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Knowledge, Attitudes, PracticeNCT05626231

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

A study testing Training Intervention in people with Knowledge, Attitudes, Practice, run by Boston College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Knowledge, Attitudes, Practice
What is being tested?
Training Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
1 siteUnited States
Study dates
1 Sep 2022to 31 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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

Who cannot join

  • Provided that participants meet the aforementioned inclusion criteria, there are no explicit criteria for exclusion.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston College

    Chestnut Hill, Massachusetts, 02467

Other trials in United States

About this study

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).

Read the 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).

Being tested
Training Intervention
Keywords
youth, child, adolescent, young adult, psychologist, social worker, psychiatrist, counselor, teen, provider, therapist, clinician
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training InterventionBehavioural

    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).

Study groups in NCT05626231
Study groupRoleWhat they receive
Training InterventionExperimentalThe single-arm intervention study will test an online asynchronous evidence-based practices training intervention.
Receives: Behavioral: Training Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At time of training intervention

  2. 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.

    Measured: Pre-training to post-training (up to 4 weeks after the training)

  3. 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.

    Measured: Post-training (up to 4 weeks after the training) to 6-month followup

  4. 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.

    Measured: 6-month followup to 12-month followup

  5. 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)

    Measured: Baseline, Post-training, 6-month to 12-month followup

  6. 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).

    Measured: up to the 12-month followup

  7. 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)

    Measured: up to the 12-month followup

Secondary outcomes (8)

  1. 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).

    Measured: Weekly from pre-intervention to 12 months after training intervention completion

  2. 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

    Measured: Weekly from pre-intervention to 12 months after training intervention completion

  3. 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.

    Measured: Weekly from pre-intervention to 12-month follow up

  4. 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.

    Measured: Every other week from pre-intervention to 12-month follow up

  5. 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.

    Measured: Pre-intervention

  6. 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.

    Measured: Pre-intervention

  7. 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.

    Measured: Monthly from pre-intervention to 12-month follow up

  8. 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.

    Measured: Monthly from pre-intervention to 12-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
The single-arm intervention will test an online, asynchronous training intervention.
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626231
Sponsor's protocol ID
Training Development Study
Other IDs
K23MH124670
Status last verified
Sep 2025
First submitted
1 Nov 2022
Last updated
25 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bidell MP. The Sexual Orientation Counselor Competency Scale: Assessing attitudes, skills, and knowledge of counselors working with lesbian, gay, and bisexual clients. Counselor Education and Supervision. 2011; 44(4): 267-279.

  • 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.

    PubMed 35901370

  • Athay MM, Bickman L. Development and psychometric evaluation of the youth and caregiver Service Satisfaction Scale. Adm Policy Ment Health. 2012 Mar;39(1-2):71-7. doi: 10.1007/s10488-012-0407-y.

    PubMed 22407558

  • Duppong Hurley K, Lambert MC, Van Ryzin M, Sullivan J, Stevens A. Therapeutic Alliance Between Youth and Staff in Residential Group Care: Psychometrics of the Therapeutic Alliance Quality Scale. Child Youth Serv Rev. 2013 Jan 1;35(1):56-64. doi: 10.1016/j.childyouth.2012.10.009. Epub 2012 Nov 8.

    PubMed 23264715

  • Bickman L, Kelley SD, Breda C, de Andrade AR, Riemer M. Effects of routine feedback to clinicians on mental health outcomes of youths: results of a randomized trial. Psychiatr Serv. 2011 Dec;62(12):1423-9. doi: 10.1176/appi.ps.002052011.

    PubMed 22193788

  • 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.

    PubMed 25876736

  • Price MA, Mulkern PJ, Condon M, Rakhilin M, Johansen K, Lyon AR, Saldana L, Pachankis J, Woodward SA, Roeder KM, Moran LR, Jerskey BA. Leveraging community engagement and human-centered design to develop multilevel implementation strategies to enhance adoption of a health equity intervention. Implement Sci Commun. 2025 Nov 24;6(1):130. doi: 10.1186/s43058-025-00809-7.

    PubMed 41287012

  • Price MA, Mulkern PJ, Condon M, Rakhilin M, Johansen K, Lyon AR, Saldana L, Pachankis J, Woodward SA, Roeder KM, Moran LR, Jerskey BA. Leveraging Community Engagement and Human-Centered Design to Develop Multilevel Implementation Strategies to Enhance Adoption of a Health Equity Intervention. Res Sq [Preprint]. 2025 Mar 28:rs.3.rs-5702080. doi: 10.21203/rs.3.rs-5702080/v1.

    PubMed 40195981

Questions about this trial

What is this clinical trial studying?

A study testing Training Intervention in people with Knowledge, Attitudes, Practice, run by Boston College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Provider Participant Recruitment Rates (Feasibility of Conducting a Larger Trial) (time frame: At time of training intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626231, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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