Team-Focused Implementation in Child Advocacy Centers

Mental Health Issue Clinical Trial

Official title:

Implementation of the Care Process Model for Pediatric Traumatic Stress in Rural Child Advocacy Centers: A Pilot Test of Team-focused Implementation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05679154
• Other study ID #: STUDY21010070
• Secondary ID: K23MH123729
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Elizabeth McGuier, PhD
• Phone: 412-246-5895
• Email: millerea3[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver understanding of child mental health needs	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)
Other	Caregiver intention to initiate mental health services	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in team functioning from baseline to 6-month follow-up	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
Secondary	Change in team functioning from baseline to 12-month follow-up	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
Secondary	Change in team performance from baseline to 6- and 12-month follow-up	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
Secondary	CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure	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
Secondary	CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure	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
Secondary	CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure	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
Secondary	CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure	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
Secondary	CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure	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
Secondary	CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure	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
Secondary	CPM-PTS Adoption	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
Secondary	CPM-PTS Reach	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