Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 11:18 PM
Study NCT ID:
NCT04318769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D057545', 'term': 'Social Stigma'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are not blinded as they know which arm they are allocated too. Care providers and outcome assessors are blinded as the investigator runs the allocation sequence and outcomes are administered via survey weblink'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Sexual Health Capacity Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': 'Four items. Scores range from 4 to 16. Higher scores mean better outcomes.'}, {'measure': 'Abstinence Self-Efficacy Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': 'Five items. Scores range from 5 to 20. Higher scores mean better outcomes.'}, {'measure': 'Protection Self-Efficacy Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': 'Eight items. Scores range from 8 to 32. Higher scores mean better outcomes'}, {'measure': 'Change in DSM 5a Self-Rated Level 1 Cross-Cutting Symptom Measure - Child', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': 'Twenty items. Scores range from 0 to 80. Lower scores mean better outcomes.'}, {'measure': 'Change in Current Mood Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': 'Six items. Scores range from 0 to 60. Lower scores mean better outcomes.'}, {'measure': 'Change in Beck Depression Inventory-II', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': 'Twenty items. Scores range from 0 to 80. Lower scores mean better outcomes.'}, {'measure': 'Change in Brief COPE Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '28 items. Scores range from 28 to 112. Higher scores mean better outcomes.'}, {'measure': 'Change in Proactive Coping Inventory for Adolescents-A - Reflective Coping Subscale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '11 items. Scores range from 0 to 33. Higher scores mean better outcomes.'}, {'measure': 'Change in Stress Appraisal Measure for Adolescents', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '13 items. Scores range from 13 to 65. Higher scores mean better outcomes.'}, {'measure': 'Change in Adult Hope Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '12 items. Scores range from 12 to 96. Higher scores mean better outcomes.'}, {'measure': 'Change in Internalized Homophobia Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '10 items. Score range from 10 to 100. Lower scores mean better outcomes.'}, {'measure': 'Change in Everyday Discrimination Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '7 items. Scores range from 7 to 42. Higher scores mean better outcomes.'}, {'measure': 'Change in LGBTQ Microaggressions Scale', 'timeFrame': 'Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)', 'description': '15 items. Scores from 0 to 75. Lower scores mean better outcomes.'}], 'primaryOutcomes': [{'measure': 'Feasibility - participant attendance at group sessions', 'timeFrame': 'week 56', 'description': 'Proportions of participants that enroll, commence, and complete the intervention.'}, {'measure': 'Acceptability - participant satisfaction with group sessions', 'timeFrame': 'week 56', 'description': 'Participants will complete a satisfaction questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Intervention fidelity - how closely facilitators adhere to intervention model', 'timeFrame': 'Study period sessions 1-8 (weeks 1-8)', 'description': 'Independent coders will complete a checklist questionnaire of AFFIRM intervention items, based on the manual, to determine how closely intervention facilitators adhered to the model'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual and gender minority youth', 'Cognitive behavioral therapy'], 'conditions': ['Mental Health Issue', 'Hiv', 'Stigma, Social', 'Coping Skills']}, 'referencesModule': {'references': [{'pmid': '31172957', 'type': 'BACKGROUND', 'citation': 'Craig SL, McInroy LB, Eaton AD, Iacono G, Leung VW, Austin A, Dobinson C. An Affirmative Coping Skills Intervention to Improve the Mental and Sexual Health of Sexual and Gender Minority Youth (Project Youth AFFIRM): Protocol for an Implementation Study. JMIR Res Protoc. 2019 Jun 6;8(6):e13462. doi: 10.2196/13462.'}, {'pmid': '40922004', 'type': 'DERIVED', 'citation': 'Craig SL, Leung VWY, Hui JA, Iacono G, Pascoe RV, Dillon F, Austin A, Pang N, Dobinson C, Brooks AS. LGBTQ + Affirmative CBT: a hierarchical linear model of longitudinal outcomes and mechanisms of change. BMC Psychol. 2025 Sep 8;13(1):1006. doi: 10.1186/s40359-025-03314-7.'}], 'seeAlsoLinks': [{'url': 'http://www.projectyouthaffirm.org', 'label': 'Project Website'}]}, 'descriptionModule': {'briefSummary': "AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences. AFFIRM is being tested in a five-year trial using a stepped wedge waitlist crossover design, where all participants receive the intervention in clusters.", 'detailedDescription': 'Session 1 focus\n\nIntroduction to cognitive behavioral therapy (CBT), exploring lesbian, gay, bisexual, transgender, and queer (LGBTQ)+ identities, and understanding minority stress.\n\nSession 1 activities\n\nIntroductions\n\nDiscussing the theory and purpose of CBT approaches\n\nExploring stress and minority stress\n\nUnderstanding the causes of stress in our lives\n\nSession 2 focus\n\nUnderstanding the impact of anti-LGBTQ attitudes and behaviors on stress.\n\nSession 2 activities\n\nCheck in and review\n\nExamining homophobia, heterosexism, and transphobia at the individual, institutional, and cultural level\n\nIdentifying how these experiences impact thoughts, feelings, and behaviors\n\nFostering strategies for both coping with and combating anti-LGBTQ discrimination at all levels\n\nSession 3 focus\n\nUnderstanding how thoughts impact feelings.\n\nSession 3 activities\n\nCheck in and review\n\nDistinguishing between thoughts and feelings\n\nExploring how thoughts influence feelings and behaviors\n\nIdentifying counterproductive thinking patterns\n\nRecognizing negative self-talk and feelings of hopelessness\n\nLearning thought stopping\n\nSession 4 focus\n\nUsing thoughts to change feelings.\n\nSession 4 activities\n\nCheck in and review\n\nIncreasing positive thinking and feelings of hope\n\nChanging negative thoughts to positive thoughts\n\nChallenging negative thinking and internalized homophobia/negative feelings through the ABCD (activating event, belief, consequence, and debate) method\n\nSession 5 focus\n\nExploring how activities impact feelings.\n\nSession 5 activities\n\nCheck in and review\n\nExamining the impact of various activities on feelings\n\nIdentifying supportive and identity-affirming activities\n\nThe impact of LGBTQ-affirming activities on feelings\n\nSession 6 focus\n\nPlanning to overcome counterproductive thoughts and negative feelings.\n\nSession 6 activities\n\nCheck in and review\n\nDistinguishing between clear and unclear goals\n\nIdentifying short, mid-, and long-term goals\n\nCreating a sexual health plan\n\nFostering hope for the future\n\nSession 7 focus\n\nUnderstanding the impact of minority stress and anti-LGBTQ attitudes or behaviors on social relationships.\n\nSession 7 activities\n\nCheck in and review\n\nAnti-LGBTQ discrimination can lead to feelings of discomfort around others\n\nResponding to discrimination or harassment in social situations\n\nLearning to be assertive\n\nSession 8 focus\n\nPutting it all together: developing safe, supportive, and identity-affirming social networks.\n\nSession 8 activities\n\nCheck in and review\n\nMaintaining a healthy social network: attending to thoughts, expectations, feelings, and behaviors within relationships\n\nIdentifying a plan for building a supportive network'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '14 Years', 'genderBased': True, 'genderDescription': 'Participants must self-identify as a sexual minority and/or as a gender minority', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 14 to 29 years at time of screening\n* Identifies as a sexual and/or gender minority\n* Reads, writes, and speaks fluent English\n* Is interested in participating in the 8-session AFFIRM intervention\n\nExclusion Criteria:\n\n* Assessed to be in crisis (i.e., high risk of suicidality)\n* Warrenting a more intensive intervention'}, 'identificationModule': {'nctId': 'NCT04318769', 'acronym': 'AFFIRM', 'briefTitle': 'An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth (AFFIRM): A Stepped Wedge Waitlist Crossover Trial', 'orgStudyIdInfo': {'id': '35229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AFFIRM', 'description': 'AFFIRM is an 8-session psychoeducational weekly group intervention', 'interventionNames': ['Behavioral: AFFIRM']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlisted control', 'description': 'Waitlisted control'}], 'interventions': [{'name': 'AFFIRM', 'type': 'BEHAVIORAL', 'description': "AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences.", 'armGroupLabels': ['AFFIRM']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L4N5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'COMPASS Health', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8R2K8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Family Health Team', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L6H3K4', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Reach Out Centre for Kids - Positive Space Network', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'M4Y2C9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The 519 Church Street Community Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5A2S5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sherbourne Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T2E3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Asian Community AIDS Services (ACAS)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6J1H4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health (CAMH)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Shelley L Craig, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shelley Craig', 'investigatorAffiliation': 'University of Toronto'}}}}