Clinical trial NCT03607318: Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents
Official title: Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Suicide, Attempted
Adolescent Behavior
Keywords: alcohol
suicide
adolescents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol Use measured by the Timeline Followback Assessment
timeFrame: 3 months
measure: Suicide Attempts measured by the Columbia Suicide Severity Rating Scale
timeFrame: 3 months
measure: Suicide Ideation measured by the Suicide Ideation Questionnaire, Jr
timeFrame: 1 month
measure: Alcohol Use measured by the Timeline Followback Assessment
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: