Family Check-Up for Adolescents and Siblings

Alcohol Abuse Clinical Trial

Official title:

Effects of the Family Check-Up on Adolescents With Alcohol-Related Events and Their Siblings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925340
• Other study ID #: NIAAA-Spirito-AA017659
• Secondary ID: R01AA017659NIH G
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2009
• Last updated: July 28, 2014
• Start date: September 2008
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A two group randomized design will be used to test the primary hypothesis that the experimental intervention will reduce alcohol consumption and alcohol-related negative consequences significantly more than a comparison family-based psychoeducation condition in both an identified alcohol-using adolescent (12- 18 years old) and his/her teenage sibling (the sibling can be 3 years older or younger than teen with the sibling's age between 12-21 years old). The experimental condition consists of the Family Check-up, while the comparison condition is a less intense parenting psychoeducation program. Time points will include follow-ups at 3, 6, and 12 months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

Behavioral:
• Family Check Up
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.
• Psychoeducation
Psychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Teen and sibling alcohol use	drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)	3 months	No
Primary	Teen and sibling alcohol use	drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion	6 months	No
Primary	Teen and sibling alcohol use	drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion	12 months	No
Secondary	Teen and sibling marijuana use	Days of marijuana use in prior 3 months	3 months	No
Secondary	Teen and sibling marijuana use	Days of use in prior 3 months	6 months	No
Secondary	Teen and siblings marijuana use	Days of use in prior 3 months	12 months	No