Family Check-Up for Adolescents and Siblings

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT00925340
First received: June 19, 2009
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Behavioral: Family Check Up
Behavioral: Psychoeducation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of the Family Check-Up on Adolescents With Alcohol-Related Events and Their Siblings

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Teen and sibling alcohol use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)

  • Teen and sibling alcohol use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion

  • Teen and sibling alcohol use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion


Secondary Outcome Measures:
  • Teen and sibling marijuana use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Days of marijuana use in prior 3 months

  • Teen and sibling marijuana use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Days of use in prior 3 months

  • Teen and siblings marijuana use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Days of use in prior 3 months


Enrollment: 104
Study Start Date: September 2008
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Family Check Up
Brief family intervention that employs Motivational Interviewing.
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.
Active Comparator: 2 - Psychoeducation Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00925340

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
  More Information

No publications provided

Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT00925340     History of Changes
Other Study ID Numbers: NIAAA-Spirito-AA017659, R01AA017659, NIH Grant 1R01 AA017659-01
Study First Received: June 19, 2009
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Alcohol
Substance Abuse
Adolescent
Family functioning

ClinicalTrials.gov processed this record on October 19, 2014