NCT04510116

Brief Summary

This study was a randomized prevention trial investigating the efficacy of the Adults in the Making (AIM) prevention program against a control condition. The primary outcome variable is alcohol use. The study sample were 367 African American seniors in high school and their primary caregivers. The AIM program is a 6 session (12 hour) family-centered intervention designed to deter alcohol use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
367

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

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

September 1, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

5 years

First QC Date

August 4, 2020

Last Update Submit

July 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Alcohol use

    Past month frequency of alcohol use, item from Monitoring the Future Survey

    follow up at 27 months post baseline

  • Conduct problems

    Parent reported rule breaking and aggression sub-scales of the Child Behavior Checklist. The combined subscales yield a score ranging from 0-38 with higher scores indicating more conduct problems

    follow up at 27 months post baseline

Secondary Outcomes (2)

  • Depressive symptoms

    follow up at 27 months post baseline

  • Protective caregiving

    follow up at 6 months post baseline

Study Arms (2)

AIM preventive intervention

EXPERIMENTAL

Families were assigned to receive a 6 session, 12 hour prevention program in their community.

Behavioral: Adults in the Making program

Control

NO INTERVENTION

Families were assigned to no intervention control.

Interventions

The AIM prevention program, modeled after an existing family-based skills-training intervention in a group format for rural African American preadolescents, consists of six consecutive weekly group meetings held at community facilities, with separate parent and youth skill-building curricula and a family curriculum. Each of the six meetings includes separate, concurrent training sessions for parents and youth, followed by a joint parent-youth session during which the families practice the skills they learned in their separate sessions. Concurrent and family sessions each last 1 hour. Thus, both parents and youth receive 12 hours of prevention training.

Also known as: AIM
AIM preventive intervention

Eligibility Criteria

Age17 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Residence in county where sampling was targeted
  • Youth self identified as African American or Black

You may not qualify if:

  • Unable to complete survey measures or participate in intervention due to mental health concerns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Brody GH, Yu T, Chen E, Miller GE, Barton AW, Kogan SM. Family-Centered Prevention Effects on the Association Between Racial Discrimination and Mental Health in Black Adolescents: Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Mar 1;4(3):e211964. doi: 10.1001/jamanetworkopen.2021.1964.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Gene Brody, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Regents Professor

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 12, 2020

Study Start

September 1, 2005

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share