Development of a Training Intervention to Improve Mental Health Treatment Effectiveness and Engagement for Youth With Documented Mental Health Disparities
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Sponsor: Boston College

September 2, 2025 
 
Study Title:  
Development of a Training Intervention to Improve Mental Health Treatment 
Effectiveness and Engagement for Youth with Documented Mental Health Disparities  
Clinical Trials Number 
NCT05626231 
 
Principal Investigator 
Dr. Maggi Price  
Boston College School of social work  
 

September 2, 2025 
Research Summary: 
Specific Aims/Study Objective: 
Pilot the training intervention in a non-specialty mental health care setting. An open trial 
with mental health providers (N = 44) treating gender-minority youth (youth patients) 
patients across multiple U.S. clinics will be conducted to examine the feasibility and 
acceptability of conducting a future RCT. During the intervention, data on the utilization 
of online materials (e.g., time spent in each module), survey data, answers to 
short-answer questions, and intervention acceptability data will be collected. In line with 
NIMH’s emphasis on the efficient deployment of effective and solution-oriented 
interventions, follow-up assessments will collect data on the primary outcome (i.e., 
providers’ use of evidence-based practices (EBP) and implementation data (e.g., 
barriers to adoption). Data on hypothesized mechanisms (knowledge, attitudes, 
self-efficacy) will be collected immediately before and after the training intervention, as 
well as 3, 6 and 12 months later. Additionally, providers will complete a brief monthly 
assessment . To explore potential training intervention-related changes in patient 
engagement and symptomatology (distal outcomes), chart data (e.g., treatment 
attendance) and weekly and quarterly survey data (e.g., treatment satisfaction, 
internalizing problems) from youth patients and their parents will be collected and 
analyzed. Additionally, up to patients and parents will be invited to complete 2 surveys , 
at 16 time points beginning 2 weeks before the training begins. Provider-level 
implementation data (e.g.,acceptability, appropriateness, feasibility) will be used to 
refine the intervention for larger-scale testing. To reduce participant burden, those who 
have not responded to any survey or reminder emails/texts in three weeks will have the 
opportunity to opt out of receiving further surveys or reminders. Participants who 
completed surveys and consented to future studies will be invited to participate in a 
1-hour follow-up assessment, with 45 minutes dedicated to a semi-structured qualitative 
interview and 15 minutes dedicated to surveys. 
Materials, Methods, and Analysis: 
The open trial will be conducted in a multi-site mental mental health care agency 
specializing in EBP for youth and families. At the anticipated time of the open trial, the 
clinic expects to employ 52 providers. 
Training intervention procedures. The partner agency uses a HIPAA-compliant video 
conferencing service for telehealth, remote training, and supervision. Thus, they have 
the capacity to engage all of their multi-site clinicians simultaneously in online training. 
All providers will be compensated for follow-up assessments, but not for training 
completion, in order to maximize external validity.  
Measurement and Assessment. Provider assessments: Though participation in the 
training will be required of all partner agency providers, assessments will be voluntary. 
During the intervention, data on the utilization of online materials (e.g., time spent in 
each module),  survey data, answers to short-answer questions, and intervention 
acceptability data  will be collected. Pre-, post-, monthly assessments following training 

September 2, 2025 
completion, and 3-month, 6-month, and 12-month follow-up assessments will be 
conducted for those who consent to study participation, and will focus on both 
implementation and service outcomes (measures described below). All quantitative and 
written qualitative data will be collected electronically Qualtrics. Additionally, a small 
number of non-partner agency providers may complete the training and may also 
complete the assessments.  Patient outcomes: To explore potential intervention-related 
changes in patient engagement and mental health (i.e., preliminary effectiveness), chart 
and survey data will be analyzed. The partner agency has multiple ongoing research 
partnerships, and thus the agency-wide informed consent for treatment requires all 
patients to agree to have their deidentified data used for research purposes. For the 
proposed study, the partner agency will share their (1) comprehensive chart data and 
(2) intake assessment and treatment-specific survey data administered in routine 
practice for all patients ages 12-25. Patients currently complete surveys at home on an 
electronic device. The partner agency has also agreed to administer additional patient 
measures. as soon as IRB approval has been secured. The research team will also 
administer a separate survey to participating patients and patients’ parents about their 
provider’s use of evidence-based practices and their mental health. 
Materials or tools used to collect the data:  
Provider assessments: Though participation in the training will be required of all partner 
agency providers, assessments will be voluntary. Non-partner agency providers who 
take the training may also voluntarily take assessments. Pre-, post-, monthly 
assessments following training completion, and 3-month, 6-month, and 12-month 
follow-up assessments will be conducted for those who consent to study participation, 
and will focus on both implementation and service outcomes. All quantitative and written 
qualitative data will be collected electronically through Qualtrics. Baseline measures will 
assess demographics (e.g., age, race), background and previous training data and 
knowledge .  
Additionally, data on the utilization of online materials (e.g., time spent in each module), 
answers to short-answer questions, and intervention acceptability data  will be collected. 
Patient outcomes: To explore potential intervention-related changes in patient 
engagement and mental health (i.e., preliminary effectiveness), chart and survey data 
will be analyzed. The partner agency has multiple ongoing research partnerships, and 
thus the agency-wide informed consent for treatment requires all patients to agree to 
have their deidentified data used for research purposes. For the proposed study, the 
partner agency will share their (1) comprehensive chart data (e.g., demographics, 
diagnoses, treatment) and (2) intake assessment and treatment-specific survey data 
administered in routine practice for all patients ages 12-25. The PI initiated the DUA 
process between the partner agency and BC on 6/9/2021 and finalized the DUA on 
9/13/2022. Patients currently complete surveys at home on an electronic device. The 
partner agency has also agreed to administer and share additional patient measures. 

September 2, 2025 
During follow up assessments, participants will be interviewed using a semi-structured 
interview protocol. Minor adaptations will be made to be each participant’s protocol 
based on their previous survey responses. 
Patient measure details: Deidentified chart and survey data from the partner agency will 
be analyzed to examine the effects of the training intervention on patient outcomes. 
Primary outcomes are (1) treatment engagement and (2) mental and behavioral health. 
Treatment engagement will be measured using both behavioral (i.e., retention) data and 
attitudinal data. Behavioral engagement data will be derived from the partner agency 
chart data, including the number of sessions attended, session participants (e.g.,youth 
patients only, parent-youth patient), number of sessions canceled and no-showed, and 
reason for termination. Attitudinal engagement data will be measured via two self-report 
surveys administered separately to youth patients and parents throughout the duration 
of the open trial at 16 time points. Mental and behavioral health will be assessed 
through quarterly and weekly measures, each separately administered to youth patients 
and parents. Finally, in line with best practices in patient exit interviews (Beehler et al., 
2009; Hrisos et al., 2009), we will develop a brief survey (e.g., 19 items) asking youth 
patients and (separately) their parents to indicate whether or not their provider used key 
evidence-based practices during their most recent session. During the pilot trial, youth 
patients and parents will complete this brief measure along with the other surveys 
administered weekly by the partner agency. 
 

September 2, 2025 
Statistical analysis 
Hypotheses: The primary purpose of the open trial pilot is to test the methods and 
procedures to be used in a larger trial. More specifically, the acceptability and feasibility 
of the training intervention, as well as the feasibility of a larger trial, will be explored. In 
order to determine the effect sizes necessary to power a full trial, several intervention 
hypotheses will be examined. Regarding the provider outcomes, I hypothesize that: 
(H1) trained providers will use more evidence-based practices after training and at 
follow-up assessments compared to before training, and (H2) this change will be 
mediated by the three mechanisms (knowledge, attitudes, self-efficacy). Regarding 
patient outcomes, I hypothesize that (H3) compared to pre-intervention time points, 
levels of treatment engagement will be higher after the intervention and (H4) the 
trajectory of mental health symptom reduction will improve (i.e., become steeper). In 
addition, (H5) patient changes will be specific to youth patient participants, such that 
youth patient participants at the partner agency do not evidence intervention-related 
changes. 
Analyses: Feasibility and acceptability of conducting a future RCT will be assessed by 
reporting summary statistics on relevant variables. All acceptability statistics will be 
benchmarked against similar trials of provider-trainings previously conducted by the 
research team (Lelutiu-Weinberger & Pachankis, 2017; Lelutiu-Weinberger et al., 2016). 
The preliminary effectiveness (H1, H3, H4) of the intervention will be assessed by 
examining trajectories of change in provider- and patient-outcomes through hierarchical 
linear modeling (HLM), which is recommended by the IOM for obtaining valid and 
reliable results from small clinical trials (Institute of Medicine, 2001). HLM is robust to 
ignorably missing data and thus allows for the inclusion of participants who do not 
complete all assessments (e.g., due to attrition; McCartney et al., 2006; Singer & Willett, 
2003). To examine mechanisms (H2), the Bayesian method (Koopman et al., 2015) will 
be used, as it has been recommended and validated for this purpose in small samples 
(N = 20-80). To examine the specificity of intervention effects (H5), data from all the 
partner agency patients will be analyzed in multi-group analyses examining potential 
outcome differences across non-youth patient participants  
and youth patient 
participants. Successful implementation will be assessed using mixed methods data 
from providers. Consistent with several qualitative provider-focused implementation 
studies (Distel et al., 2019; Hamm et al., 2015; Stein et al., 2010; Stirman et al., 2013), 
qualitative content analysis (Schreier, 2012) will be used to analyze written and 
interview data from providers. Recommended practices for mixed methods 
implementation science research will also be utilized (Palinkas et al., 2011). For 
example, triangulation will assess the convergence of themes from interview data and 
responses on the survey of evidence-based practice utilization. ChatGPT 4.0 will be 
used to assist in analyzing data from providers, youth, and parents. All data will be 
completely de-identified before entering the ChatGPT 4.0 system.  These analyses will 
shed light on providers’ long-term experiences implementing evidence-based practices 
(e.g., barriers and facilitators to adoption) and have direct implications for protocol 
refinement.