Clinical trial NCT02426957: Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide
Official title: Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Suicide
Alcohol Drinking
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2015-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will use a two group randomized controlled trial to compare a brief motivational interviewing (MI) intervention to TAU with 50 adolescents psychiatrically hospitalized for a suicide plan or attempt who have co-occurring alcohol use. Data will be collected via in-person interviews and self-administered questionnaires at baseline and 3 month follow-up assessments to explore outcome changes in negative alcohol expectancies, confidence in ability to handle situations where alcohol is present, likelihood of receiving alcohol treatment, frequency of alcohol use, and suicidal ideation, suicide planning, and suicide attempts for adolescents receiving the intervention relative to TAU.

Detailed description: A two group randomized controlled trial will be used to compare the brief MI intervention to TAU with 50 adolescents psychiatrically hospitalized for a suicide plan or attempt who have co-occurring alcohol use. Adolescents admitted to the unit for a suicide plan or attempt will be screened by PI O'Brien or Co-I White within 24 hours of their admission to determine if they meet criteria for alcohol use in past month by selecting 1-6 on Question #1 of the Adolescent Drinking Questionnaire (ADQ). Then Co-I White (or PI O'Brien in the event Co-I White is unavailable) will administer the Drug Use Questionnaire (DUQ), Timeline Follow-back Interview (TLFB), Brief Situational Confidence Questionnaire (BSCQ), Comprehensive Effects of Alcohol (CEOA), Opinions About Alcohol Use (OAAU), Suicide Ideation Questionnaire (SIQ), Inventory of Motivations for Suicide Attempts (IMSA), and a subset of questions from the Columbia-Suicide Severity Rating Scale (C-SSRS). Once assessment measures are completed, participants will be randomized to either the experimental condition or TAU. Randomization will be accomplished by using an urn randomization procedure used to retain random allocation while balancing relative probabilities of assignment to treatment groups. Urn randomization in contrast to simple or block randomization is dynamic; the probability of treatment assignment changes dependent on the degree of treatment imbalance throughout the course of the trial. We will randomize by 1) ADQ score (i.e., adolescents scoring \<4 which indicates drinking at least 2-3 times per week) and 2) gender. The adolescent will receive the individual MI intervention in a private room on the inpatient psychiatric unit; the family intervention will be delivered in a private room on the unit, ideally the next day. After the intervention the adolescent will complete the exit interview and Session Evaluation Form (SEF) to assess acceptability. Once a discharge date is made for the participant, PI O'Brien or Co-I White will schedule a 3 month follow-up appointments with the adolescent and guardian; the ADQ, DUQ, TLFB, BSCQ, CEOA, SIQ, IMSA, and C-SSRS will be readministered at the follow-up assessment in a private room in the visitors' area of the inpatient psychiatric unit by RA Wigglesworth, so that the clinician conducting the assessment is blind to condition.

Eligibility criteria: Inclusion Criteria:

* current hospitalization for suicide plan or attempt,
* alcohol use in past month, indicated by selecting 1-6 on Question #1 of the Adolescent Drinking Questionnaire (ADQ) which is currently given to all patients to fill out upon admission to the inpatient psychiatric unit,
* age 13-17, and 4) ability to communicate in English.

Exclusion Criteria:

* developmental delay, autism spectrum disorder, or psychosis, per chart review.

Primary outcomes:
measure: alcohol use
timeFrame: 3 months
Secondary outcomes:
measure: suicidal ideation
timeFrame: 3 months
Other outcomes:
measure: drug use
timeFrame: 3 months
measure: situational confidence
timeFrame: 3 months
measure: effects of alcohol
timeFrame: 3 months
measure: opinions about alcohol
timeFrame: 3 months
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Kimberly O'Brien
role: PRINCIPAL_INVESTIGATOR
References: