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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
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

17 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 4, 2020
    Last Updated
    July 6, 2022
    Sponsor
    University of Georgia
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    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

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    Adults In The Making Prevention Trial

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