Parent-Child RelationsPhase 1SPACESNCT05919849
Supporting Parents in Affirming Their Children's Experiences of Stigma
A Phase 1 study testing Brief online writing intervention in people with Parent-Child Relations, run by Yale University at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Brief online writing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 Nov 2023to 12 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- Self-identify as SGM,
- Are 15-29 years old,
- Live in the Southeast United States, and
- Have a parent enrolled in the trial
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Maryland
College Park, Maryland, 20742
Vanderbilt University
Nashville, Tennessee, 37235
Yale University
New Haven, Connecticut, 06510
About this study
Official title: Development and Initial Trial of Two Brief Interventions to Support Parents in Affirming Their Children's Experiences of Sexuality and Gender
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.
Read the 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.
- Conditions
- Parent-Child Relations
- Being tested
- Brief online writing intervention, Control condition
- Keywords
- Parental Acceptance, Sexual and Gender Minority Youth
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief online writing interventionBehavioural
Participants will be instructed to write for 20 minutes across 3 consecutive days. They will be writing based on the prompts given to them.
Control conditionOther
Participants will be instructed to write in order to control for time and writing engagement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Other: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Children's Report of Parent Behavior Inventory (CRPBI) is a 10-item rejection/support subscale assessing level of rejection/support. Parents report how much each statement describes the way they acted towards their SGMY ranging from 1 (not like you) to 3 (a lot like you), where Acceptance and Psychological Control scores are the totals of the individual items in the respective sub-scales, and Firm Control score is obtained by taking the sum of the Firm Control + subscale, adding 24, and by then subtracting the total of the Firm Control -- subscale.
Measured: 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
The 24-item Parental Acceptance/Rejection Questionnaire describes the way parents act towards their children. Parents report how true each statement is on a scale from 1 (almost always true of me) to 4 (almost never true of me) where a higher score indicates a higher level of rejection.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Secondary Parental Acceptance and Rejection Measured By the Five-Minute Speech Sample
The Five-Minute Speech Sample (FMSS) is a measure of parent-child dynamics where parents talk for 5 minutes about their thoughts and feelings about their SGMY. The qualitative interview is coded and scored appropriately to measure parental behavior towards their SGMY
Measured: 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
The Parental Environment Questionnaire Conflict (12-item), Involvement (12-item), and Regard for Child (5-item) Subscales assess perceptions of parent-child relationship quality. Parents rate how true each statement is on a scale from 1 (definitely true) to 5 (definitely false), where a high score on the conflict scale indicates greater parental conflict, a high score on the involvement scale indicates less parental involvement, and a high score on the regard for child scale indicates high regard for child.
Measured: 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
The 12-item McMaster Family Assessment Device General Functioning Subscale further assesses perceived parent-child relationship quality and stress on a scale of "strongly agree" (1) to "strongly disagree" (4), where a higher score indicates lower general family functioning.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Anti-SGM Bias Assessed Using the Social Distance Scale
The Social Distance Scale assesses anti-LGBTQ (Lesbian, Gay, Bisexual, Trans, Queer) stigma by assessing parents' responses to different scenarios from 0 (definitely unwilling or completely uncomfortable) to 3 (definitely willing or completely comfortable), where a lower score indicates stronger anti-LGBTQ stigma.
Measured: 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
The Lesbian, Gay, Bisexual Affiliate Stigma Measure (LGB-ASM) measures affiliate stigma faced by heterosexual family and friends of sexual minority people. Parents rate how much they agree with each statement on a scale from 1 (strongly disagree) to 6 (strongly agree), with the option to claim "not applicable." A higher score indicates stronger affiliate stigma.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent-Child Unresolved Conflict Measured Using the Unfinished Business Scale
The 11-item Unfinished Business Scale was adapted by Principal Investigator Pachankis with strong psychometric properties to measure parents' unresolved negative thoughts and feelings towards their SGMY. Parents rate statements about their SGM child on a scale from 1 (not at all) to 5 (very much), where a higher score represents greater unresolved parent-child conflict.
Measured: 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
The 63-item PROMIS Depression, Anxiety, and Anger questionnaires measure parent-reported frequency of depression, anxiety, and anger symptoms over the past 7 days on a scale from 1 (never) to 5 (always), where higher scores indicate higher severity of symptoms.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Perceived Stress Using the Perceived Stress Scale
The 10-item Perceived Stress Scale assesses parents' perceived stress by asking about frequency of thoughts and feelings during the past month on a scale from 0 (never) to 4 (very often), where a higher score indicates a higher level of perceived stress.
Measured: 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
The 15-item proxy-report PROMIS Depression and Anxiety Scales measures parent report of their SGM child's depression and anxiety symptoms by asking frequency of the SGMY's symptoms over the past 7 days on a scale from 1 (never) to 5 (always), where higher scores indicate a greater severity of parent-reported symptoms.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Negative Emotion Using a Modified Positive and Negative Affect Schedule (PANAS)
The 20-item Positive and Negative Affect Schedule (PANAS) inquires about parents' positive and negative affect towards their SGMY. Participants indicate how often they have felt either positive or negative indicators on a scale of 1 (very slightly or not at all) to 5 (extremely). A high score on positive affect indicators indicates a higher positive affect towards the SGMY, while a high score on negative affect indicates a higher negative affect towards the SGMY.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Change in Parent Empathy Measured By the Questionnaire of Cognitive and Affective Empathy
The 31-item Questionnaire of Cognitive and Affective Empathy (QCAE) measures parent empathy toward their SGMY. Parents rate how much a statement relates to them on a scale of 1 (strongly disagree) to 4 (strongly agree), where a high score indicates a high level of empathy toward the SGMY.
Measured: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Intervention Acceptability Measured By the Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire is an 8-item measurement of perceived helpfulness, likelihood of recommending, and positive experience. Participants rate statements on a scale of 1 (most negative) to 4 (most positive), with a high score representing a higher level of satisfaction.
Measured: 3-Month-Post-Baseline
Intervention Acceptability Measured By the Treatment Acceptability Survey
The 17-item Treatment Acceptability Survey assesses perceived helpfulness, likelihood of recommending, and positive experience of the interventions. Participants rate statements on a scale of 1(strongly disagree) to 4 (strongly agree), with a higher score representing a higher level of acceptability.
Measured: 3-Month-Post-Baseline
Intervention Feasibility Measured By Percentage of Intervention Sessions Completed
Intervention feasibility will be partially measured by the percentage of intervention sessions participants complete.
Measured: Measured Throughout Intervention (Up to 2 Weeks)
Intervention Feasibility Measured By Percentage of Fully Engaged Sessions
Intervention feasibility will be partially measured by the percentage of fully engaged sessions, defined as the number of writing sessions that included at least 313 words.
Measured: Measured Throughout Intervention (Up to 2 Weeks)
Intervention Feasibility Measured By Number of Platform Technical/Accessibility Issues
Intervention feasibility will partially be tracked by the number of platform technical or accessibility issues noted throughout the intervention.
Measured: Measured Throughout Intervention (Up to 2 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start29 Nov 2023
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Vanderbilt University, Ben-Gurion University of the Negev, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- John E Pachankis, Ph.D., Principal investigator, Yale UniversityLea Dougherty, Ph.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919849
- Sponsor's protocol ID
- 2000035266
- Other IDs
- 1R21HD110617-01A1
- Acronym
- SPACES
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated baseline and follow-up data will be uploaded to the National Institute of Mental Health Data Archive (NDA) following the conclusion of the study. All participants will be informed of the study's confidential data sharing procedures at the time of consent. Given the personal and sensitive nature of data contained in the intervention writing samples, qualitative interviews, and the 5-minute speech task, these data will be uploaded in aggregate. De-identified individual participant data (IPD) (i.e., questionnaires, data dictionaries) generated with funds from this grant will be freely distributed, as available, to qualified academic investigators for non-commercial research. The study investigators as well as their institutions will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the "Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Grants and Contracts" issued in 2003.
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.
PubMed 9147842Epstein, 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.
PubMed 26414416Singh, M. (1994). Validation of a measure of session outcome in the resolution of unfinished business. Unpublished doctoral dissertation, York University, Toronto, Ontario, Canada
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.
PubMed 26931289Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Teresi 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.
PubMed 28553573Clover 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.
PubMed 35857151Watson 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.
PubMed 3397865Reniers 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.
PubMed 21184334
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Initial Trial of Two Brief Interventions to Support Parents in Affirming Their Children's Experiences of Sexuality and Gender
- ClinicalTrials.gov ID
- NCT05919849
- Acronym / sponsor ID
- SPACES / 2000035266
- Conditions
- Parent-Child Relations
- Keywords
- Parental Acceptance, Sexual and Gender Minority Youth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, Vanderbilt University, Ben-Gurion University of the Negev, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing (EW) | Experimental | Behavioral: Brief online writing interventionParticipants 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. |
| Attachment-Based Writing (ABW) | Experimental | Behavioral: Brief online writing interventionParticipants 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). |
| Neutral Writing (Control) | Other | Other: Control conditionParticipants in the control condition will be asked to write about what they have done since waking up that morning. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Parents are eligible if they meet the following criteria:
- SGMY are eligible if they meet the following criteria:
Key exclusion criteria (3 listed)
- Any individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief online writing interventionParticipants will be instructed to write for 20 minutes across 3 consecutive days. They will be writing based on the prompts given to them. | Behavioural | Attachment-Based Writing (ABW), Expressive Writing (EW) |
| Control conditionParticipants will be instructed to write in order to control for time and writing engagement. | Other | Neutral Writing (Control) |
Primary outcome
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
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.
18 secondary outcomes
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
Change in Parent Empathy Measured By the Questionnaire of Cognitive and Affective Empathy
Time frame: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline
Intervention Acceptability Measured By the Client Satisfaction Questionnaire
Time frame: 3-Month-Post-Baseline
Intervention Acceptability Measured By the Treatment Acceptability Survey
Time frame: 3-Month-Post-Baseline
Intervention Feasibility Measured By Percentage of Intervention Sessions Completed
Time frame: Measured Throughout Intervention (Up to 2 Weeks)
Intervention Feasibility Measured By Percentage of Fully Engaged Sessions
Time frame: Measured Throughout Intervention (Up to 2 Weeks)
Intervention Feasibility Measured By Number of Platform Technical/Accessibility Issues
Time frame: Measured Throughout Intervention (Up to 2 Weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- BackgroundClark, 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.
- BackgroundSchludermann E, Schludermann S. Children's Report on Parent Behavior (CRPBI-108, CRPBI-30) Winnipeg, Canada: Unpublished manuscript, Department of Psychology, University of Manitoba; 1988.
- BackgroundRohner, 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.
- BackgroundWeston, 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: PubMed 9147842Elkins 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.
- BackgroundEpstein, 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
- BackgroundLink, 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: PubMed 26414416Robinson 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.
- BackgroundSingh, M. (1994). Validation of a measure of session outcome in the resolution of unfinished business. Unpublished doctoral dissertation, York University, Toronto, Ontario, Canada
- Background: PubMed 26931289Schalet 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 28553573Teresi 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.
- Individual participant dataSharing planned: Yes. Aggregated baseline and follow-up data will be uploaded to the National Institute of Mental Health Data Archive (NDA) following the conclusion of the study. All participants will be informed of the study's confidential data sharing procedures at the time of consent. Given the personal and sensitive nature of data contained in the intervention writing samples, qualitative interviews, and the 5-minute speech task, these data will be uploaded in aggregate. De-identified individual participant data (IPD) (i.e., questionnaires, data dictionaries) generated with funds from this grant will be freely distributed, as available, to qualified academic investigators for non-commercial research. The study investigators as well as their institutions will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the "Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Grants and Contracts" issued in 2003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Pachankis, Ph.D. principal investigator
Yale University
Lea Dougherty, Ph.D. principal investigator
University of Maryland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brief online writing intervention in people with Parent-Child Relations, run by Yale University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919849, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.