NCT05626231

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
25 days until next milestone

Results Posted

Study results publicly available

September 25, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

November 1, 2022

Results QC Date

July 28, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

youthchildadolescentyoung adultpsychologistsocial workerpsychiatristcounselorteenprovidertherapistclinician

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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)

    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).

    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)

    up to the 12-month followup

Secondary Outcomes (8)

  • Client Behavioral Engagement by Session Participation

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

  • Client Behavioral Engagement by Session Attendance

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

  • Therapeutic Alliance Quality Scale (Client Satisfaction & Attitudinal Engagement)

    Weekly from pre-intervention to 12-month follow up

  • Service Satisfaction Scale (Client Satisfaction & Attitudinal Engagement)

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

  • Treatment Outcomes Expectation Scale (Client Satisfaction & Attitudinal Engagement)

    Pre-intervention

  • +3 more secondary outcomes

Study Arms (1)

Training Intervention

EXPERIMENTAL

The single-arm intervention study will test an online asynchronous evidence-based practices training intervention.

Behavioral: Training Intervention

Interventions

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).

Training Intervention

Eligibility Criteria

Age12 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsYouth participants will have gender-based inclusion criteria. The youth must identify as a gender-minority.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • or older
  • Fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston College

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (8)

  • 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.

    BACKGROUND
  • 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.

    PMID: 35901370BACKGROUND
  • 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.

    PMID: 22407558BACKGROUND
  • 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.

    PMID: 23264715BACKGROUND
  • 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.

    PMID: 22193788BACKGROUND
  • 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.

    PMID: 25876736BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Behavior

Limitations and Caveats

The primary pilot site changed EHR systems in May 2024, which was near the end of our EHR-data-collection period for this study (18 months; spanning November 2022 to July 2024). Because of this, patients did not complete any surveys in May 2024. We used best statistical practices for handling systematically missing data during data analysis (e.g., multiple imputation). We will also report this missingness in any publication of pilot results involving these data.

Results Point of Contact

Title
Dr. Maggi Price, PI
Organization
Boston College School of Social Work

Study Officials

  • Maggi Price, PhD

    Boston College School of Social Work

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The single-arm intervention will test an online, asynchronous training intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 23, 2022

Study Start

September 1, 2022

Primary Completion

July 31, 2024

Study Completion

August 31, 2025

Last Updated

September 25, 2025

Results First Posted

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations