Supporting Parents in Affirming Their Children's Experiences of Stigma

NCT05919849 | Recruiting Phase 1 DMC

• 2 other identifiers: 20000352661R21HD110617-01A1
• Study Type: interventional
• Target: 129
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.

Conditions

Parent-Child Relations

Keywords

Parental Acceptance; Sexual and Gender Minority Youth

Outcome Measures

Primary Outcomes (1)

• Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale

  The 10-item Parent Non-Acceptance Scale is a self-reported instrument assessing positive and negative indicators of parental acceptance of their SGMY. Parents report level of agreement on a scale from 1 (Strongly Disagree) to 6 (Strongly Agree), with a higher score on negative indicators representing a higher level of non-acceptance and a higher score on positive indicators representing a lower level of non-acceptance.

  Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

Secondary Outcomes (18)

• Change in Secondary Parental Acceptance and Rejection Measured By the Children's Report of Parent Behavior Inventory

  Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

• Change in Secondary Parental Acceptance and Rejection Measured By the the Parental Acceptance/Rejection Questionnaire

  Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

• Change in Secondary Parental Acceptance and Rejection Measured By the Five-Minute Speech Sample

  Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

• Change in Parent-Child Relationship Quality and Stress Assessed by the Parental Environment Questionnaire Conflict, Involvement, and Regard for Child Subscales

  Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

• Change in Parent-Child Relationship Quality and Stress Assessed by the McMaster Family Assessment Device General Functioning Subscale

  Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

Study Arms (3)

Expressive Writing (EW)

EXPERIMENTAL

Participants in the expressive writing (EW) condition will be instructed to write in a free-form manner about the most stressful aspects of being a parent of an SGMY, following standard EW procedures.

Behavioral: Brief online writing intervention

Attachment-Based Writing (ABW)

EXPERIMENTAL

Participants in the attachment-based writing (ABW) condition will respond to distinct prompts created for the condition based on components of attachment-based family therapy (ABFT).

Behavioral: Brief online writing intervention

Neutral Writing (Control)

OTHER

Participants in the control condition will be asked to write about what they have done since waking up that morning.

Other: Control condition

Interventions

Control condition OTHER

Participants will be instructed to write in order to control for time and writing engagement.

Neutral Writing (Control)

Brief online writing intervention BEHAVIORAL

Participants will be instructed to write for 20 minutes across 3 consecutive days. They will be writing based on the prompts given to them.

Attachment-Based Writing (ABW); Expressive Writing (EW)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents are eligible if they meet the following criteria:
• Be a parent, grandparent, or any other family member who considers themselves a guardian of an SGMY between 15-29 years old,
• Live in the Southeast United States (Louisiana, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Tennessee, Arkansas, Kentucky, Florida),
• Identify as heterosexual and cisgender, and
• Report non-acceptance of their SGMY.
• SGMY are eligible if they meet the following criteria:
• Self-identify as SGM,
• Are 15-29 years old,
• Live in the Southeast United States, and
• Have a parent enrolled in the trial

You may not qualify if:

• Any individual who meets any of the following criteria will be excluded from participation in this study:
• Active mania, psychosis, or suicidality, and
• Unable to provide informed consent.

Sponsors & Collaborators

• Yale University: lead
• University of Maryland: collaborator
• Vanderbilt University: collaborator
• Ben-Gurion University of the Negev: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

University of Maryland

College Park, Maryland, 20742, United States

NOT YET RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

NOT YET RECRUITING

Ben-Gurion University

Beersheba, 84105, Israel

NOT YET RECRUITING

Related Publications (17)

• Clark, K. A., Dougherty, L. R., & Pachankis, J. E. (2021). A study of parents of sexual and gender minority children: Linking parental reactions with child mental health. Psychology of Sexual Orientation and Gender Diversity, Advance online publication.

  BACKGROUND

• Schludermann E, Schludermann S. Children's Report on Parent Behavior (CRPBI-108, CRPBI-30) Winnipeg, Canada: Unpublished manuscript, Department of Psychology, University of Manitoba; 1988.

  BACKGROUND

• Rohner, R. P. (2005). Parental acceptance-rejection/control questionnaire (PARQ/Control): Test manual. In R. P. Rohner & A. Khaleque (Eds.), Handbook for the study of parental acceptance and rejection (4th ed., pp. 137-186). Rohner Research Publications.

  BACKGROUND

• Weston, S., Hawes, D. J., & S Pasalich, D. (2017). The five-minute speech sample as a measure of parent-child dynamics: Evidence from observational research. Journal of Child and Family Studies, 26(1), 118-136. https://doi.org/10.1007/s10826-016-0549-8

  BACKGROUND

• Elkins IJ, McGue M, Iacono WG. Genetic and environmental influences on parent-son relationships: evidence for increasing genetic influence during adolescence. Dev Psychol. 1997 Mar;33(2):351-63. doi: 10.1037//0012-1649.33.2.351.

  PMID: 9147842 BACKGROUND

• Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster Family Assessment Device. Journal of Marital and Family Therapy. Vol 9 (2) 171-180. https://doi.org/10.1111/j.1752-0606.1983.tb01497.x

  BACKGROUND

• Link, B. G., Cullen, F. T., Frank, J., & Wozniak, J. F. (1987). The social rejection of former mental patients: Understanding why labels matter. American Journal of Sociology, 6, 1461-1500.

  BACKGROUND

• Robinson MA, Brewster ME. Understanding affiliate stigma faced by heterosexual family and friends of LGB people: A measurement development study. J Fam Psychol. 2016 Apr;30(3):353-63. doi: 10.1037/fam0000153. Epub 2015 Sep 28.

  PMID: 26414416 BACKGROUND

• Singh, M. (1994). Validation of a measure of session outcome in the resolution of unfinished business. Unpublished doctoral dissertation, York University, Toronto, Ontario, Canada

  BACKGROUND

• Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27.

  PMID: 26931289 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Teresi JA, Ocepek-Welikson K, Kleinman M, Ramirez M, Kim G. Psychometric Properties and Performance of the Patient Reported Outcomes Measurement Information System(R) (PROMIS(R)) Depression Short Forms in Ethnically Diverse Groups. Psychol Test Assess Model. 2016;58(1):141-181.

  PMID: 28553573 BACKGROUND

• Clover K, Lambert SD, Oldmeadow C, Britton B, Mitchell AJ, Carter G, King MT. Convergent and criterion validity of PROMIS anxiety measures relative to six legacy measures and a structured diagnostic interview for anxiety in cancer patients. J Patient Rep Outcomes. 2022 Jul 20;6(1):80. doi: 10.1186/s41687-022-00477-4.

  PMID: 35857151 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Reniers RL, Corcoran R, Drake R, Shryane NM, Vollm BA. The QCAE: a Questionnaire of Cognitive and Affective Empathy. J Pers Assess. 2011 Jan;93(1):84-95. doi: 10.1080/00223891.2010.528484.

  PMID: 21184334 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Craig SL, Austin A. The AFFIRM open pilot feasibility study: A brief affirmative cognitive behavioral coping skills group intervention for sexual and gender minority youth. Children and Youth Services Review. 2016 May 1;64:136-44.

  BACKGROUND

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• John E Pachankis, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Lea Dougherty, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Chiaramonte, Ph.D.

CONTACT

646-429-9407; danielle.chiaramonte@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be made aware of the writing intervention they will complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a 3-arm randomized control trial (RCT) design in which an anticipated129 parents of SGMY will be randomized into one of three conditions.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All data will become available once study results are submitted by the study team.
• Access Criteria: The data are available by request to qualified researchers. To access the data, a proposal should be submitted by an applicant with a Ph.D. or an equivalent degree. Proposals will be scrutinized and granted according to principles of ethical and scientific soundness, including: 1. A commitment to using the data only for research purposes and to not identify any individual participant; 2. A commitment to securing the data using appropriate information technology; and 3. A commitment to destroying the data after analyses are completed.

Locations

US (3); IL (1)