Clinical trial NCT05626231: Development of a Training Intervention to Improve Mental Health Treatment for Gender Minority Youth
Official title: Development of a Training Intervention to Improve Mental Health Treatment for Gender Minority Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: 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
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-11-23
Enrollment: 232
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The single-arm intervention will test an online, asynchronous gender-affirming training intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Provider participant recruitment rates (feasibility of conducting a larger trial)
timeFrame: At time of training intervention
measure: Change in provider participant assessment completion rates at post-training (feasibility of conducting a larger trial)
timeFrame: Pre-training to post-training (up to 4 weeks after the training)
measure: Change in provider participant assessment completion rates at 6-month followup (feasibility of conducting a larger trial)
timeFrame: Post-training (up to 4 weeks after the training) to 6-month followup
measure: Change in provider participant assessment completion rates at 12-month followup (feasibility of conducting a larger trial)
timeFrame: 6-month followup to 12-month followup
measure: Change in the adoption of practices learned in the training intervention at 12-month followup
timeFrame: 6-month to 12-month followup
measure: Electronic monitoring of training intervention (adoption of training intervention)
timeFrame: up to the 12-month followup
Secondary outcomes:
measure: Client behavioral engagement by session participation
timeFrame: Weekly from pre-intervention to 12 months after training intervention completion
measure: Client behavioral engagement by session attendance
timeFrame: Weekly from pre-intervention to 12 months after training intervention completion
measure: Therapeutic Alliance Quality Scale (client satisfaction & attitudinal engagement)
timeFrame: Weekly from pre-intervention to 12-month follow up
measure: Service Satisfaction Scale (client satisfaction & attitudinal engagement)
timeFrame: Every other week from pre-intervention to 12-month follow up
measure: Treatment Outcomes Expectation Scale (client satisfaction & attitudinal engagement)
timeFrame: At baseline
measure: Treatment Process Expectations Index (client satisfaction & attitudinal engagement)
timeFrame: At baseline
measure: Ohio Functioning Scale (client functioning)
timeFrame: Monthly from pre-intervention to 12-month follow up
measure: Symptoms and Functionality Severity Scale (client symptomatology & functioning)
timeFrame: Monthly from pre-intervention to 12-month follow up
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Boston College
state: Massachusetts
Study officials:
affiliation: Boston College School of Social Work
name: Maggi Price, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.