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

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

Sponsors

Lead Sponsor: Boston College

Collaborator: National Institute of Mental Health (NIMH)

Source Boston College
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).

Overall Status Recruiting
Start Date 2022-09-01
Completion Date 2025-08-01
Primary Completion Date 2024-04-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Provider participant recruitment rates (feasibility of conducting a larger trial) At time of training intervention
Provider participant attrition rates (feasibility of conducting a larger trial) Pre-training, post-training (up to 4 weeks after the training), 6-month follow-up, and 12-month follow-up
Self-report survey on adoption of practices learned in the training intervention 6- & 12-month follow-up
Electronic monitoring of training intervention (adoption of training intervention) From time of training through 12-month follow-up
Secondary Outcome
Measure Time Frame
Client behavioral engagement by session participation Weekly from pre-intervention to 12 months after training intervention completion
Client behavioral engagement by session attendance Weekly from pre-intervention to 12 months after training intervention completion
Therapeutic Alliance Quality Scale (client satisfaction & attitudinal engagement) Weekly from pre-intervention to 12-month follow up
Service Satisfaction Scale (client satisfaction & attitudinal engagement) Every other week from pre-intervention to 12-month follow up
Treatment Outcomes Expectation Scale (client satisfaction & attitudinal engagement) At baseline
Treatment Process Expectations Index (client satisfaction & attitudinal engagement) At baseline
Ohio Functioning Scale (client functioning) Monthly from pre-intervention to 12-month follow up
Symptoms and Functionality Severity Scale (client symptomatology & functioning) Monthly from pre-intervention to 12-month follow up
Enrollment 129
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Gender-Affirming Psychotherapy (GAP) Training

Description: 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).

Arm Group Label: Gender-Affirming Psychotherapy (GAP)

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.

Gender:

All

Gender Based:

Yes

Gender Description:

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

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Maggi Price, PhD Principal Investigator Boston College School of Social Work
Overall Contact

Last Name: Maggi Price, PhD

Phone: 5415565016

Email: [email protected]

Location
Facility: Status: Contact: Boston College 541-556-5016 [email protected]
Location Countries

United States

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Gender-Affirming Psychotherapy (GAP)

Type: Experimental

Description: The single-arm intervention study will test an online asynchronous gender-affirming training intervention called "GAP Training."

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: The single-arm intervention will test an online, asynchronous gender-affirming training intervention.

Primary Purpose: Health Services Research

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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