Development of a Training Intervention to Improve Mental Health Treatment for Gender Minority Youth

Overview

The overall goal of the larger 3-aim study is to develop and pilot test a training intervention to increase mental health providers' use of gender-affirming practices with gender minority youth (GMY; children, adolescents, and young adults whose gender is different from their birth-assigned sex). Aim 3 (registered here) of the study is an open trial pilot study at a multi-clinic mental health agency, aimed at examining the feasibility and acceptability of conducting a future randomized controlled trial (RCT).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2024

Detailed Description

The overall goal of the larger 3-aim study is to develop and pilot test a training intervention to increase mental health providers' use of gender-affirming practices with gender minority youth (GMY; children, adolescents, and young adults whose gender is different from their birth-assigned sex). The Boston College Institutional Review Board (IRB) approved protocol #21.247.01-15. Aim 1 involved designing the training intervention through an extensive literature review and community-engaged methods that centered on collaborations with providers, GMY, and caregivers. Aim 2 (in progress) entails refining the training intervention via human centered design methods. Aim 3 (registered here) of the study is an open trial pilot study at a multi-clinic mental health agency, aimed at examining the feasibility and acceptability of conducting a future randomized controlled trial (RCT). Effectiveness and implementation data from both providers (n=49) and clients (i.e., GMY and their caregivers; n=50 GMY and n=30 caregivers) will be collected and analyzed. Primary outcomes are measured at the provider-level and secondary outcomes are measured at the patient-level (i.e., GMY and their caregivers).

Interventions

  • Behavioral: Gender-Affirming Psychotherapy (GAP) Training
    • The GAP training is a modular online asynchronous training intervention designed to increase mental health providers’ use of gender-affirming practices with GMY (ages 12-25). It was developed using community-engaged and human-centered design methods with key stakeholders (GMY, their caregivers, mental health providers). In this open trial, GAP training will be offered to mental health providers at a multisite mental health clinic in the U.S. (referred to as “pilot site” herein).

Arms, Groups and Cohorts

  • Experimental: Gender-Affirming Psychotherapy (GAP)
    • The single-arm intervention study will test an online asynchronous gender-affirming training intervention called “GAP Training.”

Clinical Trial Outcome Measures

Primary Measures

  • Provider participant recruitment rates (feasibility of conducting a larger trial)
    • Time Frame: At time of training intervention
    • Percent of providers at pilot site who consented to participate in the study relative to number of employed providers at pilot site.
  • Provider participant attrition rates (feasibility of conducting a larger trial)
    • Time Frame: Pre-training, post-training (up to 4 weeks after the training), 6-month follow-up, and 12-month follow-up
    • Percent of providers who complete pre-, post-, and follow-up assessments of those who consented to participate.
  • Self-report survey on adoption of practices learned in the training intervention
    • Time Frame: 6- & 12-month follow-up
    • A survey measuring whether, and the extent to which, provider participants used the practices they learned in the training intervention. The survey is currently being developed and will be adapted based on Pachankis et al.’s (2022) measure Providers’ Familiarity With and Use of LGBTQ-affirmative cognitive behavioral therapy (CBT) Skills.
  • Electronic monitoring of training intervention (adoption of training intervention)
    • Time Frame: From time of training through 12-month follow-up
    • Electronic monitoring of training intervention engagement (e.g., number of minutes spent on each module) and completion (i.e., whether all modules were completed).

Secondary Measures

  • Client behavioral engagement by session participation
    • Time Frame: Weekly from pre-intervention to 12 months after training intervention completion
    • Available chart data from clients of providers who completed the intervention will be monitored for their behavioral engagement. Session participation will be measured by determining who (clients and/or caregivers) completed treatment measures.
  • Client behavioral engagement by session attendance
    • Time Frame: Weekly from pre-intervention to 12 months after training intervention completion
    • Available chart data from clients of providers who completed the intervention will be monitored for their behavioral engagement. Session attendance will be measured as an aspect of behavioral engagement by noting attended and canceled sessions.
  • Therapeutic Alliance Quality Scale (client satisfaction & attitudinal engagement)
    • Time Frame: Weekly from pre-intervention to 12-month follow up
    • The Therapeutic Alliance Quality Scale (TAQS) is a 5-item questionnaire that asks clients and their caregivers to reflect on their last session with their therapist. Items are rated on a 5-point scale with higher responses corresponding to higher quality alliance (e.g., 1= “Not at all,” 2= “Only a little,” 3= “Somewhat,” 4= “Quite a bit,” and 5= “Totally”). The TAQS will be administered to clients aged 12-25 and caregivers.
  • Service Satisfaction Scale (client satisfaction & attitudinal engagement)
    • Time Frame: Every other week from pre-intervention to 12-month follow up
    • The Service Satisfaction Scale (SSS) is a 5-item questionnaire that asks clients and their caregivers to reflect on how satisfied they are with the mental health services that they receive. Items are rated on a 4-point scale with higher responses corresponding to higher service satisfaction (e.g., 1= “No, definitely not,” 2= “No, not really,” 3= “Yes, generally,” and 4= “Yes, definitely”). The SSS will be administered to clients aged 12-25 and caregivers.
  • Treatment Outcomes Expectation Scale (client satisfaction & attitudinal engagement)
    • Time Frame: At baseline
    • The Treatment Outcomes Expectation Scale (TOES) is a 8-item questionnaire that asks clients and their caregivers about their expectations from counseling. Items are rated on a 3-point scale with higher responses corresponding to more expectations (e.g., 1= “I do not expect this,” 2= “I am not sure”, and 3= “I do expect this”). The TOES will be administered to clients aged 12-25 and caregivers.
  • Treatment Process Expectations Index (client satisfaction & attitudinal engagement)
    • Time Frame: At baseline
    • The Treatment Process Expectations Index is a 9-item questionnaire that asks clients and their caregivers about their expectations about counseling. Items are rated on a 3-point scale with higher responses corresponding to more expectations (e.g., 1= “I do not expect this,” 2= “I am not sure”, and 3= “I do expect this”). The TPEI will be administered to clients aged 12-25 and caregivers.
  • Ohio Functioning Scale (client functioning)
    • Time Frame: Monthly from pre-intervention to 12-month follow up
    • The Ohio Functioning Scale is a 20-item questionnaire that asks clients and their caregivers to answer questions regarding how the client’s problems may get in the way of everyday activities. Items are rated on a 5-point scale with higher responses corresponding to better ability to do everyday activities (e.g., 0= “Extreme troubles,” 1= “Quite a few troubles,” 2= “Some troubles”, 3= “Ok,” and 4= “Doing very well”).The Ohio Functioning Scale will be administered to clients aged 12-25 and caregivers.
  • Symptoms and Functionality Severity Scale (client symptomatology & functioning)
    • Time Frame: Monthly from pre-intervention to 12-month follow up
    • The Symptoms and Functionality Severity Scale which is a 13-item questionnaire that asks clients and their caregivers to reflect on behaviors, thoughts, and feelings that the client had in the last 2 weeks. Items are rated on a 5-point scale with higher responses corresponding to more frequent experiences of negative behaviors, thoughts, and feelings (e.g., 1= “Never,” 2= “Hardly Ever,” 3= “Sometimes,” 4= “Often,” and 5= “Very Often”) .The SFSS will be administered to clients aged 12-25 and caregivers.

Participating in This Clinical Trial

Inclusion Criteria

For provider participants:

  • Mental health care providers (e.g., psychologists, social workers) employed by the pilot site at the time of the pilot test and who work with clients ages 12-25 – Age 18 or older – Fluent in English For GMY participants: – Identify as a gender-minority (e.g., nonbinary, transgender, genderqueer) – Age 12-25 – Currently receiving mental health services from the pilot site – Fluent in English For caregiver of GMY participants: – Caregivers of GMY currently receiving mental health services at the pilot site – 18 or older – Fluent in English Exclusion Criteria:

  • Provided that participants meet the aforementioned inclusion criteria, there are no explicit criteria for exclusion.

Gender Eligibility: All

GMY participants will have gender-based inclusion criteria. The youth must identify as a gender-minority (e.g., nonbinary, transgender, genderqueer).

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boston College
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maggi Price, PhD, Principal Investigator, Boston College School of Social Work
  • Overall Contact(s)
    • Maggi Price, PhD, 5415565016, maggiprice1@gmail.com

References

Bidell MP. The Sexual Orientation Counselor Competency Scale: Assessing attitudes, skills, and knowledge of counselors working with lesbian, gay, and bisexual clients. Counselor Education and Supervision. 2011; 44(4): 267-279.

Pachankis JE, Soulliard ZA, Seager van Dyk I, Layland EK, Clark KA, Levine DS, Jackson SD. Training in LGBTQ-affirmative cognitive behavioral therapy: A randomized controlled trial across LGBTQ community centers. J Consult Clin Psychol. 2022 Jul;90(7):582-599. doi: 10.1037/ccp0000745.

Athay MM, Bickman L. Development and psychometric evaluation of the youth and caregiver Service Satisfaction Scale. Adm Policy Ment Health. 2012 Mar;39(1-2):71-7. doi: 10.1007/s10488-012-0407-y.

Duppong Hurley K, Lambert MC, Van Ryzin M, Sullivan J, Stevens A. Therapeutic Alliance Between Youth and Staff in Residential Group Care: Psychometrics of the Therapeutic Alliance Quality Scale. Child Youth Serv Rev. 2013 Jan 1;35(1):56-64. Epub 2012 Nov 8.

Bickman L, Kelley SD, Breda C, de Andrade AR, Riemer M. Effects of routine feedback to clinicians on mental health outcomes of youths: results of a randomized trial. Psychiatr Serv. 2011 Dec;62(12):1423-9. doi: 10.1176/appi.ps.002052011.

Bickman L, Douglas SR, De Andrade AR, Tomlinson M, Gleacher A, Olin S, Hoagwood K. Implementing a Measurement Feedback System: A Tale of Two Sites. Adm Policy Ment Health. 2016 May;43(3):410-25. doi: 10.1007/s10488-015-0647-8.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.