Adolescent Family-Based Alcohol Prevention

Study Overview
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Brief Summary
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This study explores whether giving families a choice of family-based prevention programs to prevent adolescent alcohol use will make a difference in program recruitment, retention, completion, as well as adolescent outcomes. Half of the families are assigned to a traditional random control trial condition and half are assigned to a choice condition. Further, this effectiveness study is being implemented by Kaiser Permanente Health Care system, and explores the issues of implementing such programs within such settings.

Detailed Description
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This study examines the efficacy and effectiveness of two theory based, universal family prevention programs that have shown efficacy for reducing adolescent alcohol and other drug use: Family Matters (FM) (Bauman, 1996) and (Iowa) Strengthening Families Program (Spoth, 1999) when implemented with families randomly assigned to one of two different conditions: a family choice condition (two-groups--FM or SFP) and a traditional random control trial condition (three groups--FM, SFP, and control) called the assigned condition. The two conditions (choice vs. assigned) are being compared for differences in: (a) adolescent outcomes related to alcohol use and related behaviors; (b) family characteristics for those who participate; (c) family recruitment, retention and completion rates; d) costs for program implementation. The sample is drawn from families (N=614) with a child age 11 or 12 currently enrolled in Kaiser Permanente Health Care Plan (KP), in one of four medical centers in Northern California. An initial face-to-face interview was conducted (separately) with parent and adolescent prior to program delivery, and two follow-up interviews (12 and 24 months later) are being conducted over the telephone with parent and adolescent (separately). The health care system represents an important new mode for delivering adolescent alcohol use prevention programs to families. The specific aims of this project will provide a real world test of implementation issues and feasibility. Finally, the choice condition represents an innovative, realistic condition under which families make participation decisions outside of the traditional experimental study design protocols. Choosing a treatment based on personal preference may increase patient's sense of autonomy and self-efficacy for behavior change thereby improving outcomes (Williams, 1998; Clarke, 1999). Social cognitive theory and principles of self-regulation provide a connection between these psychological constructs and behavioral choices/health outcomes (Bandura, 1986; Clark & Zimmerman, 1990).

Official Title
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Adolescent Family-Based Alcohol Prevention

Conditions
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Alcohol Abuse, Drug Abuse

Intervention / Treatment
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* Behavioral: Strengthening Families Program (SFP)
* Behavioral: Family Matters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Families who were members of one of four Kaiser Permanente medical centers in Northern California (Oakland, Vallejo, San Francisco, and Walnut Creek) at the time the sample was drawn who had an 11-12 year old child. Exclusion Criteria: Child in alcohol or drug treatment, Did not speak English fluently, parents or adolescents with mental disorders which would hamper their ability to participate effectively or would cause them to be disruptive to the group process or for whom the comprehension of the reading material in Family Matters would be a problem.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RCT FM<br>Random control trial- Family Matters. Half the families were assigned to the RCT condition, in which they were assigned to one of two prevention programs or to a control group. This arm was assigned to Family Matters program. | Behavioral: Family Matters<br>* Prevention program with 4 booklets for families to do at home with their child.<br>* Other names: FM;|
| Active Comparator: Choice SFP<br>Half the families were assigned to the choice condition in which they can choose between two prevention programs. This arm chose the Strengthening Families Program (SFP). | Behavioral: Strengthening Families Program (SFP)<br>* Prevention program with 7 weekly group sessions for parent and child.<br>* Other names: SFP;|
| Active Comparator: RCT SFP<br>Random control trial- Strengthening Families Program. Half the families were assigned to the RCT condition, in which they were assigned to one of two prevention programs or to a control group. This arm was assigned to Strengthening Families Program. | Behavioral: Strengthening Families Program (SFP)<br>* Prevention program with 7 weekly group sessions for parent and child.<br>* Other names: SFP;|
| No Intervention: RCT Control<br>Random control trial- Control Group. Half the families were assigned to the RCT condition, in which they were assigned to one of two prevention programs or to a control group. This arm was assigned to the control group and received no prevention program. However, this group and all groups received an informational pamphlet about youth alcohol and other drug use. | |
| Active Comparator: Choice FM<br>Half the families were assigned to the choice condition in which they can choose between two prevention programs. This arm chose the Family Matters (FM) program. | Behavioral: Family Matters<br>* Prevention program with 4 booklets for families to do at home with their child.<br>* Other names: FM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth alcohol and other drug use |  | 1 year and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment, retention, completion |  | 1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choice, Adolescent alcohol and other drug use, Family-based, Prevention