; and (c) the family problem-solving process consisting of 10 items, e.g., solution quality, family enjoyment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startAug 2004
- Primary completionFeb 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University Chicago, Iowa State University
- Responsible party
- Sponsor
- Investigators
- Susan K Riesch, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330666
- Sponsor's protocol ID
- 2003-352
- Acronym
- MP
- Status last verified
- Sep 2015
- First submitted
- 30 Dec 2014
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-child Communication and Health-risk Behavior
- ClinicalTrials.gov ID
- NCT02330666
- Acronym / sponsor ID
- MP / 2003-352
- Conditions
- Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Loyola University Chicago, Iowa State University
- Study start
- Aug 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society. Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been found to be protective against a youth's involvement in health-risk behaviors. To promote positive adult-youth communication, in earlier work we developed, tested, and found efficacious an intervention, Mission Possible: Parents and Kids Who Listen (MP). This study is designed to test the following hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive communication when compared with adults who did not participate; (b) Youth who participate in MP will have a lower incidence of health-risk behavior when compared with youth who did not participate; and (c) Positive adult-youth communication will mediate childhood health-risk behavior in the presence of risk processes that predict participation. The experimental design is a 2-group (intervention and comparison) pre-test repeated measures design with six waves of data collection over three years and two booster sessions of the intervention. Elementary school and community centers in Madison and Chicago served as recruitment sites for parent-child dyads.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison | No intervention | –Standard care |
| Intervention | Experimental | Behavioral: Mission Possible: Parents & Kids Who ListenCommunication skills training Mission Possible: Parents \& Kids Who Listen |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adults and youth must be English speakers
- Youth must be 10 years old
Key exclusion criteria (2 listed)
- Severe mental or physical illness that could preclude involvement in data collection procedures
- Family plans to move from the metropolitan areas prior to study completion
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 |
|---|---|---|
| Mission Possible: Parents & Kids Who ListenMP is a 12-hour, 6-session, manualized skills training program with 2 boosters. Behavioral strategies teach adults and youth to communicate with one another emphasizing youth's need for flexible family boundaries, emotional closeness, and adults as resources. Dyads attend together. Sessions begin with relaxation exercises, review of the prior week's lessons and homework, and examination of success and failure in trying communication techniques. New concepts are introduced using didactic videotaped presentations. Lively, interactive, developmentally appropriate group exercises follow reflective of ethnic diversity that are reinforced with handouts and encouragement to try them at home. Week-by-week content covers: Developmental Changes; Self-Esteem; Communicating What You Want; Listening to What the Other Wants; Solving Conflicts; and Letting Go. The booster sessions are 2 hours in length and update developmental concepts; 5 basic listening skills; and 6 conflict resolution steps. | Behavioural | Intervention |
Primary outcome
Youth Health Risk Behavior
Time frame: 3 years
Measured with the 22-item Children's Health Risk Behavior Scale (CHRBS). This instrument, based on the conceptual categories of the Youth Risk Behavioral Surveillance Survey, assesses potential for unintentional and intentional injury or violence, tobacco use, alcohol and other drug use, sexual curiosity, and health practices.
3 secondary outcomes
Openness of Communication
Time frame: 3 years
Family Satisfaction
Time frame: 3 years
Problem-Solving Skill
Time frame: 3 years
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 2 Oct 2015.
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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.
Susan K Riesch, PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Mission Possible: Parents & Kids Who Listen in people with Parent-Child Relations, run by University of Wisconsin, Madison.
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 2 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 2 Oct 2015. 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?
Youth Health Risk Behavior (time frame: 3 years). 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 2 Oct 2015.