Adolescent Family-Based Alcohol Prevention

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00858065
Study type	Interventional
Source	Pacific Institute for Research and Evaluation
Contact
Status	Completed
Phase	N/A
Start date	April 2005
Completion date	July 2011

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.