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NIAAA_1R01AA027253-01A1

Adolescent substance use prevention intervention research study in pediatric primary care
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04450966
Recrutement ouvert
Dernière modification : 2025/01/06
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Ages 14-17
* Presenting for well-visit with participating clinician
* Reports any lifetime alcohol use
* If no lifetime alcohol use, reports riding with a driver under the influence in the past 12 months
* Has own cell phone and is willing to share cell phone number before their scheduled visit
* Completes required pre-visit activity/activities before well visit

Exclusion Criteria:

* Youth in foster care
* Unable to read and communicate in English
* Unable to complete follow-ups
* Currently receiving treatment from specialty clinician(s) for a substance use concern
* Deemed by their clinician to be inappropriate for study participation due to neurodevelopmental delays or medical/emotional concerns

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Usual Care Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care. Donnée non disponible
  • Inconnu
  • Computer-facilitated screening and brief intervention Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention. Donnée non disponible
  • Inconnu
  • Usual Care
    État du recrutement
    unknown
    Computer-facilitated screening and brief intervention
    État du recrutement
    unknown
    Données à jour depuis : 6 janvier 2025

    Description de l'étude

    Résumé de l'étude

    Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and related riding/driving safety risk among adolescent patients. Our setting will be the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care research network, with \>600 U.S. primary care practices having participated in recent studies. This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling interventions among adolescents, and, if shown effective, the cSBI system could be widely disseminated via AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician members, thereby greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.

    Source : Importé depuis le centre

    Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices, where the majority of adolescents receive health care, are a promising venue for early identification and intervention through universal screening and brief counseling. However, while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening and brief intervention for adults, it found insufficient evidence to recommend it for adolescents.

    The goal of the proposed study is to address this evidence gap by testing the effectiveness of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for delivery by pediatric primary care clinicians to adolescents at well-visits. This cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based research network. PROS has demonstrated success in \>30 years of practice-based research, with \>600 practices participating in recent studies. Drawing on more than 15 years of our prior research on adolescent alcohol screening and brief counseling in primary care offices, the cSBI system was developed to provide a time-efficient and feasible way for pediatric practices to improve both the frequency and quality of alcohol screening and counseling. cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling, and 4) clinician training materials and protocol.

    In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2) improved patients' ratings of the quality of their clinician encounter; and 3) among those who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding with an impaired driver, a major safety risk associated with alcohol, by 42% among those with prior riding risk.

    A larger RCT of this approach, which employs an adequately-powered sample and tests generalizability of effects beyond New England, is needed. We will randomize \>30 pediatric primary care clinicians in \~10 practices nationwide to deliver UC or cSBI (1:1) to their eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to test cSBI's effect on adolescent patients' heavy episodic drinking, and on riding with an impaired driver/driving while impaired, during 12 months follow-up. We hypothesize that, compared to adolescent patients receiving usual care, those receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an impaired driver/driving while impaired during the study follow-up period.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 6 janvier 2025
    Données à jour depuis : 8 jan.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT04450966