- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679154
Team-Focused Implementation in Child Advocacy Centers
October 24, 2025 updated by: Elizabeth McGuier, University of Pittsburgh
Implementation of the Care Process Model for Pediatric Traumatic Stress in Rural Child Advocacy Centers: A Pilot Test of Team-focused Implementation
Child Advocacy Centers (CACs) are well-positioned to identify children at risk for mental health problems and to facilitate access to evidence-based treatments.
Implementation of standardized mental health screening and referral protocols may improve recognition of mental health needs and facilitate treatment engagement.
Implementation strategies that improve teamwork may enhance implementation outcomes in team-based settings like CACs.
In this study, CACs will implement the Care Process Model for Pediatric Traumatic Stress (CPM-PTS) and be randomized to either team-focused implementation or standard implementation.
The study aims are to evaluate the feasibility of team-focused implementation and the effect of the CPM-PTS on caregiver understanding of mental health needs and intentions to initiate treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a pilot cluster randomized controlled hybrid Type II effectiveness-implementation trial in 4 rural Child Advocacy Centers.
All CACs will implement the Care Process Model for Pediatric Traumatic Stress (CPM-PTS), a mental health screening and referral protocol.
CACs will be randomized to team-focused implementation (n = 2) or standard implementation (n = 2).
The study is designed to evaluate the acceptability, appropriateness, and feasibility of team-focused implementation strategies.
It will also test the effect of the CPM-PTS on caregiver understanding of mental health needs and intentions to initiate treatment.
Mixed methods will be used to evaluate the feasibility of team-focused implementation, test the effect of team strategies on teamwork, and assess implementation outcomes.
Administrative data collected anonymously from caregivers will be used to test the effectiveness of the CPM-PTS.
Study Type
Interventional
Enrollment (Actual)
147
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals at least 18 years of age who are members of the multidisciplinary team at the participating CACs.
Exclusion Criteria:
- Under 18 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Team-focused Implementation
|
CACs randomized to the experimental condition (n = 2) will participate in team-focused implementation.
They will receive team development interventions (e.g., goal-setting exercise, training in communication skills) integrated with standard CPM-PTS training and technical assistance strategies.
|
|
Active Comparator: Standard Implementation
|
CACs randomized to the comparison condition (n = 2) will receive standard training and technical assistance strategies to support CPM-PTS implementation.
They will receive CPM-PTS materials (e.g., manual, REDCap surveys, referral protocols), an interactive training, and six months of technical assistance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure
Time Frame: Baseline
|
Perceived acceptability of team-focused implementation will be assessed with items from the Acceptability of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Baseline
|
|
Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure
Time Frame: Month 6
|
Perceived acceptability of team-focused implementation will be assessed with items from the Acceptability of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 6
|
|
Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure
Time Frame: Month 12
|
Perceived acceptability of team-focused implementation will be assessed with items from the Acceptability of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 12
|
|
Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure
Time Frame: Baseline
|
Perceived appropriateness of team-focused implementation will be assessed with items from the Intervention Appropriateness Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Baseline
|
|
Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure
Time Frame: Month 6
|
Perceived appropriateness of team-focused implementation will be assessed with items from the Intervention Appropriateness Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 6
|
|
Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure
Time Frame: Month 12
|
Perceived appropriateness of team-focused implementation will be assessed with items from the Intervention Appropriateness Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 12
|
|
Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure
Time Frame: Baseline
|
Perceived feasibility of team-focused implementation will be assessed with items from the Feasibility of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Baseline
|
|
Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure
Time Frame: Month 6
|
Perceived feasibility of team-focused implementation will be assessed with items from the Feasibility of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 6
|
|
Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure
Time Frame: Month 12
|
Perceived feasibility of team-focused implementation will be assessed with items from the Feasibility of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in team functioning from baseline to 6-month follow-up
Time Frame: Baseline, month 6
|
Affective, behavioral, and cognitive processes and states will be assessed with survey items rated on Likert scales.
Scores will be averaged; higher scores indicate more adaptive team functioning (range 1-7).
|
Baseline, month 6
|
|
Change in team functioning from baseline to 12-month follow-up
Time Frame: Baseline, month 12
|
Affective, behavioral, and cognitive processes and states will be assessed with survey items rated on Likert scales.
Scores will be averaged; higher scores indicate more adaptive team functioning (range 1-7).
|
Baseline, month 12
|
|
Change in team performance from baseline to 6- and 12-month follow-up
Time Frame: Baseline, month 6, month 12
|
The overall quality of work done by the team will be assessed with Edmondson's (1999) Team Performance scale (5 items rated on a 7-point Likert scale).
Scores will be averaged; higher scores indicate better performance (range 1-7).
|
Baseline, month 6, month 12
|
|
CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure
Time Frame: Month 6
|
Perceived acceptability of the CPM-PTS will be assessed with items from the Acceptability of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 6
|
|
CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure
Time Frame: Month 12
|
Perceived acceptability of the CPM-PTS will be assessed with items from the Acceptability of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 12
|
|
CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure
Time Frame: Month 6
|
Perceived appropriateness of the CPM-PTS will be assessed with items from the Intervention Appropriateness Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 6
|
|
CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure
Time Frame: Month 12
|
Perceived appropriateness of the CPM-PTS will be assessed with items from the Intervention Appropriateness Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 12
|
|
CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure
Time Frame: Month 6
|
Perceived feasibility of the CPM-PTS will be assessed with items from the Feasibility of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 6
|
|
CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure
Time Frame: Month 12
|
Perceived feasibility of the CPM-PTS will be assessed with items from the Feasibility of Intervention Measure.
Each item is rated on a 1-5 Likert scale.
Scores will be averaged; higher scores indicate more positive perceptions (range 1-5).
|
Month 12
|
|
CPM-PTS Adoption
Time Frame: From start of the study for up to 12 months after CPM-PTS implementation
|
Adoption will be indicated by the number of days from training to the first completed screening.
|
From start of the study for up to 12 months after CPM-PTS implementation
|
|
CPM-PTS Reach
Time Frame: Monthly for 12 months after CPM-PTS implementation
|
Reach will be indicated by screening rates (i.e., completed screenings / eligible children) and calculated for monthly and quarterly periods (possible range 0-100%).
|
Monthly for 12 months after CPM-PTS implementation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver understanding of child mental health needs
Time Frame: Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
Caregivers will rate 1 item assessing their understanding of their child's mental health needs on a 4-point Likert scale (range 1-4) in an anonymous end of visit survey.
|
Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
|
Caregiver intention to initiate mental health services
Time Frame: Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
Caregivers will rate 1 item assessing their intention to initiate mental health services for their child on a 5-point Likert scale (range 1-5) in an anonymous end of visit survey.
|
Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth McGuier, PhD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2024
Primary Completion (Actual)
October 8, 2025
Study Completion (Actual)
October 8, 2025
Study Registration Dates
First Submitted
December 15, 2022
First Submitted That Met QC Criteria
January 9, 2023
First Posted (Actual)
January 10, 2023
Study Record Updates
Last Update Posted (Estimated)
October 28, 2025
Last Update Submitted That Met QC Criteria
October 24, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY21010070
- K23MH123729 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.
IPD Sharing Time Frame
Data will be available after manuscripts reporting the main findings are accepted for publication.
IPD Sharing Access Criteria
Contact the principal investigator to request access to the deidentified data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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