Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-10 @ 11:47 AM
Study NCT ID:
NCT07050251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bridging the Divide: A Pioneering Culturally-Specific Mentoring Intervention to Increase Support for At-Risk Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Social Emotional Competence as measured by the Social Emotional Competence Questionnaire (SECQ)', 'timeFrame': 'Baseline, post-intervention (at 10 weeks)', 'description': 'The SECQ consists of 25 items, divided into five domains:Self-Awareness, Social Awareness, Self-Management, Relationship Skills and Responsible Decision-Making.Each domain includes 5 items and each is scored from 1(never) to 5 (always) for a maximum score of 25 for each domain. An average of all 25 item responses is calculated and score range is 1.0-5.0, higher score indicating greater social emotional competence.'}, {'measure': 'Change in Parenting Sense of Competence as measured by the Parenting Sense of Competence Scale (PSOC)', 'timeFrame': 'Baseline, post-intervention (at 10 weeks)', 'description': 'The Parenting Sense of Competence Scale (PSOC) contains 16 items and each is scored on a 6-point Likert scale from 1 (Strongly Disagree) to 6 (Strongly Agree) for a maximum score of 96, higher scores indicating greater parenting competence.'}, {'measure': "Change in Psychological Well-Being as measured by Psychological Well-Being (Ryff's 18-item) assessment", 'timeFrame': 'Baseline, post-intervention (at 10 weeks)', 'description': 'Ryff\'s 18-item Psychological Well-Being Scale assesses six dimensions of well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Each subscale consists of 3 items, rated on a 6-point Likert scale from "Strongly Disagree" (1) to "Strongly Agree" (6). Maximum score is 108 and higher scores indicate greater psychological well-being.'}, {'measure': 'Change in depression, anxiety, and stress symptoms as measured by the Depression Anxiety Stress Scale (DASS-21)', 'timeFrame': 'Baseline, post-intervention (at 10 weeks)', 'description': 'DASS-21) is a validated self-report questionnaire that assesses symptoms across three domains: depression, anxiety, and stress. Each domain consists of 7 items rated on a 4-point Likert scale from 0 (Did not apply to me at all)-3( Applied to me very much, or most of the time). Scores for each domain are summed and then multiplied by 2 to match the original DASS-42 scale for a maximum score of 126. Higher scores indicate greater symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Change in Academic Self-Efficacy as measured by the Academic Self-Efficacy Scale (ASES)', 'timeFrame': 'Baseline, post-intervention (at 10 weeks)', 'description': 'ASES consists of 9 items, each rated on a 5-point Likert scale from 1(not at all confident) to 5(extremely confident) for a maximum score of 45. Higher scores indicate greater academic self-efficacy'}, {'measure': 'Change in emotional and behavioral functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': 'pre- and post-intervention assessments (at 10 weeks).', 'description': 'SDQ consists of 25 items across five subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is rated on a 3-point scale from 0 (Not True), 1 (Somewhat True) , 2 (Certainly True) for a maximums score of 40 for the Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Relationship Problems subscales and higher score indicates greater difficulties. the Prosocial Behavior subscale has a score range from 0-10 and higher score indicate more positive social behavior.'}, {'measure': 'Change in perceived social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)', 'timeFrame': 'pre- and post-intervention assessments (at 10 weeks).', 'description': 'MSPSS consists of 12 items, with 4 items in each domain, rated on a 7-point Likert scale from 1 (Very Strongly Disagree) to 7 (Very Strongly Agree) for a maximum of score of 84. Higher scores indicate greater perceived social support.'}, {'measure': 'Change in well-being as measured by the Multidimensional Well-Being Assessment (MWBA)', 'timeFrame': 'pre- and post-intervention assessments (at 10 weeks).', 'description': 'This is a 30 item questionnaire with each item scored from 1( not at all) to 5 (very often), for a maximum total score of 150. Higher scores indicate better well-being.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['at risk youth', 'Boys and Girls Clubs'], 'conditions': ['Socio-emotional Well-being', 'Psychological Well-Being']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the feasibility, acceptability, and effectiveness of a culturally-specific mentoring intervention to improve socio-emotional skills, psychological well-being, and social support among at-risk youth and to evaluate the proposed mentoring intervention's impact on academic outcomes, social behavior, and caregiver perceptions of social-emotional competencies. Additionally, it seeks to gather stakeholder feedback to refine the intervention further."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* actively enrolled in the partnering community organization (e.g., Boys and Girls Clubs)\n* Participants and their caregivers must be able to provide informed assent/consent in English. Parental Consent: Participants must have parental or guardian consent to participate in the study.\n* Self-identifies as a racial-ethnic minority (i.e., Black/African American, Hispanic, etc.)\n\nExclusion Criteria:\n\n* Current participation in another mentoring program: To avoid confounding the results, youth currently involved in other mentoring or structured socio-emotional support programs will be excluded.\n* Severe cognitive or developmental disabilities: The study will exclude participants with mental impairments that prevent meaningful engagement in focus groups or intervention activities.'}, 'identificationModule': {'nctId': 'NCT07050251', 'briefTitle': 'Bridging the Divide: A Pioneering Culturally-Specific Mentoring Intervention to Increase Support for At-Risk Youth', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Bridging the Divide: A Pioneering Culturally-Specific Mentoring Intervention to Increase Support for At-Risk Youth', 'orgStudyIdInfo': {'id': 'HSC-MS-24-1243'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentoring Intervention Delivery', 'interventionNames': ['Behavioral: Mentoring Intervention Delivery']}], 'interventions': [{'name': 'Mentoring Intervention Delivery', 'type': 'BEHAVIORAL', 'description': 'The intervention will utilize a culturally specific, socio-emotional learning (SEL) curriculum, adapted based on feedback from the focus groups. The intervention will consist of 10 weekly mentoring sessions lasting 1 hour each. Licensed clinicians will lead sessions and will also serve as mentors.', 'armGroupLabels': ['Mentoring Intervention Delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Jarrad Hodge, PhD', 'role': 'CONTACT', 'email': 'Jarrad.D.Hodge@uth.tmc.edu', 'phone': '713-486-2700'}, {'name': 'Funlola Are', 'role': 'CONTACT', 'email': 'Funlola.G.Are@uth.tmc.edu', 'phone': '(713) 486-2700'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jarrad Hodge, PhD', 'role': 'CONTACT', 'email': 'Jarrad.D.Hodge@uth.tmc.edu', 'phone': '(713) 486-2700'}, {'name': 'Funlola Are', 'role': 'CONTACT', 'email': 'Funlola.G.Are@uth.tmc.edu', 'phone': '(713) 486-2700'}], 'overallOfficials': [{'name': 'Jarrad Hodge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Research Fellow', 'investigatorFullName': 'Jarrad Hodge', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}