Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 10:11 PM
Study NCT ID:
NCT03966833
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2019-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Enumerators will be masked to the treatment assignment of the participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1914}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal Depression 1a', 'timeFrame': '6 months', 'description': 'Score \\<=10 Primary Health Questionnaire 8 (0-24, higher is worse)'}, {'measure': 'Minimal Depression 1b', 'timeFrame': '12 months', 'description': 'Score \\<=10 Primary Health Questionnaire 8 (0-24, higher is worse)'}, {'measure': 'Minimal Depression 1c', 'timeFrame': '24 months', 'description': 'Score \\<=10 Primary Health Questionnaire 8 (0-24, higher is worse)'}, {'measure': 'Psychological Distress 2a', 'timeFrame': '6 months', 'description': 'Score \\>=3 on the General Health Questionnaire 12 (0-12, higher is worse)'}, {'measure': 'Psychological Distress 2b', 'timeFrame': '12 months', 'description': 'Score \\>=3 on the General Health Questionnaire 12 (0-12, higher is worse)'}, {'measure': 'Psychological Distress 2c', 'timeFrame': '24 months', 'description': 'Score \\>=3 on the General Health Questionnaire 12 (0-12, higher is worse)'}, {'measure': 'Self Esteem a', 'timeFrame': '6 months', 'description': 'score on Rosenberg self esteem (0-30, higher is better)'}, {'measure': 'Self Esteem b', 'timeFrame': '12 months', 'description': 'score on Rosenberg self esteem (0-30, higher is better)'}, {'measure': 'Self Esteem c', 'timeFrame': '24 months', 'description': 'score on Rosenberg self esteem (0-30, higher is better)'}, {'measure': 'Resilience a', 'timeFrame': '6 months', 'description': 'score on Child \\& Youth Resilience Measure-Revised (0-34, higher is better)'}, {'measure': 'Resilience b', 'timeFrame': '12 months', 'description': 'score on Child \\& Youth Resilience Measure-Revised (0-34, higher is better)'}, {'measure': 'Resilience c', 'timeFrame': '24 months', 'description': 'score on Child \\& Youth Resilience Measure-Revised (0-34, higher is better)'}], 'secondaryOutcomes': [{'measure': 'Indicator for Self-Reported School Enrollment a', 'timeFrame': '12 months', 'description': 'Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)'}, {'measure': 'Indicator for Self-Reported School Enrollment b', 'timeFrame': '24 months', 'description': 'Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)'}, {'measure': 'incidence of pregnancy a', 'timeFrame': '12 months', 'description': 'incidence of pregnancy from baseline'}, {'measure': 'incidence of pregnancy b', 'timeFrame': '24 months', 'description': 'incidence of pregnancy from baseline'}, {'measure': 'Child Marriage a', 'timeFrame': '12 months', 'description': 'incidence of marriage from baseline'}, {'measure': 'Child Marriage b', 'timeFrame': '24 months', 'description': 'incidence of marriage from baseline'}, {'measure': 'Competencies a', 'timeFrame': '12 months', 'description': 'Score on competency test. This is a score that takes on a value of 0-3 across a set of three questions on ability to answer skills based math questions. Higher is better'}, {'measure': 'Competencies b', 'timeFrame': '24 months', 'description': 'Score on competency test. This is a score that takes on a value of 0-3 across a set of three questions on ability to answer skills based math questions. Higher is better'}, {'measure': 'Indicator for self -reported condom use at last sex a', 'timeFrame': '12 months', 'description': 'condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)'}, {'measure': 'indicator for self-reported condom use at last sex b', 'timeFrame': '24 months', 'description': 'condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Depression']}, 'descriptionModule': {'briefSummary': "Adolescent girls in developing countries face high rates of adversity and are at an elevated risk of depression and other forms of psychological distress. Untreated depression can have negative consequences on life outcomes such as early pregnancies, social exclusion and school dropout. These can result in a cycle of poverty for young women and their families. Despite this being a very pressing problem there is little evidence on what types of interventions can help break the vicious cycle of poor mental health and poverty.\n\nThis research program aims to evaluate, through the use of a cluster-Randomized Control Trial (cluster- RCT), the effect of group-based interpersonal psychotherapy (IPT-G) and unconditional cash transfers on adolescent girls' mental health and social functioning. Working with Strong Minds Uganda in collaboration with BRAC Uganda's Empowerment and Livelihood for Adolescents (ELA) clubs, the evidence generated from this research will create a better understanding of whether adolescent mental health improves through this cost-effective approach, and whether improved mental health impacts other outcomes of interest."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 13-19 year old female who scores 10 or above on PHQ-8\n\nExclusion Criteria:\n\n* male\n* Score below 10 on PHQ-8'}, 'identificationModule': {'nctId': 'NCT03966833', 'briefTitle': 'Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls', 'orgStudyIdInfo': {'id': 'SMU/BRAC 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group-based interpersonal therapy (IPT-G)', 'description': '14 weeks of group-based interpersonal therapy (IPT-G): StrongMinds is focused on treating depression in Uganda by training community members (in this case ELA club mentors) to act as mentors in IPT-G techniques. This intervention will be offered to 13-19 year old young women who score a 10 or higher on the PHQ-8. These adolescents who take up the offer will then be enrolled in the 14 weeks of therapy. Group therapy sessions build bonds between young women and encourage them to actively engage in the healing process and to support each other in the exploration of their depression triggers. With new healthier patterns and skills, women can learn to manage their current depression and ensure future depressive episodes can be quickly identified and resolved before the onset of any long-term consequences.', 'interventionNames': ['Behavioral: IPT-G']}, {'type': 'EXPERIMENTAL', 'label': 'IPT-G + Unconditional Cash Transfer:', 'description': 'A one time lump sum of 200,000 UGX (\\~$54) be provided to all study participants in a random sub-set of intervention (IPT-G) clusters near or at the conclusion of the 14-week therapy. This treatment variation will allow for determination of whether complimentary income support enhances the effects of IPT-G on psychological wellbeing and other outcomes of interest.', 'interventionNames': ['Behavioral: IPT-G', 'Behavioral: Unconditional Cash Transfer']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'ELA clubs function as normal'}], 'interventions': [{'name': 'IPT-G', 'type': 'BEHAVIORAL', 'description': '14 weeks of group-based interpersonal therapy (IPT-G)', 'armGroupLabels': ['IPT-G + Unconditional Cash Transfer:', 'group-based interpersonal therapy (IPT-G)']}, {'name': 'Unconditional Cash Transfer', 'type': 'BEHAVIORAL', 'description': 'Lump sum cash transfer', 'armGroupLabels': ['IPT-G + Unconditional Cash Transfer:']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'country': 'Uganda', 'facility': 'BRAC Uganda', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be made available at the conclusion of the study.', 'ipdSharing': 'YES', 'description': 'Data will be made available at the conclusion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Berk Ozler, The World Bank', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sarah Baird', 'investigatorAffiliation': 'George Washington University'}}}}