- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330666
Parent-child Communication and Health-risk Behavior (MP)
September 30, 2015 updated by: University of Wisconsin, Madison
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
604
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults and youth must be English speakers
- Youth must be 10 years old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Comparison
Standard care
|
|
|
Experimental: Intervention
Communication skills training Mission Possible: Parents & Kids Who Listen
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Openness of Communication
Time Frame: 3 years
|
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.
|
3 years
|
|
Family Satisfaction
Time Frame: 3 years
|
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.
|
3 years
|
|
Problem-Solving Skill
Time Frame: 3 years
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan K Riesch, PhD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 30, 2014
First Submitted That Met QC Criteria
December 31, 2014
First Posted (Estimate)
January 5, 2015
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
September 30, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 2003-352
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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