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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
286
The training intervention is a modular online asynchronous training intervention designed to increase mental health providers' use of evidence-based practices with youth patients (ages 12-25). It was developed using community-engaged and human-centered design methods with key stakeholders (youth, their parents, mental health providers). In this open trial, the training will be offered to mental health providers at a multisite mental health clinic in the U.S. (referred to as "pilot site" herein).
Boston College
Chestnut Hill, Massachusetts, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. 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)
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Time frame: Baseline, Post-training, 6-month to 12-month followup
Electronic Monitoring of Training Intervention Completion (Adoption of Training Intervention)
Electronic monitoring of training intervention completion by providers (i.e., whether all modules were completed).
Time frame: up to the 12-month followup
Primary Outcome: Electronic Monitoring of Training Intervention Engagement (Adoption of Training Intervention)
Electronic monitoring of training intervention engagement (e.g., days spent completing the training)
Time frame: up to the 12-month followup
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 electronic health record monitoring of treatment measures completion (e.g., answering all questions and submitting measures related to client treatment, such as the TAQs).
Time frame: 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. Outcomes report the total number of GMY participants who attended therapy during the timeframe
Time frame: 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. Outcomes report pre-intervention TAQs score (i.e., first instance of participant completing TAQs prior-to intervention) and 12-month follow-up TAQs score.
Time frame: 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. Outcomes report pre-intervention SSS score (i.e., first instance of participant completing SSS prior-to intervention) and 12-month follow-up SSS score.
Time frame: 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.
Time frame: Pre-intervention
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 (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.
Time frame: Pre-intervention
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"). 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.
Time frame: 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"). 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.
Time frame: Monthly from pre-intervention to 12-month follow up