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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05766592
Collaborator
Ben-Gurion University of the Negev (Other), Israel Science Foundation (Other)
124
1
2
53
2.3

Study Details

Study Description

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 and Connecticut. 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: LGBTQ-affirmative CBT
  • Behavioral: ABFT-SGM
Phase 3

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 and Connecticut. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants will be immediately assigned to either condition.
Primary Purpose:
Treatment
Official Title:
Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Aug 15, 2027
Anticipated Study Completion Date :
Aug 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: LGBTQ-affirmative CBT
16-session LGBTQ-affirmative psychotherapy using cognitive behavioral techniques

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in depression symptoms [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Depressive 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.

  2. Change in anxiety symptoms [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Anxiety 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 Outcome Measures

  1. Change in suicidal ideation [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Suicidal ideation will be measured using the 5-item Suicidal Ideation Attributes Scale (SIDAS). Items are rated on a scale from 0-10 (item 2 reverse coded), where higher scores indicate higher suicidal ideation, for a maximum total score of 50.

  2. Change in sexual orientation concealment motivation [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Motivation to conceal sexual minority identity 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.

  3. Change in gender identity concealment motivation [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Motivation to conceal gender minority identity will be assessed using an adapted version of 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.

  4. Change in sexual orientation acceptance concerns [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Acceptance concerns of sexual minority 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.

  5. Change in gender identity acceptance concerns [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Acceptance concerns of gender minority identity will be assessed using an adapted version of 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.

  6. Change in internalized heterosexism [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Internalized heterosexism will be assessed using the Internalized Homophobia 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 internalized heterosexism.

  7. Change in internalized cissexism [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Internalized cissexism will be assessed using an adapted version of the Internalized Homophobia 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 internalized cissexism.

  8. Change in sexual orientation identity uncertainty [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity uncertainty of sexual minority identity will be assessed using the Identity Uncertainty 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 identity uncertainty.

  9. Change in gender identity uncertainty [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity uncertainty of gender minority identity will be assessed using an adapted version of the Identity Uncertainty 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 identity uncertainty.

  10. Change in sexual orientation processing difficulty [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Difficulty in processing sexual minority identity will be assessed using the Difficult Process 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 a more difficult process.

  11. Change in gender identity processing difficulty [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Difficulty in processing gender minority identity will be assessed using an adapted version of the Difficult Process 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 a more difficult process.

  12. Change in sexual orientation identity affirmation [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity affirmation of sexual minority identity will be assessed using the Identity Affirmation 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 identity affirmation.

  13. Change in gender identity affirmation [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity affirmation of gender minority identity will be assessed using an adapted version of the Identity Affirmation 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 identity affirmation.

  14. Change in sexual orientation identity superiority [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity superiority of sexual minority identity will be assessed using the Identity Superiority 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 identity superiority.

  15. Change in gender identity superiority [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity superiority of gender minority identity will be assessed using an adapted version of the Identity Superiority 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 identity superiority.

  16. Change in sexual orientation identity centrality [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity centrality of sexual minority identity will be assessed using the Identity Centrality 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 identity centrality.

  17. Change in gender identity centrality [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Identity centrality of gender minority identity will be assessed using an adapted version of the Identity Centrality 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 identity centrality.

  18. Change in emotion dysregulation [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Emotion 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.

  19. Change in rumination [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Rumination will be measured using the 22-item Response Styles Questionnaire Rumination Scale (RSQ). Items are rated on a 4 point scale from 1-4. Items are summed for a total maximum score of 88, where higher scores indicate higher rumination.

  20. Change in implicit sexual orientation bias [Baseline, Immediate Post-intervention]

    Implicit 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.

Other Outcome Measures

  1. Change in parental acceptance of sexual orientation or gender identity [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Parental 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.

  2. Change in parental rejection of sexual orientation or gender identity [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Parental 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.

  3. Change in quality of attachment relationship [Baseline, Immediate Post-intervention, 5-month Post-intervention]

    Quality 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • be over the age of 20

  • be fluent in English

  • self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity

  • currently experience elevated depressive or anxiety disorder (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 or Connecticut.

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 DIAMOND.

  • exhibit active suicidality or active homicidality, as assessed by the SIDAS and DIAMOND

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale LGBTQ Mental Health Initiative with the Yale School of Public Health Office New York New York United States 10001

Sponsors and Collaborators

  • Yale University
  • Ben-Gurion University of the Negev
  • Israel Science Foundation

Investigators

  • Principal Investigator: John E Pachankis, PhD, Yale University
  • Principal Investigator: Gary Diamond, PhD, Ben-Gurion University of the Negev

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05766592
Other Study ID Numbers:
  • 2000034163
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University

Study Results

No Results Posted as of Mar 14, 2023