NCT02426957

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

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

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

3.6 years

First QC Date

March 26, 2015

Last Update Submit

July 23, 2018

Conditions

SuicideAlcohol Drinking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • suicidal ideation

    3 months

Other Outcomes (4)

  • drug use

    3 months

  • situational confidence

    3 months

  • effects of alcohol

    3 months

  • +1 more other outcomes

Study Arms (2)

Motivational Enhancement Therapy

EXPERIMENTAL

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.

Behavioral: motivational enhancement therapy

Treatment As Usual

NO INTERVENTION

Treatment As Usual on inpatient psychiatric unit

Interventions

motivational enhancement therapyBEHAVIORAL

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.

Motivational Enhancement Therapy

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

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

SuicideAlcohol Drinking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorDrinking Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kimberly O'Brien

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 27, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

US(1)