Alcohol DrinkingAIMNCT04510116
Adults In The Making Prevention Trial
A study testing Adults in the Making program in people with Alcohol Drinking, run by University of Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 19 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Adults in the Making program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Residence in county where sampling was targeted
- Youth self identified as African American or Black
Who cannot join
- Unable to complete survey measures or participate in intervention due to mental health concerns
About this study
Official title: Preventing Alcohol Use Among African American Youths
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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Adults in the Making program
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adults in the Making programBehavioural
Also called AIM
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.
| Study group | Role | What they receive |
|---|---|---|
| AIM preventive intervention | Experimental | Families were assigned to receive a 6 session, 12 hour prevention program in their community. Receives: Behavioral: Adults in the Making program |
| Control | No intervention | Families were assigned to no intervention control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Past month frequency of alcohol use, item from Monitoring the Future Survey
Measured: 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
Measured: follow up at 27 months post baseline
Secondary outcomes (2)
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
Measured: follow up at 27 months post baseline
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.
Measured: follow up at 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study startSep 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gene H. Brody, University of Georgia
- Investigators
- Gene Brody, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510116
- Sponsor's protocol ID
- 2005-10106
- Other IDs
- 2005
- Acronym
- AIM
- Status last verified
- Jul 2022
- First submitted
- 4 Aug 2020
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33760092
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol Use Among African American Youths
- ClinicalTrials.gov ID
- NCT04510116
- Acronym / sponsor ID
- AIM / 2005-10106
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM preventive intervention | Experimental | Behavioral: Adults in the Making programFamilies were assigned to receive a 6 session, 12 hour prevention program in their community. |
| Control | No intervention | –Families were assigned to no intervention control. |
Who may qualify
- Ages
- 17 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Residence in county where sampling was targeted
- Youth self identified as African American or Black
Key exclusion criteria (1 listed)
- Unable to complete survey measures or participate in intervention due to mental health concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adults in the Making programAlso: AIMThe 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. | Behavioural | AIM preventive intervention |
Primary outcome
Alcohol use
Time frame: follow up at 27 months post baseline
Past month frequency of alcohol use, item from Monitoring the Future Survey
Conduct problems
Time frame: follow up at 27 months post baseline
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
2 secondary outcomes
Depressive symptoms
Time frame: follow up at 27 months post baseline
Protective caregiving
Time frame: follow up at 6 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Derived from this study: PubMed 33760092Brody 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gene Brody, PhD principal investigator
University of Georgia
Questions about this trial
What is this clinical trial studying?
A study testing Adults in the Making program in people with Alcohol Drinking, run by University of Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: follow up at 27 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.