- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925340
Family Check-Up for Adolescents and Siblings
Effects of the Family Check-Up on Adolescents With Alcohol-Related Events and Their Siblings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 175 adolescents, 12 to 18 years old, will be drawn from multiple sites to compare the experimental condition, The Family Check Up(FCU; Dishion & Kavanagh, 2003) to a family-based psychoeducational program.
The Family Check-Up is a selective intervention program that focuses on parents. Its goal is to provide individualized feedback to motivate parents to make improvements in their parenting practices. A unique strength of the FCU is that feedback is individualized and tailored to specific parenting skills as they typically pertain to an identified adolescent in the family. We propose to evaluate the efficacy of the FCU when applied to both an adolescent identified patient (IP) and a sibling close in age. Our rationale for including a sibling close in age derives from a strong empirical base which has shown that: 1) sibling resemblance for alcohol use is high and environmental factors shared by siblings account for substantial portions of variance in adolescent alcohol use; and 2) specific interactional dynamics of the sibling relationship (collusion) are related to teen alcohol use. Dr. Dishion has found that in high-risk families, sibling collusion accounts for variance in problem behavior after controlling for involvement with deviant peers. This connection between ineffective parenting strategies and sibling relationship dynamics in combination creates increased risk for alcohol use by siblings close in age. This notion serves as a foundation to examine the efficacy of a sibling-enhanced FCU intervention with respect to: 1) improvement in parental communication and monitoring; 2) reduction of sibling interactive behaviors that are associated with alcohol use; and 3) reduction of alcohol use in IP adolescents as well as siblings who are currently using alcohol. We will test specified mediators of FCU efficacy in reducing levels of alcohol use at both the parenting level and at the level of sibling dynamics. In order to determine whether other types of family-based interventions might be just as helpful as the more intensive FCU, efficacy of the sibling-enhanced FCU will be compared to a parenting psychoeducational program.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Rhode Island
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Providence, Rhode Island, United States, 02906
- Brown University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants will be 12 to 18 years old, inclusive, living at home with at least one parent or guardian.
- Participants will have a teenage sibling within 3 years of age of the identified adolescent patient. Siblings can be either biological or unrelated siblings in blended families, as long as they live in the same home as the parents targeted in the intervention conditions. The adolescent must have experienced a recent (within 1 month) alcohol-related event (ED admission, school disciplinary action, grounding by parents, legal action). The adolescent must also screen in by reaching the clinical cutoff score on the Adolescent Drinking Index.
Exclusion Criteria:
- Alcohol positive adolescents with substance dependence diagnosis requiring a higher level of care; 18 year olds living on their own.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 - Family Check Up
Brief family intervention that employs Motivational Interviewing.
|
The Family Check-Up provides a thorough assessment of individual family strengths and weaknesses and utilizes principles of motivational interviewing to encourage families to change.
|
|
Active Comparator: 2 - Psychoeducation
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Psychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teen and sibling alcohol use
Time Frame: 3 months
|
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)
|
3 months
|
|
Teen and sibling alcohol use
Time Frame: 6 months
|
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
|
6 months
|
|
Teen and sibling alcohol use
Time Frame: 12 months
|
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teen and sibling marijuana use
Time Frame: 3 months
|
Days of marijuana use in prior 3 months
|
3 months
|
|
Teen and sibling marijuana use
Time Frame: 6 months
|
Days of use in prior 3 months
|
6 months
|
|
Teen and siblings marijuana use
Time Frame: 12 months
|
Days of use in prior 3 months
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA-Spirito-AA017659
- R01AA017659 (U.S. NIH Grant/Contract)
- NIH Grant 1R01 AA017659-01
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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