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Adolescent Family-Based Alcohol Prevention

Primary Purpose

Alcohol Abuse, Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strengthening Families Program (SFP)
Family Matters
Sponsored by
Pacific Institute for Research and Evaluation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring Adolescent alcohol and other drug use, Choice, Family-based, Prevention

Eligibility Criteria

11 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Prevention Research Center
  • Kaiser Permanente Division of Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Active Comparator

Arm Label

RCT FM

Choice SFP

RCT SFP

RCT Control

Choice FM

Arm Description

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.

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).

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.

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.

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.

Outcomes

Primary Outcome Measures

Youth alcohol and other drug use

Secondary Outcome Measures

Recruitment, retention, completion

Full Information

First Posted
March 5, 2009
Last Updated
September 23, 2021
Sponsor
Pacific Institute for Research and Evaluation
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00858065
Brief Title
Adolescent Family-Based Alcohol Prevention
Official Title
Adolescent Family-Based Alcohol Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Institute for Research and Evaluation
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Drug Abuse
Keywords
Adolescent alcohol and other drug use, Choice, Family-based, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Families were assigned either to a group with no choice or with choice but were aware that they would be randomly assigned but knew which option they received.
Allocation
Randomized
Enrollment
1228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RCT FM
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Choice SFP
Arm Type
Active Comparator
Arm Description
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).
Arm Title
RCT SFP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RCT Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Choice FM
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strengthening Families Program (SFP)
Other Intervention Name(s)
SFP
Intervention Description
Prevention program with 7 weekly group sessions for parent and child.
Intervention Type
Behavioral
Intervention Name(s)
Family Matters
Other Intervention Name(s)
FM
Intervention Description
Prevention program with 4 booklets for families to do at home with their child.
Primary Outcome Measure Information:
Title
Youth alcohol and other drug use
Time Frame
1 year and 2 years
Secondary Outcome Measure Information:
Title
Recruitment, retention, completion
Time Frame
1 year and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda A. Miller, Ph.D.
Organizational Affiliation
Prevention Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Kaiser Permanente Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States

12. IPD Sharing Statement

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Adolescent Family-Based Alcohol Prevention

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