NCT03607318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

2.8 years

First QC Date

May 1, 2018

Last Update Submit

March 17, 2022

Conditions

Alcohol DrinkingSuicide, AttemptedAdolescent Behavior

Keywords

alcoholsuicideadolescents

Outcome Measures

Primary Outcomes (4)

  • Alcohol Use measured by the Timeline Followback Assessment

    frequency of alcohol use

    3 months

  • Suicide Attempts measured by the Columbia Suicide Severity Rating Scale

    quantity of suicide attempts

    3 months

  • Suicide Ideation measured by the Suicide Ideation Questionnaire, Jr

    severity of suicide ideation

    1 month

  • Alcohol Use measured by the Timeline Followback Assessment

    Quantity of Alcohol Use

    3 Months

Study Arms (2)

iASIST

EXPERIMENTAL

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.

Behavioral: iASIST

Attention-Matched Comparison

ACTIVE COMPARATOR

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.

Behavioral: iASIST

Interventions

iASISTBEHAVIORAL

Integrated Alcohol and Suicide Intervention for Suicidal Teens

Attention-Matched ComparisoniASIST

Eligibility Criteria

Age13 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGroups are stratified by self-identified gender
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • developmental delay
  • autism spectrum disorder
  • psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingSuicide, AttemptedAdolescent BehaviorSuicide

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSelf-Injurious BehaviorBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Psychiatry

Study Record Dates

First Submitted

May 1, 2018

First Posted

July 31, 2018

Study Start

June 18, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

US(1)