Clinical trial NCT05919849: Supporting Parents in Affirming Their Children's Experiences of Stigma
Official title: Development and Initial Trial of Two Brief Interventions to Support Parents in Affirming Their Children's Experiences of Sexual and Gender Identities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Keywords: Parental Acceptance
Sexual and Gender Minority Youth
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: Vanderbilt University
name: Ben-Gurion University of the Negev
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-06-26
Enrollment: 129
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this study is to develop and test the acceptability, feasibility, and preliminary efficacy of two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States. Parental support represents the strongest predictor of sexual and gender minority youth's (SGMY) mental health. However, many parents react to their SGMY's disclosure with rejection. Even relatively accepting parents can experience discomfort, while SGMY often report lingering unmet needs from their parents into adulthood. Few interventions exist to help parents support their SGMY child and none has been tested in a randomized trial with efficacy for decreasing parental rejection and increasing support of their SGMY. This proposal will develop and test the efficacy of two theory-based interventions that aim to address this gap. Results will identify mechanisms contributing to parental rejection and develop scalable approaches to reduce these mechanisms to shrink the substantial mental health disparities affecting SGMY. If efficacious, these interventions can be scaled up through online platforms capable of bypassing barriers to parental support of SGMY across high-stigma regions.

The focus of this registration is the randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Parents are eligible if they meet the following criteria:

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

   1. Self-identify as SGM,
   2. Are 15-29 years old,
   3. Live in the Southeast United States, and
   4. Have a parent enrolled in the trial

   Exclusion Criteria:
3. Any individual who meets any of the following criteria will be excluded from participation in this study:

   1. Active mania, psychosis, or suicidality, and
   2. Unable to provide informed consent.

Primary outcomes:
measure: Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Secondary outcomes:
measure: Change in Secondary Parental Acceptance and Rejection Measured By the Children's Report of Parent Behavior Inventory
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Secondary Parental Acceptance and Rejection Measured By the the Parental Acceptance/Rejection Questionnaire
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Secondary Parental Acceptance and Rejection Measured By the Five-Minute Speech Sample
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent-Child Relationship Quality and Stress Assessed by the Parental Environment Questionnaire Conflict, Involvement, and Regard for Child Subscales
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent-Child Relationship Quality and Stress Assessed by the McMaster Family Assessment Device General Functioning Subscale
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Anti-SGM Bias Assessed Using the Social Distance Scale
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Anti-SGM Bias Assessed Using the Lesbian, Gay, Bisexual Affiliate Stigma Measure
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent-Child Unresolved Conflict Measured Using the Unfinished Business Scale
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Depression and Anxiety Using the PROMIS (Patient-Reported Outcomes Measurement Information System®) Depression, Anxiety, and Anger Scales
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Perceived Stress Using the Perceived Stress Scale
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Report of Child Depression and Anxiety Using the PROMIS Depression and Anxiety Scales
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Negative Emotion Using a Modified Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Change in Parent Empathy Measured By the Questionnaire of Cognitive and Affective Empathy
timeFrame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
measure: Intervention Acceptability Measured By the Client Satisfaction Questionnaire
timeFrame: 3-Month-Post-Baseline
measure: Intervention Acceptability Measured By the Treatment Acceptability Survey
timeFrame: 3-Month-Post-Baseline
measure: Intervention Feasibility Measured By Percentage of Intervention Sessions Completed
timeFrame: Measured Throughout Intervention (Up to 2 Weeks)
measure: Intervention Feasibility Measured By Percentage of Fully Engaged Sessions
timeFrame: Measured Throughout Intervention (Up to 2 Weeks)
measure: Intervention Feasibility Measured By Number of Platform Technical/Accessibility Issues
timeFrame: Measured Throughout Intervention (Up to 2 Weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Be'er Sheva
country: Israel
facility: Ben-Gurion University
Study officials:
affiliation: Yale University
name: John E Pachankis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Lea Dougherty, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: Singh, M. (1994). Validation of a measure of session outcome in the resolution of unfinished business. Unpublished doctoral dissertation, York University, Toronto, Ontario, Canada
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.