Adolescent Family-Based Alcohol Prevention

September 23, 2021 updated by: Brenda Miller, Pacific Institute for Research and Evaluation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

1228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Prevention Research Center
      • Oakland, California, United States, 94612
        • Kaiser Permanente Division of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RCT FM
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
Prevention program with 4 booklets for families to do at home with their child.
Other Names:
  • FM
Active Comparator: Choice SFP
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)
Prevention program with 7 weekly group sessions for parent and child.
Other Names:
  • SFP
Active Comparator: RCT SFP
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)
Prevention program with 7 weekly group sessions for parent and child.
Other Names:
  • SFP
No Intervention: RCT Control
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
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
Prevention program with 4 booklets for families to do at home with their child.
Other Names:
  • FM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Youth alcohol and other drug use
Time Frame: 1 year and 2 years
1 year and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Recruitment, retention, completion
Time Frame: 1 year and 2 years
1 year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Institute for Research and Evaluation

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Brenda A. Miller, Ph.D., Prevention Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA-BMiller-AA015323
  • R01AA015323 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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