Adolescent Family-Based Alcohol Prevention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brenda Miller, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT00858065
First received: March 5, 2009
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Drug Abuse
Behavioral: Strengthening Families Program (SFP)
Behavioral: Family Matters
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adolescent Family-Based Alcohol Prevention

Further study details as provided by Pacific Institute for Research and Evaluation:

Primary Outcome Measures:
  • Youth alcohol and other drug use [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recruitment, retention, completion [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Enrollment: 1228
Study Start Date: April 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: FM

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).

  Eligibility

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858065

Locations
United States, California
Prevention Research Center
Berkeley, California, United States, 94704
Kaiser Permanente Division of Research
Oakland, California, United States, 94612
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
Investigators
Principal Investigator: Brenda A. Miller, Ph.D. Prevention Research Center
  More Information

No publications provided

Responsible Party: Brenda Miller, Senior Research Scientist, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT00858065     History of Changes
Other Study ID Numbers: NIAAA-BMiller-AA015323, R01AA015323
Study First Received: March 5, 2009
Last Updated: December 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Pacific Institute for Research and Evaluation:
Adolescent alcohol and other drug use
Choice
Family-based
Prevention

Additional relevant MeSH terms:
Substance-Related Disorders
Alcoholism
Mental Disorders
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on April 17, 2014