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Family Check-Up for Adolescents and Siblings

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family Check Up
Psychoeducation
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Alcohol, Substance Abuse, Adolescent, Family functioning

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 - Family Check Up

2 - Psychoeducation

Arm Description

Brief family intervention that employs Motivational Interviewing.

Outcomes

Primary Outcome Measures

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)
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
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

Secondary Outcome Measures

Teen and sibling marijuana use
Days of marijuana use in prior 3 months
Teen and sibling marijuana use
Days of use in prior 3 months
Teen and siblings marijuana use
Days of use in prior 3 months

Full Information

First Posted
June 19, 2009
Last Updated
July 28, 2014
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00925340
Brief Title
Family Check-Up for Adolescents and Siblings
Official Title
Effects of the Family Check-Up on Adolescents With Alcohol-Related Events and Their Siblings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Alcohol, Substance Abuse, Adolescent, Family functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Family Check Up
Arm Type
Experimental
Arm Description
Brief family intervention that employs Motivational Interviewing.
Arm Title
2 - Psychoeducation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Family Check Up
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Psychoeducation regarding teen alcohol and drug use in general, along with ways parents can help their children stay safe from using alcohol or drugs.
Primary Outcome Measure Information:
Title
Teen and sibling alcohol use
Description
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion)
Time Frame
3 months
Title
Teen and sibling alcohol use
Description
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
Time Frame
6 months
Title
Teen and sibling alcohol use
Description
drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (5 or more drinks per occasion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Teen and sibling marijuana use
Description
Days of marijuana use in prior 3 months
Time Frame
3 months
Title
Teen and sibling marijuana use
Description
Days of use in prior 3 months
Time Frame
6 months
Title
Teen and siblings marijuana use
Description
Days of use in prior 3 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28259500
Citation
Spirito A, Hernandez L, Marceau K, Cancilliere MK, Barnett NP, Graves HR, Rodriguez AM, Knopik VS. Effects of a brief, parent-focused intervention for substance using adolescents and their sibling. J Subst Abuse Treat. 2017 Jun;77:156-165. doi: 10.1016/j.jsat.2017.02.002. Epub 2017 Mar 2.
Results Reference
derived

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Family Check-Up for Adolescents and Siblings

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