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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05766592
Enrollment
124
Registered
2023-03-13
Start date
2024-08-13
Completion date
2027-06-30
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue, Parent-Child Relations

Keywords

LGBTQ, Cognitive Behavioral Therapy, Attachment-Based Family Therapy

Brief summary

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).

Detailed description

The purpose of this study is to assess the efficacy and purported change mechanisms in 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 in New York, Pennsylvania, Connecticut, and Israel. In this 2-arm randomized clinical trial (RCT), participants will receive 16 weekly sessions of either LGBTQ-affirmative CBT or ABFT-SGM. Investigators will assess whether both treatments are associated with significant decreases in depressive and anxiety symptoms. Investigators will also assess whether psychosocial mechanisms (e.g., rejection sensitivity, internalized stigma, emotion dysregulation, parental rejection and acceptance) mediate reductions in psychological symptoms, and whether such mediators differ between the two treatments. Finally, investigators will assess whether participants who begin treatment with higher levels of parental rejection benefit more from ABFT-SGM than from LGBTQ-affirmative CBT, and whether participants with higher initial levels of maladaptive stress responses benefit more from LGBTQ-affirmative CBT.

Interventions

BEHAVIORALLGBTQ-affirmative CBT

16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

BEHAVIORALABFT-SGM

16-session attachment-based family therapy for sexual and gender minority young adults and their nonaccepting parents

Sponsors

Ben-Gurion University of the Negev
CollaboratorOTHER
Israel Science Foundation
CollaboratorOTHER
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will be immediately assigned to either condition.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* be 20 and older * be fluent in English * self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity * currently experience elevated depressive or anxiety symptoms (screened initially using a cutoff of ≥ 2.5 on the Brief Symptom Inventory-4 and further confirmed by the BDI and BAI). * report at least moderate levels of parental rejection or low levels of parental acceptance, as measured using the PARSOS. * have at least one rejecting/nonaccepting parent that agrees to participate in the therapy. * live in New York State, Pennsylvania, Connecticut, or Israel.

Exclusion criteria

* report current mental health treatment ≥1 day/month (except for medication management ≤1 day/week) * report beginning a new medication within the past 30 days * exhibit active psychosis or active mania, as assessed by the SCID-Psych Screen. * exhibit active suicidality or active homicidality, as assessed by the SIDAS * be currently legally mandated to attend treatment * demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status * do not have a parent willing to participate

Design outcomes

Primary

MeasureTime frameDescription
Change in depression symptomsBaseline, Immediate Post-intervention, 5-month Post-interventionDepressive symptoms will be measured using the 21-item Beck Depression Inventory-II (BDI). Items are rated on a scale from 0-3 where higher scores indicate greater depression symptoms, with a maximum score of 63.
Change in anxiety symptomsBaseline, Immediate Post-intervention, 5-month Post-interventionAnxiety symptoms will be measured using the 21-item Beck Anxiety Inventory (BAI). Items are rated on a scale from 0-3 where higher scores indicate greater anxiety symptoms, with a maximum score of 63.

Secondary

MeasureTime frameDescription
Change in sexual orientation and gender modality acceptance concerns, as relevantBaseline, Immediate Post-intervention, 5-month Post-interventionAcceptance concerns of sexual minority identity and gender identity will be assessed using the Acceptance Concerns subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher acceptance concerns.
Change in explicit internalized stigmaBaseline, Immediate Post-intervention, 5-month Post-interventionChange in explicit internalized stigma will be assessed using the Internalized Homonegativity subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher acceptance concerns.
Change in emotion dysregulationBaseline, Immediate Post-intervention, 5-month Post-interventionEmotion dysregulation will be assessed using the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). Items are rated on a 5-point scale from 1-5; items 1, 4, and 6 are reverse coded. Items are averaged for a total maximum score of 5, where higher scores indicate higher emotion dysregulation.
Change in suicidal ideationBaseline, Immediate Post-intervention, 5-month Post-interventionSuicidal ideation will be measured using a single item from the Patient Health Questionnaire-9. This item is rated from 0-3, where a higher score indicates higher suicidal ideation.
Change in parental acceptance of sexual orientation or gender modality, as relevantBaseline, Immediate Post-intervention, 5-month Post-interventionParental acceptance will be measured by the Parental Acceptance subscale of the Parental Acceptance and Rejection of Sexual Orientation and Gender Identity Scale (PARSOS). 15 items are rated on a 5-point scale from 1-5. Items are averaged for a maximum total score of 5, indicating higher parental acceptance.
Change in parental rejection of sexual orientation or gender modality, as relevantBaseline, Immediate Post-intervention, 5-month Post-interventionParental rejection will be measured by the Parental Rejection subscale of the Parental Acceptance and Rejection of Sexual Orientation and Gender Identity Scale (PARSOS). 13 items are rated on a 5-point scale from 1-5. Items are averaged for a maximum total score of 5, indicating higher parental rejection.
Change in quality of attachment relationshipBaseline, Immediate Post-intervention, 5-month Post-interventionQuality of attachment relationship will be assessed using the Experience in Close Relationships-Relationship Structures Questionnaire (ECR-RS). 9 items are rated on a scale from 1-7 and averaged for a total maximum score of 7, indicating a higher quality of attachment relationship.
Change in implicit sexual orientation biasBaseline, Immediate Post-interventionImplicit bias related to sexual orientation will be measured using the sexual orientation Implicit Association Test. Scores range from -2 to 2, where higher scores indicate higher implicit preference towards heterosexuality.
Change in sexual orientation and gender modality concealment motivation, as relevantBaseline, Immediate Post-intervention, 5-month Post-interventionMotivation to conceal sexual orientation and gender modality will be assessed using the Concealment Motivation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a maximum total score of 6. Higher scores indicate higher concealment motivation.

Countries

Israel, United States

Contacts

Primary ContactJohn E Pachankis, PhD
john.pachankis@yale.edu646-429-9407
Backup ContactDanielle M Chiaramonte, PhD
danielle.chiaramonte@yale.edu708-334-8331

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026