NCT05679154

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

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

First Submitted

Initial submission to the registry

December 15, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

December 15, 2022

Last Update Submit

October 24, 2025

Conditions

Keywords

Mental health screeningImplementationTeamwork

Outcome Measures

Primary Outcomes (9)

  • Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (11)

  • Change in team functioning from baseline to 6-month follow-up

    Baseline, month 6

  • Change in team functioning from baseline to 12-month follow-up

    Baseline, month 12

  • Change in team performance from baseline to 6- and 12-month follow-up

    Baseline, month 6, month 12

  • CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure

    Month 6

  • CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure

    Month 12

  • +6 more secondary outcomes

Other Outcomes (2)

  • Caregiver understanding of child mental health needs

    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

    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)

Study Arms (2)

Team-focused Implementation

EXPERIMENTAL
Behavioral: Team-focused Implementation

Standard Implementation

ACTIVE COMPARATOR
Behavioral: Standard Implementation

Interventions

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.

Team-focused 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.

Standard Implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals at least 18 years of age who are members of the multidisciplinary team at the participating CACs.

You may not qualify if:

  • Under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • McGuier EA, Aarons GA, Wright JD, Fortney JC, Powell BJ, Rothenberger SD, Weingart LR, Miller E, Kolko DJ. Team-focused implementation strategies to improve implementation of mental health screening and referral in rural Children's Advocacy Centers: study protocol for a pilot cluster randomized hybrid type 2 trial. Implement Sci Commun. 2023 May 26;4(1):58. doi: 10.1186/s43058-023-00437-z.

Study Officials

  • Elizabeth McGuier, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The trial includes two groups: team-focused implementation and standard implementation (comparison group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 10, 2023

Study Start

July 31, 2024

Primary Completion

October 8, 2025

Study Completion

October 8, 2025

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be available after manuscripts reporting the main findings are accepted for publication.
Access Criteria
Contact the principal investigator to request access to the deidentified data.

Locations