- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04510116
Adults In The Making Prevention Trial (AIM)
6. juli 2022 oppdatert av: Gene H. Brody, University of Georgia
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
367
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år til 17 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: AIM preventive intervention
Families were assigned to receive a 6 session, 12 hour prevention program in their community.
|
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.
Andre navn:
|
Ingen inngripen: Control
Families were assigned to no intervention control.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Alcohol use
Tidsramme: follow up at 27 months post baseline
|
Past month frequency of alcohol use, item from Monitoring the Future Survey
|
follow up at 27 months post baseline
|
Conduct problems
Tidsramme: 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
|
follow up at 27 months post baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Depressive symptoms
Tidsramme: follow up at 27 months post baseline
|
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
|
follow up at 27 months post baseline
|
Protective caregiving
Tidsramme: follow up at 6 months post baseline
|
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.
|
follow up at 6 months post baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gene Brody, PhD, University of Georgia
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2005
Primær fullføring (Faktiske)
1. september 2010
Studiet fullført (Faktiske)
1. september 2010
Datoer for studieregistrering
Først innsendt
4. august 2020
Først innsendt som oppfylte QC-kriteriene
11. august 2020
Først lagt ut (Faktiske)
12. august 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2005-10106
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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