Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide

Suicide Clinical Trial

Official title:

Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426957
• Other study ID #: A00013929
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	drug use	Drug Use Questionnaire (DUQ). The DUQ assesses the number of days adolescents used substances over the past 30 days including nicotine, marijuana, cocaine, LSD, PCP, inhalants, etc. Internal consistency in one study sample was .75 (alpha = .80 when inhalants was dropped). Test/retest for mean number of days each substance was used was .83 from 3 to 6 month follow-up and .94 from 6 to 12 month follow-up.	3 months
Other	situational confidence	Brief Situational Confidence Questionnaire (BSCQ). The BSCQ is an eight item self-report instrument used to assess confidence in one's ability to resist the urge to use alcohol or other substances. Responses are provided on 10-point Likert scales (i.e., 10% increments, from 0%=not at all confident to 100%=completely confident). The Cronbach's alpha coefficient was 0.85 in one study.	3 months
Other	effects of alcohol	Comprehensive Effects of Alcohol (CEOA). The CEOA is 38 items and assesses positive and negative expected effects of alcohol and has demonstrated adequate internal consistency, temporal stability and construct validity.	3 months
Other	opinions about alcohol	Opinions About Alcohol Use (OAAU). The OAAU is a two item self-report measure assessing the importance and confidence in reducing alcohol use. In addition to baseline and 3 month follow-up, this measure will be administered post-intervention to all participants randomized to the intervention, to assess for within session changes.	3 months
Primary	alcohol use	Adolescent Drinking Questionnaire (ADQ). The ADQ is a 6 item self-report measure assessing drinking frequency (days per month), quantity (drinks per occasion), frequency of high-volume drinking (= 5 drinks per occasion), and frequency of intoxication (feeling "drunk" or "very, very high"), over the past month.; Timeline Follow-back Interview (TLFB). The TLFB is a widely-used research and clinical assessment tool with good reliability and validity for various groups of individuals with alcohol use problems. The TLFB collects alcohol and drug consumption information using a calendar format with temporal cues to assist in recall of days when alcohol and drugs were used, and can be used to simultaneously recall other behaviors, such as suicidal ideation and attempts. The TLFB will be conducted using the prior 30 days at baseline and each follow-up.	3 months
Secondary	suicidal ideation	Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS assesses the range of suicidal behavior including preparatory acts, aborted attempt and interrupted attempt, and passive and active suicidal ideation, as well as intensity of ideation. To avoid redundancies in measures, we will not administer the intensity of ideation section to the participant, as some of that construct is captured by the SIQ. At follow-up, suicidality will be assessed only since the last assessment.; Suicide Ideation Questionnaire (SIQ). The SIQ is a 30 item self-report instrument that assesses suicidal ideation in adolescents over the past month. Items are rated on a 7-point Likert scale (0=I never had this thought, to 6=almost every day). Coefficient alpha internal consistency measures for the SIQ have been reported at 0.97 as well as good construct validity.	3 months