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Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents

17 mars 2022 mis à jour par: Kimberly H. McManama O'Brien, Boston Children's Hospital

The primary goal of this study is to test the acceptability and feasibility of iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), a novel adjunctive intervention for alcohol use and alcohol-related suicidal thoughts and behaviors for suicidal adolescent inpatients.

The investigators will first conduct an open trial with 10 adolescents and their parents to test iASIST and make subsequent changes to the booster. Next, the investigators will conduct a randomized trial with 50 adolescents and their parents to test the feasibility and acceptability of iASIST as well as associations with alcohol- and suicide-related outcomes at 3 months post-discharge, relative to participants who receive an attention-matched comparison condition focused on the role of a healthy lifestyle in mental health that includes a post-discharge mHealth control targeting the maintenance of a healthy lifestyle.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

The primary goal of this study is to test the acceptability and feasibility of iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), a novel adjunctive intervention for alcohol use and alcohol-related suicidal thoughts and behaviors for suicidal adolescent inpatients.

The intervention in this study, iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), involves three components: 1) an individual intervention with the adolescent in which motivational enhancement techniques are used to explore alcohol use as a risk factor for continued suicide-related thoughts and behaviors in order to build the adolescent's motivation to reduce or stop their alcohol use and to create a complementary change plan, 2) a subsequent family intervention in which the interventionist facilitates a discussion between the adolescent and parent about the change plan using motivational enhancement techniques to align the parent with the adolescent to strengthen the adolescent's self-efficacy and commitment to the change plan as well as the parent's ability to support the adolescent in their plan to reduce or stop drinking, and 3) a post-discharge mHealth booster to adolescents focused on strengthening their commitment to the change plan, and to parents focused on their commitment, confidence, and ability related to supporting the adolescent in reducing or stopping drinking. The investigators will first conduct an open trial with 10 adolescents and their parents to test iASIST and make subsequent changes to the booster. Next, the investigators will conduct a randomized trial with 50 adolescents and their parents to test the feasibility and acceptability of iASIST as well as associations with alcohol- and suicide-related outcomes at 3 months post-discharge, relative to participants who receive an attention-matched comparison condition focused on the role of a healthy lifestyle in mental health that includes a post-discharge mHealth control targeting the maintenance of a healthy lifestyle.

The investigators anticipate that adolescents who receive iASIST, relative to the comparison condition, will have increased negative alcohol expectancies, alcohol situational confidence, mental health and/or substance abuse service use, parental monitoring, parent-child communication about alcohol, and decreased frequency of alcohol use, positive alcohol expectancies, suicide ideation, plans, and attempts at 3 month follow-up. Although the investigators do not expect statistically significant differences due to the small sample size, they will calculate confidence intervals around the effect sizes. Data will be informative for designing a fully powered clinical trial.

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Boston Children's Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 17 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Must be currently hospitalized for suicide ideation or attempt
  • Must have used alcohol in past 3 months, indicated by selecting "yes" on the screening question ["Have you drank alcohol in the past 3 months?"]
  • Must be between the age of 13-17
  • The adolescent and parent/guardian must own a smartphone
  • Must have the ability to communicate in English.

Exclusion Criteria:

  • developmental delay
  • autism spectrum disorder
  • psychosis

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: iASIST
iASIST, involves 1) an individual intervention with the adolescent in which motivational enhancement techniques are used to explore alcohol use as a risk factor for continued suicide-related thoughts and behaviors and to create a change plan, 2) a subsequent family intervention using motivational enhancement techniques to align the parent with the adolescent to strengthen the adolescent's self-efficacy and commitment to the change plan as well as the parent's ability to support the adolescent in their plan to reduce or stop drinking, and 3) a post-discharge mHealth booster to adolescents focused on strengthening their commitment to the change plan, and to parents focused on their commitment, confidence, and ability related to supporting the adolescent in reducing or stopping drinking.
Integrated Alcohol and Suicide Intervention for Suicidal Teens
Comparateur actif: Attention-Matched Comparison
The attention-matched comparison condition involves one psychoeducation session focused on the role of a healthy lifestyle in mental health and an additional family intervention, in which the adolescent will review handouts from the session with the parent, facilitated by the interventionist. In addition, adolescents and parents assigned to the comparison will receive a post-discharge mHealth control about the maintenance of a healthy lifestyle with the same frequency and type of interaction as the iASIST mHealth booster.
Integrated Alcohol and Suicide Intervention for Suicidal Teens

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Alcohol Use measured by the Timeline Followback Assessment
Délai: 3 months
frequency of alcohol use
3 months
Suicide Attempts measured by the Columbia Suicide Severity Rating Scale
Délai: 3 months
quantity of suicide attempts
3 months
Suicide Ideation measured by the Suicide Ideation Questionnaire, Jr
Délai: 1 month
severity of suicide ideation
1 month
Alcohol Use measured by the Timeline Followback Assessment
Délai: 3 Months
Quantity of Alcohol Use
3 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 juin 2018

Achèvement primaire (Réel)

1 avril 2021

Achèvement de l'étude (Réel)

1 avril 2021

Dates d'inscription aux études

Première soumission

1 mai 2018

Première soumission répondant aux critères de contrôle qualité

30 juillet 2018

Première publication (Réel)

31 juillet 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 00028139

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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