Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT03607318
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use measured by the Timeline Followback Assessment', 'timeFrame': '3 months', 'description': 'frequency of alcohol use'}, {'measure': 'Suicide Attempts measured by the Columbia Suicide Severity Rating Scale', 'timeFrame': '3 months', 'description': 'quantity of suicide attempts'}, {'measure': 'Suicide Ideation measured by the Suicide Ideation Questionnaire, Jr', 'timeFrame': '1 month', 'description': 'severity of suicide ideation'}, {'measure': 'Alcohol Use measured by the Timeline Followback Assessment', 'timeFrame': '3 Months', 'description': 'Quantity of Alcohol Use'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol', 'suicide', 'adolescents'], 'conditions': ['Alcohol Drinking', 'Suicide, Attempted', 'Adolescent Behavior']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to test the acceptability and feasibility of iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), a novel adjunctive intervention for alcohol use and alcohol-related suicidal thoughts and behaviors for suicidal adolescent inpatients.\n\nThe investigators will first conduct an open trial with 10 adolescents and their parents to test iASIST and make subsequent changes to the booster. Next, the investigators will conduct a randomized trial with 50 adolescents and their parents to test the feasibility and acceptability of iASIST as well as associations with alcohol- and suicide-related outcomes at 3 months post-discharge, relative to participants who receive an attention-matched comparison condition focused on the role of a healthy lifestyle in mental health that includes a post-discharge mHealth control targeting the maintenance of a healthy lifestyle.', 'detailedDescription': "The primary goal of this study is to test the acceptability and feasibility of iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), a novel adjunctive intervention for alcohol use and alcohol-related suicidal thoughts and behaviors for suicidal adolescent inpatients.\n\nThe intervention in this study, iASIST (integrated Alcohol and Suicide Intervention for Suicidal Teens), involves three components: 1) an individual intervention with the adolescent in which motivational enhancement techniques are used to explore alcohol use as a risk factor for continued suicide-related thoughts and behaviors in order to build the adolescent's motivation to reduce or stop their alcohol use and to create a complementary change plan, 2) a subsequent family intervention in which the interventionist facilitates a discussion between the adolescent and parent about the change plan using motivational enhancement techniques to align the parent with the adolescent to strengthen the adolescent's self-efficacy and commitment to the change plan as well as the parent's ability to support the adolescent in their plan to reduce or stop drinking, and 3) a post-discharge mHealth booster to adolescents focused on strengthening their commitment to the change plan, and to parents focused on their commitment, confidence, and ability related to supporting the adolescent in reducing or stopping drinking. The investigators will first conduct an open trial with 10 adolescents and their parents to test iASIST and make subsequent changes to the booster. Next, the investigators will conduct a randomized trial with 50 adolescents and their parents to test the feasibility and acceptability of iASIST as well as associations with alcohol- and suicide-related outcomes at 3 months post-discharge, relative to participants who receive an attention-matched comparison condition focused on the role of a healthy lifestyle in mental health that includes a post-discharge mHealth control targeting the maintenance of a healthy lifestyle.\n\nThe investigators anticipate that adolescents who receive iASIST, relative to the comparison condition, will have increased negative alcohol expectancies, alcohol situational confidence, mental health and/or substance abuse service use, parental monitoring, parent-child communication about alcohol, and decreased frequency of alcohol use, positive alcohol expectancies, suicide ideation, plans, and attempts at 3 month follow-up. Although the investigators do not expect statistically significant differences due to the small sample size, they will calculate confidence intervals around the effect sizes. Data will be informative for designing a fully powered clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'genderBased': True, 'genderDescription': 'Groups are stratified by self-identified gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be currently hospitalized for suicide ideation or attempt\n* Must have used alcohol in past 3 months, indicated by selecting "yes" on the screening question \\["Have you drank alcohol in the past 3 months?"\\]\n* Must be between the age of 13-17\n* The adolescent and parent/guardian must own a smartphone\n* Must have the ability to communicate in English.\n\nExclusion Criteria:\n\n* developmental delay\n* autism spectrum disorder\n* psychosis'}, 'identificationModule': {'nctId': 'NCT03607318', 'briefTitle': 'Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Brief Alcohol Intervention and mHealth Booster for Suicidal Adolescents', 'orgStudyIdInfo': {'id': '00028139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iASIST', 'description': "iASIST, involves 1) an individual intervention with the adolescent in which motivational enhancement techniques are used to explore alcohol use as a risk factor for continued suicide-related thoughts and behaviors and to create a change plan, 2) a subsequent family intervention using motivational enhancement techniques to align the parent with the adolescent to strengthen the adolescent's self-efficacy and commitment to the change plan as well as the parent's ability to support the adolescent in their plan to reduce or stop drinking, and 3) a post-discharge mHealth booster to adolescents focused on strengthening their commitment to the change plan, and to parents focused on their commitment, confidence, and ability related to supporting the adolescent in reducing or stopping drinking.", 'interventionNames': ['Behavioral: iASIST']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention-Matched Comparison', 'description': 'The attention-matched comparison condition involves one psychoeducation session focused on the role of a healthy lifestyle in mental health and an additional family intervention, in which the adolescent will review handouts from the session with the parent, facilitated by the interventionist. In addition, adolescents and parents assigned to the comparison will receive a post-discharge mHealth control about the maintenance of a healthy lifestyle with the same frequency and type of interaction as the iASIST mHealth booster.', 'interventionNames': ['Behavioral: iASIST']}], 'interventions': [{'name': 'iASIST', 'type': 'BEHAVIORAL', 'description': 'Integrated Alcohol and Suicide Intervention for Suicidal Teens', 'armGroupLabels': ['Attention-Matched Comparison', 'iASIST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Psychiatry', 'investigatorFullName': "Kimberly H. McManama O'Brien", 'investigatorAffiliation': "Boston Children's Hospital"}}}}