Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide

NCT ID: NCT02426957

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-05-31

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.

Conditions

Suicide; Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Motivational Enhancement Therapy

The 60-90 minute intervention consists of the following components: establishing rapport, assessing motivation for change, enhancing motivation for change, envisioning the future, establishing goals, and completing goals, strategies, and change plan worksheets. Personalized feedback for the intervention will be derived from the assessment battery and will be provided in both written and graphic formats. In addition to the 60-90 minute MI intervention delivered to the adolescent, a 30-45 minute intervention will be conducted with the adolescent and parent(s) the following day, in which the adolescent will review the goals, strategies, and change plan worksheets with the parent(s), facilitated by the therapist.

Group Type: EXPERIMENTAL

motivational enhancement therapy

Intervention Type: BEHAVIORAL

The intervention consists of the following components: establishing rapport, assessing motivation for change, enhancing motivation for change, envisioning the future, establishing goals, and completing goals, strategies, and change plan worksheets.

Treatment As Usual

Treatment As Usual on inpatient psychiatric unit

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

motivational enhancement therapy

The intervention consists of the following components: establishing rapport, assessing motivation for change, enhancing motivation for change, envisioning the future, establishing goals, and completing goals, strategies, and change plan worksheets.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Foundation for Suicide Prevention

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kimberly H. McManama O'Brien

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly O'Brien

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

A00013929

Identifier Type: -

Identifier Source: org_study_id