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Recruiting NCT05919849

Supporting Parents in Affirming Their Children's Experiences of Stigma

Phase I Interventional Parent-Child Relations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief online writing intervention, Control condition.
Who it may be relevant to
Registry conditions: Parent-Child Relations. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development and Initial Trial of Two Brief Interventions to Support Parents in Affirming Their Children's Experiences of Sexuality and Gender

Overview

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.

Interventions

  • Behavioral Brief online writing intervention
    Participants will be instructed to write for 20 minutes across 3 consecutive days. They will be writing based on the prompts given to them.
  • Other Control condition
    Participants will be instructed to write in order to control for time and writing engagement.

Primary outcome measures

  • Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
Secondary outcome measures (12)
  • Change in Secondary Parental Acceptance and Rejection Measured By the Children's Report of Parent Behavior Inventory [Time frame: 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 [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Secondary Parental Acceptance and Rejection Measured By the Five-Minute Speech Sample [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent Anti-SGM Bias Assessed Using the Social Distance Scale [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent Anti-SGM Bias Assessed Using the Lesbian, Gay, Bisexual Affiliate Stigma Measure [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent-Child Unresolved Conflict Measured Using the Unfinished Business Scale [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent Depression and Anxiety Using the PROMIS (Patient-Reported Outcomes Measurement Information System®) Depression, Anxiety, and Anger Scales [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent Perceived Stress Using the Perceived Stress Scale [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent Report of Child Depression and Anxiety Using the PROMIS Depression and Anxiety Scales [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]
  • Change in Parent Negative Emotion Using a Modified Positive and Negative Affect Schedule (PANAS) [Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Yale University — New Haven
  • University of Maryland — College Park
  • Vanderbilt University — Nashville
Israel · 1 center
  • Ben-Gurion University — Beersheba

Publications

  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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

Identifiers

NCT: NCT05919849 · 2000035266 · 1R21HD110617-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗