Development of a Training Intervention to Improve Mental Health Treatment Effectiveness and Engagement for Youth With Documented Mental Health Disparities

Not Applicable

Completed

Conditions: Knowledge, Attitudes, Practice

Registration Number: NCT05626231

Lead Sponsor: 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 evidence-based practices with youth patients. 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 evidence-based practices with youth patients. 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, youth patients, and parents. 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 patients (i.e., youth and their parents; 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., patients and their parents).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 286

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.
Age 12-25
Currently receiving mental health services from the pilot site
Fluent in English

For parents of youth participants:

Parents of youth 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Provider Participant Recruitment Rates (Feasibility of Conducting a Larger Trial)	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.
Change in Provider Participant Assessment Completion Rates at Post-training (Feasibility of Conducting a Larger Trial)	Pre-training to post-training (up to 4 weeks after the training)	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.
Change in Provider Participant Assessment Completion Rates at 6-month Followup (Feasibility of Conducting a Larger Trial)	Post-training (up to 4 weeks after the training) to 6-month followup	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.
Change in Provider Participant Assessment Completion Rates at 12-month Followup (Feasibility of Conducting a Larger Trial)	6-month followup to 12-month followup	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.
Change in the Adoption of Practices Learned in the Training Intervention at 12-month Followup	Baseline, Post-training, 6-month to 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. Scores are calculated using mean scores for values 0-4 with higher numbers indicating more of the use of the practice (i.e., (0) Not at all, (4) Very much)
Electronic Monitoring of Training Intervention Completion (Adoption of Training Intervention)	up to the 12-month followup	Electronic monitoring of training intervention completion by providers (i.e., whether all modules were completed).
Primary Outcome: Electronic Monitoring of Training Intervention Engagement (Adoption of Training Intervention)	up to the 12-month followup	Electronic monitoring of training intervention engagement (e.g., days spent completing the training)

Secondary Outcome Measures

Name	Time	Method
Ohio Functioning Scale (Client Functioning)	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"). A total functioning score ranges from 20-100 and is calculated by summing the ratings for all 20 items. Higher scores are indicative of better functioning. The Ohio Functioning Scale will be administered to clients aged 12-25 and caregivers. Outcomes report pre-intervention Ohio score (i.e., first instance of participant completing Ohio prior-to intervention) and 12-month follow-up Ohio score.
Client Behavioral Engagement by Session Participation	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 electronic health record monitoring of treatment measures completion (e.g., answering all questions and submitting measures related to client treatment, such as the TAQs).
Client Behavioral Engagement by Session Attendance	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. Outcomes report the total number of GMY participants who attended therapy during the timeframe
Therapeutic Alliance Quality Scale (Client Satisfaction & Attitudinal Engagement)	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. Outcomes report pre-intervention TAQs score (i.e., first instance of participant completing TAQs prior-to intervention) and 12-month follow-up TAQs score.
Service Satisfaction Scale (Client Satisfaction & Attitudinal Engagement)	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. Outcomes report pre-intervention SSS score (i.e., first instance of participant completing SSS prior-to intervention) and 12-month follow-up SSS score.
Treatment Outcomes Expectation Scale (Client Satisfaction & Attitudinal Engagement)	Pre-intervention	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)	Pre-intervention	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 (e.g., 1= "I do not expect this," 2= "I am not sure", and 3= "I do expect this"). There is no right or wrong answer. The reported scores should be interpreted at the item level to identify clinical suggestions for providers based on the clients reported expectations at baseline. The TPEI will be administered to clients aged 12-25 and caregivers.
Symptoms and Functionality Severity Scale (Client Symptomatology & Functioning)	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"). Scores can range from 33 to 86 for youths, where a high score represents high severity and a low score indicates low severity. Total scores are calculated by adding the rating and then divide the sum by the number of items to calculate the average score.The SFSS will be administered to clients aged 12-25 and caregivers. Outcomes report pre-intervention SFSS score (i.e., first instance of participant completing SFSS prior-to intervention) and 12-month follow-up SFSS score.