Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT05685368
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy (ACT) for Combating the Effects of Race-Related Stress Among Black Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Score on Index of Race-Related Stress (IRRS)-Brief Version', 'timeFrame': '12 weeks', 'description': 'Higher scores on this measure indicate greater race-related stress. The minimum score on this measure is 0 and the maximum is 88.'}], 'secondaryOutcomes': [{'measure': 'Total Scores on Acceptance and Action Questionnaire-2', 'timeFrame': '12 weeks', 'description': 'Higher scores on this measure indicate greater psychological flexibility. The minimum score on this measure is 7 and the maximum is 49.'}, {'measure': 'Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t)', 'timeFrame': '12 weeks', 'description': 'Higher scores on this measure indicate stronger racial identity. The minimum score on this measure is 21 and the maximum is 105.'}, {'measure': 'Total Score on Patient Health Questionaire-9', 'timeFrame': '12 weeks', 'description': 'Higher scores indicate greater depression. The minimum score on this measure is 0 and the maximum is 27.'}, {'measure': 'Total Score on General Anxiety Disorder-7', 'timeFrame': '12 weeks', 'description': 'Higher scores indicate greater anxiety. The minimum score on this measure is 0 and the maximum is 21.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Black', 'African American', 'Adolescents', 'Acceptance and Commitment Therapy', 'race-related stress', 'racial trauma', 'coping'], 'conditions': ['Race-related Stress', 'Depression, Anxiety', 'Quality of Life', 'Stress Reaction']}, 'descriptionModule': {'briefSummary': 'The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as Black/African American\n* English-speaking\n\nExclusion Criteria:\n\n* Prisoners or youth in detention centers will be excluded.\n* Not capable of participating meaningfully in the assent/consent process.\n* Being at significant risk for suicide and self-injury\n* Currently experiencing psychosis\n* Having severe health concerns that will impact study participation or attendance'}, 'identificationModule': {'nctId': 'NCT05685368', 'briefTitle': 'Acceptance and Commitment Therapy (ACT) for Combating the Effects of Race-Related Stress Among Black Adolescents', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'The Healing Power of Acceptance: Evaluating the Efficacy of Acceptance and Commitment Therapy (ACT) in Combating the Effects of Race-Related Stress Among Black Adolescents', 'orgStudyIdInfo': {'id': 'CHLA-23-00089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance Commitment Therapy', 'description': 'This study will use a 10-session ACT protocol to support Black adolescents and young adults in coping with race related stress.', 'interventionNames': ['Behavioral: ACT for Race Related Stress']}], 'interventions': [{'name': 'ACT for Race Related Stress', 'type': 'BEHAVIORAL', 'description': 'This intervention will be guided by: Payne, J. S. (2022). Out of the Fire: Healing Black Trauma Caused by Systemic Racism Using Acceptance and commitment Therapy New Harbinger Publications, Inc.', 'armGroupLabels': ['Acceptance Commitment Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Xzania W Lee, Ph.D.', 'role': 'CONTACT', 'email': 'xlee@chla.usc.edu', 'phone': '323-361-4768'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Xzania Lee, PhD', 'role': 'CONTACT', 'email': 'xlee@chla.usc.edu', 'phone': '323.361.4768'}], 'overallOfficials': [{'name': 'Xzania Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xzania Lee', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}