Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 5:22 PM
Study NCT ID:
NCT02426957
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004327', 'term': 'Drinking Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'drug use', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'situational confidence', 'timeFrame': '3 months', 'description': "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."}, {'measure': 'effects of alcohol', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'opinions about alcohol', 'timeFrame': '3 months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'alcohol use', 'timeFrame': '3 months', 'description': '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.\n\nTimeline 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.'}], 'secondaryOutcomes': [{'measure': 'suicidal ideation', 'timeFrame': '3 months', 'description': '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.\n\nSuicide 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Suicide', 'Alcohol Drinking']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current hospitalization for suicide plan or attempt,\n* 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,\n* age 13-17, and 4) ability to communicate in English.\n\nExclusion Criteria:\n\n* developmental delay, autism spectrum disorder, or psychosis, per chart review.'}, 'identificationModule': {'nctId': 'NCT02426957', 'briefTitle': 'Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide', 'orgStudyIdInfo': {'id': 'A00013929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Enhancement Therapy', 'description': '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.', 'interventionNames': ['Behavioral: motivational enhancement therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment As Usual', 'description': 'Treatment As Usual on inpatient psychiatric unit'}], 'interventions': [{'name': 'motivational enhancement therapy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Motivational Enhancement Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': "Kimberly O'Brien", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'American Foundation for Suicide Prevention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': "Kimberly H. McManama O'Brien", 'investigatorAffiliation': "Boston Children's Hospital"}}}}