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

NCT ID: NCT05766592

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-13

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Mental Health Issue Parent-Child Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be immediately assigned to either condition.

Study Groups

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LGBTQ-affirmative CBT

Individuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 16 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual and gender minority mental health disparities.

Group Type EXPERIMENTAL

LGBTQ-affirmative CBT

Intervention Type BEHAVIORAL

16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

ABFT-SGM

Individuals assigned to attachment-based family therapy for sexual and gender minorities will receive a 16-session sequence of family-based therapy delivered via telehealth. This sequence will include sessions with sexual and/or gender minority adult children alone, adult children and parent(s), and parent(s) alone. Sessions will address the quality parent-child relationship in relation to child sexual orientation and gender identity to target mental health disparities.

Group Type EXPERIMENTAL

ABFT-SGM

Intervention Type BEHAVIORAL

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

Interventions

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LGBTQ-affirmative CBT

16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

Intervention Type BEHAVIORAL

ABFT-SGM

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Israel Science Foundation

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John E Pachankis, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Gary M Diamond, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Locations

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Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office

New York, New York, United States

Site Status NOT_YET_RECRUITING

Ben-Gurion University Psychotherapy Research Lab

Beersheba, , Israel

Site Status RECRUITING

Countries

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United States Israel

Central Contacts

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John E Pachankis, PhD

Role: CONTACT

646-429-9407

Danielle M Chiaramonte, PhD

Role: CONTACT

708-334-8331

Facility Contacts

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Danielle M Chiaramonte, PhD

Role: primary

708-334-8331

Benjamin E Eisenstadt, BA

Role: backup

347-633-0610

Gary M Diamond, PhD

Role: primary

267-388-9393

Noam Aiziczon

Role: backup

References

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Mohr JJ, Kendra MS. Revision and extension of a multidimensional measure of sexual minority identity: the Lesbian, Gay, and Bisexual Identity Scale. J Couns Psychol. 2011 Apr;58(2):234-245. doi: 10.1037/a0022858.

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Kibrik EL, Cohen N, Stolowicz-Melman D, Levy A, Boruchovitz-Zamir R, Diamond GM. Measuring Adult Children's Perceptions of Their Parents' Acceptance and Rejection of Their Sexual Orientation: Initial Development of the Parental Acceptance and Rejection of Sexual Orientation Scale (PARSOS). J Homosex. 2019;66(11):1513-1534. doi: 10.1080/00918369.2018.1503460. Epub 2018 Aug 24.

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Steffens MC, Buchner A. Implicit Association Test: separating transsituationally stable and variable components of attitudes toward gay men. Exp Psychol. 2003;50(1):33-48. doi: 10.1027//1618-3169.50.1.33.

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Fraley RC, Heffernan ME, Vicary AM, Brumbaugh CC. The Experiences in Close Relationships-Relationship Structures questionnaire: a method for assessing attachment orientations across relationships. Psychol Assess. 2011 Sep;23(3):615-25. doi: 10.1037/a0022898.

Reference Type BACKGROUND
PMID: 21443364 (View on PubMed)

Tolin DF, Gilliam C, Wootton BM, Bowe W, Bragdon LB, Davis E, Hannan SE, Steinman SA, Worden B, Hallion LS. Psychometric Properties of a Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders. Assessment. 2018 Jan;25(1):3-13. doi: 10.1177/1073191116638410. Epub 2016 Mar 17.

Reference Type BACKGROUND
PMID: 26988404 (View on PubMed)

Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471.

Reference Type BACKGROUND
PMID: 19016462 (View on PubMed)

Cook SE, Marsiske M, McCoy KJ. The use of the Modified Telephone Interview for Cognitive Status (TICS-M) in the detection of amnestic mild cognitive impairment. J Geriatr Psychiatry Neurol. 2009 Jun;22(2):103-9. doi: 10.1177/0891988708328214.

Reference Type BACKGROUND
PMID: 19417219 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Other Identifiers

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2000034163

Identifier Type: -

Identifier Source: org_study_id

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