NCT00858065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

6.3 years

First QC Date

March 5, 2009

Last Update Submit

September 23, 2021

Conditions

Alcohol AbuseDrug Abuse

Keywords

Adolescent alcohol and other drug useChoiceFamily-basedPrevention

Outcome Measures

Primary Outcomes (1)

  • Youth alcohol and other drug use

    1 year and 2 years

Secondary Outcomes (1)

  • Recruitment, retention, completion

    1 year and 2 years

Study Arms (5)

RCT FM

ACTIVE COMPARATOR

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

Choice SFP

ACTIVE COMPARATOR

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)

RCT SFP

ACTIVE COMPARATOR

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)

RCT Control

NO INTERVENTION

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.

Choice FM

ACTIVE COMPARATOR

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

Interventions

Strengthening Families Program (SFP)BEHAVIORAL

Prevention program with 7 weekly group sessions for parent and child.

Also known as: SFP
Choice SFPRCT SFP
Family MattersBEHAVIORAL

Prevention program with 4 booklets for families to do at home with their child.

Also known as: FM
Choice FMRCT FM

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prevention Research Center

Berkeley, California, 94704, United States

Location

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Brenda A. Miller, Ph.D.

    Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

April 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

US(2)