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Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents

StatusRecruiting
PhasePhase 3
Started2024-08-13
View on ClinicalTrials.gov ↗

Amendment history

2026-01-12
Study Status v9
Re-verified, no change to tracked fields
2025-08-01
Study Status, Eligibility, IPDSharing v8
Start date2024-06-09→2024-08-13
Eligibility criteria-2 characters
[...] dentity currently experience elevated depressive or anxiety disordersymptoms (screened initially using a cutoff of ≥ 2.5 on the Brief Sy [...] xhibit active psychosis or active mania, as assessed by the DIAMONDSCID-Psych Screen. exhibit active suicidality or active homicidality, as assessed by the SIDAS and DIAMOND be currently legally mandated to attend treatment demonstra [...]
2024-09-06
Study Status v7
Primary completion date2027-09-15→2027-06-30
Completion date2027-09-15→2027-06-30
2024-06-14
Study Status v6
Start dateestimated 2024-06-15→confirmed 2024-06-09
2024-05-23
Study Status v5
Start date2024-04-30→2024-06-15
Show 4 earlier versions
2024-04-26
Study Status, Study Description, Outcome Measures, Eligibility v4
Start date2023-04-15→2024-04-30
Eligibility criteria+8 characters
Inclusion Criteria: be over20 theand age of 20older be fluent in English self-identify as lesbian, bisexual, qu [...] rees to participate in the therapy. live in New York State, Pennsylvania, Connecticut, or Israel. Exclusion Criteria: report current m [...]
Secondary endpoints20 to 9 entries
Change in sexual orientation concealment motivation Change inand gender identitymodality concealment motivation, as relevant Change in sexual orientation and gender modality acceptance concerns, as relevant Change in genderexplicit identityinternalized acceptance concernsstigma Change in internalizedparental heterosexismacceptance of sexual orientation or gender modality, as relevant Change in internalizedparental cissexismrejection of sexual orientation or gender modality, as relevant Change in sexualquality orientationof identityattachment uncertainty Change in gender identity uncertainty Ch [...] [...]
Study description+14 characters
[...] a sample of sexual and gender minority adults in New York, Pennsylvania, Connecticut, and Israel. In this 2-arm randomized clinical t [...]
2023-05-16
Not Yet Recruiting→Recruiting Study Status, Oversight, Study Description, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites1→2
Eligibility criteria+9 characters
[...] agrees to participate in the therapy. live in New York State, Connecticut, or ConnecticutIsrael. Exclusion Criteria: report current mental health treatment [...]
Study description+9 characters
[...] to a sample of sexual and gender minority adults in New York, Connecticut, and ConnecticutIsrael. In this 2-arm randomized clinical trial (RCT), participant [...]
2023-03-28
Study Status, Outcome Measures, References v2
Primary completion date2027-08-15→2027-09-15
Completion date2027-08-15→2027-09-15
Start date2023-03-15→2023-04-15
Secondary endpointsdetails revised at 1 of 20 entries
Publications12 entries, revised
vanKroenke Spijker BAK, BatterhamSpitzer PJRL, CalearWilliams AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJJB. The suicidal ideation attributes scale (SIDAS)PHQ-9: Community-based validation studyvalidity of a newbrief scaledepression forseverity the measurement of suicidal ideationmeasure. SuicideJ LifeGen ThreatIntern BehavMed. 20142001 AugSep;4416(49):408606-1913. doi: 10.11111046/sltbj.120841525-1497. Epub 2014 Feb 242001.016009606.x.
2023-03-10
Study Identification, Study Status, Study Description, Outcome Measures v1
Secondary endpoints20 entries, revised
Change in sexual orientation difficultprocessing processdifficulty Change in gender identity difficultprocessing processdifficulty
Study description+33 characters
[...] eekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM. WeInvestigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. WeInvestigators will also assess whether psychosocial mechanisms (e.g., rej [...] such mediators differ between the two treatments. Finally, weinvestigators will assess whether participants who begin treatment with h [...]
Study title+9 characters
Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents
2023-03-01
Original filing
Yale University
487 trials monitored
See 35 trials at risk
The purpose of this study is to assess the efficacy of an LGBTQ-affirmative individual cognitive behavioral psychotherapy (CBT) and LGBTQ-affirmative family therapy (attachment-based family therapy for sexual and gender minority young adults; ABFT-SGM) delivered via telehealth to a sample of sexual and gender minority adults with nonaccepting parent(s) in New York, Pennsylvania, Connecticut, and Israel. The investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. The investigators will also assess whether and how each treatment achieves reductions in mental health symptoms through specific mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance).
Trial Details
NCT Number NCT05766592
Lead Sponsor Yale University
Collaborators: Ben-Gurion University of the Negev, Israel Science Foundation
Conditions Mental Health Issue, Parent-Child Relations
Enrollment 124 participants
Start Date 2024-08-13
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-13