Clinical trial NCT05679154: Team-Focused Implementation in Child Advocacy Centers
Official title: Implementation of the Care Process Model for Pediatric Traumatic Stress in Rural Child Advocacy Centers: a Pilot Test of Team-focused Implementation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mental Health Issue
Teamwork
Keywords: Mental health screening
Implementation
Teamwork
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial includes two groups: team-focused implementation and standard implementation (comparison group).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure
timeFrame: Baseline
measure: Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure
timeFrame: Month 6
measure: Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure
timeFrame: Month 12
measure: Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure
timeFrame: Baseline
measure: Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure
timeFrame: Month 6
measure: Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure
timeFrame: Month 12
measure: Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure
timeFrame: Baseline
measure: Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure
timeFrame: Month 6
measure: Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure
timeFrame: Month 12
Secondary outcomes:
measure: Change in team functioning from baseline to 6-month follow-up
timeFrame: Baseline, month 6
measure: Change in team functioning from baseline to 12-month follow-up
timeFrame: Baseline, month 12
measure: Change in team performance from baseline to 6- and 12-month follow-up
timeFrame: Baseline, month 6, month 12
measure: CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure
timeFrame: Month 6
measure: CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure
timeFrame: Month 12
measure: CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure
timeFrame: Month 6
measure: CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure
timeFrame: Month 12
measure: CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure
timeFrame: Month 6
measure: CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure
timeFrame: Month 12
measure: CPM-PTS Adoption
timeFrame: From start of the study for up to 12 months after CPM-PTS implementation
measure: CPM-PTS Reach
timeFrame: Monthly for 12 months after CPM-PTS implementation
Other outcomes:
measure: Caregiver understanding of child mental health needs
timeFrame: 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)
measure: Caregiver intention to initiate mental health services
timeFrame: 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)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth McGuier, PhD
role: PRINCIPAL_INVESTIGATOR
References: