Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents

Alcohol Drinking Clinical Trial

Official title:

Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607318
• Other study ID #: 00028139
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Alcohol Drinking
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• iASIST
Integrated Alcohol and Suicide Intervention for Suicidal Teens

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use measured by the Timeline Followback Assessment	frequency of alcohol use	3 months
Primary	Suicide Attempts measured by the Columbia Suicide Severity Rating Scale	quantity of suicide attempts	3 months
Primary	Suicide Ideation measured by the Suicide Ideation Questionnaire, Jr	severity of suicide ideation	1 month
Primary	Alcohol Use measured by the Timeline Followback Assessment	Quantity of Alcohol Use	3 Months