Adults In The Making Prevention Trial (AIM)
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adults in the Making program
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- Residence in county where sampling was targeted
- Youth self identified as African American or Black
Exclusion Criteria:
- Unable to complete survey measures or participate in intervention due to mental health concerns
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AIM preventive intervention
Control
Arm Description
Families were assigned to receive a 6 session, 12 hour prevention program in their community.
Families were assigned to no intervention control.
Outcomes
Primary Outcome Measures
Alcohol use
Past month frequency of alcohol use, item from Monitoring the Future Survey
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
Secondary Outcome Measures
Depressive symptoms
parent reported depressed/anxious symptoms on a subscale of the Child Behavor Checklist that ranged from 0-24 with higher scores indicating more depressive or anxiety symptoms
Protective caregiving
parent reported scale assessed the extent to which the primary caregiver provided emotional support, was accessible to the youth, and discussed difficult issues with which the youth was dealing. The 15 item scale ranged from 15-60 with higher scores reflecting more protective caregiving.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04510116
Brief Title
Adults In The Making Prevention Trial
Acronym
AIM
Official Title
Preventing Alcohol Use Among African American Youths
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study investigators designed a multicomponent prevention program to deter substance use among African American emerging adults in rural Georgia (SAAF-Emerging Adult Program, SAAF-EAP). The intervention's delivery is modeled after an existing prevention program designed by Dr. Brody called, The Strong African American Families (SAAF) program and included a series of separate weekly sessions for emerging adults, their parents, and extended family members, as well as sessions in which participants interact with one another to apply the skills learned in the separate sessions. The sample consisted of 690 families with a high school senior, half of whom will be assigned randomly to a prevention group and half of whom will be assigned to a control group. Pre-intervention, post-intervention, and follow-up assessments of emerging adults' substance use were conducted with the entire sample. The study started when the participants were high school seniors, and followed them and their families as the youths enter emerging adulthood. The conceptual model that guided the program incorporated the following predictors: (1) autonomy-promoting parenting and responsive family relationships, characterized by developmentally appropriate instrumental and emotional support, expectations and discussions about emerging adults' roles and responsibilities, affectively positive relationships that feature open communication, and adaptive racial socialization that includes strategies for dealing with discrimination; (2) contextual stressors, including racial discrimination, poverty, and limitations in educational and occupational opportunities; (3) negative emotions and the avoidant coping responses they elicit; (4) emerging adults' future orientation, self-regulation, emotion regulation, racial identity, and sense of adult status; (5) affiliations with substance-using friends and romantic partners; and (6) cognitive antecedents of substance use, including prototypes of substance-using agemates and willingness to use substances in risk-conducive situations. To examine these constructs, the investigators implemented a multi-informant design that included assessments from emerging adults, their friends and romantic partners, their primary caregivers, and their extended family members.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIM preventive intervention
Arm Type
Experimental
Arm Description
Families were assigned to receive a 6 session, 12 hour prevention program in their community.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Families were assigned to no intervention control.
Intervention Type
Behavioral
Intervention Name(s)
Adults in the Making program
Other Intervention Name(s)
AIM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol use
Description
Past month frequency of alcohol use, item from Monitoring the Future Survey
Time Frame
follow up at 27 months post baseline
Title
Conduct problems
Description
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
Time Frame
follow up at 27 months post baseline
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
parent reported depressed/anxious symptoms on a subscale of the Child Behavor Checklist that ranged from 0-24 with higher scores indicating more depressive or anxiety symptoms
Time Frame
follow up at 27 months post baseline
Title
Protective caregiving
Description
parent reported scale assessed the extent to which the primary caregiver provided emotional support, was accessible to the youth, and discussed difficult issues with which the youth was dealing. The 15 item scale ranged from 15-60 with higher scores reflecting more protective caregiving.
Time Frame
follow up at 6 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Residence in county where sampling was targeted
Youth self identified as African American or Black
Exclusion Criteria:
Unable to complete survey measures or participate in intervention due to mental health concerns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene Brody, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33760092
Citation
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.
Results Reference
derived
Learn more about this trial
Adults In The Making Prevention Trial
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