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

Study Overview
=================
Brief Summary
-----------------
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).

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).

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

Conditions
-----------------
Knowledge, Attitudes, Practice

Intervention / Treatment
-----------------
* Behavioral: Gender-Affirming Psychotherapy (GAP) Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The single-arm intervention will test an online, asynchronous gender-affirming training intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gender-Affirming Psychotherapy (GAP)<br>The single-arm intervention study will test an online asynchronous gender-affirming training intervention called GAP Training. | Behavioral: Gender-Affirming Psychotherapy (GAP) Training<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider participant recruitment rates (feasibility of conducting a larger trial) | Percent of providers at pilot site who consented to participate in the study relative to number of employed providers at pilot site. | At time of training intervention | 
| Change in provider participant assessment completion rates at post-training (feasibility of conducting a larger trial) | Change in the percent of providers who complete pre- and post- assessments of those who consented to participate. These assessment completion rates will also be compared to the 6- and 12-month assessment completion rates. | Pre-training to post-training (up to 4 weeks after the training) | 
| Change in provider participant assessment completion rates at 6-month followup (feasibility of conducting a larger trial) | Change in the percent of providers who complete post- and 6-month followup assessments of those who consented to participate. These assessment completion rates will also be compared to the pre-training and 12-month assessment completion rates. | Post-training (up to 4 weeks after the training) to 6-month followup | 
| Change in provider participant assessment completion rates at 12-month followup (feasibility of conducting a larger trial) | Change in the percent of providers who complete 6- and 12-month followup assessments of those who consented to participate. These assessment completion rates will also be compared to the pre-training and post-training assessment completion rates. | 6-month followup to 12-month followup | 
| Change in the adoption of practices learned in the training intervention at 12-month followup | A self-report 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 the Pachankis et al. (2022) measure Providers' Familiarity With and Use of LGBTQ-affirmative CBT Skills. The survey will be administered at the 6- and 12 month followups to see the change over time. | 6-month to 12-month followup | 
| Electronic monitoring of training intervention (adoption of training intervention) | Electronic monitoring of training intervention engagement (e.g., number of minutes spent on each module) and completion (i.e., whether all modules were completed). | up to the 12-month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client behavioral engagement by session participation | 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. | Weekly from pre-intervention to 12 months after training intervention completion | 
| Client behavioral engagement by session attendance | 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. | Weekly from pre-intervention to 12 months after training intervention completion | 
| Therapeutic Alliance Quality Scale (client satisfaction & attitudinal engagement) | 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. | Weekly from pre-intervention to 12-month follow up | 
| Service Satisfaction Scale (client satisfaction & attitudinal engagement) | 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. | Every other week from pre-intervention to 12-month follow up | 
| Treatment Outcomes Expectation Scale (client satisfaction & attitudinal engagement) | 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. | At baseline | 
| Treatment Process Expectations Index (client satisfaction & attitudinal engagement) | 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. | At baseline | 
| Ohio Functioning Scale (client functioning) | 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. | Monthly from pre-intervention to 12-month follow up | 
| Symptoms and Functionality Severity Scale (client symptomatology & functioning) | 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. | Monthly from pre-intervention to 12-month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transgender, youth, nonbinary, child, adolescent, young adult, psychologist, social worker, psychiatrist, counselor, gender, affirming, gender-affirming, gender minority, TGD, TGDY, non-binary, teen, provider, therapist, clinician, GMY, LGBT