Team-Focused Implementation in Child Advocacy Centers

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05679154
Collaborator
National Institute of Mental Health (NIMH) (NIH)
140
1
2
19
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Team-focused Implementation
  • Behavioral: Standard Implementation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The trial includes two groups: team-focused implementation and standard implementation (comparison group).The trial includes two groups: team-focused implementation and standard implementation (comparison group).
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Implementation of the Care Process Model for Pediatric Traumatic Stress in Rural Child Advocacy Centers: A Pilot Test of Team-focused Implementation
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Team-focused Implementation

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.

Active Comparator: Standard Implementation

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure [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).

  2. Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure [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).

  3. Acceptability of team-focused implementation assessed by the Acceptability of Intervention Measure [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).

  4. Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure [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).

  5. Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure [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).

  6. Appropriateness of team-focused implementation assessed by the Intervention Appropriateness Measure [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).

  7. Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure [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).

  8. Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure [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).

  9. Feasibility of team-focused implementation assessed by the Feasibility of Intervention Measure [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).

Secondary Outcome Measures

  1. Change in team functioning from baseline to 6-month follow-up [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).

  2. Change in team functioning from baseline to 12-month follow-up [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).

  3. Change in team performance from baseline to 6- and 12-month follow-up [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).

  4. CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure [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).

  5. CPM-PTS Acceptability assessed by the Acceptability of Intervention Measure [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).

  6. CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure [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).

  7. CPM-PTS Appropriateness assessed by the Intervention Appropriateness Measure [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).

  8. CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure [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).

  9. CPM-PTS Feasibility assessed by the Feasibility of Intervention Measure [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).

  10. CPM-PTS Adoption [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.

  11. CPM-PTS Reach [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%).

Other Outcome Measures

  1. 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)]

    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.

  2. 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)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Elizabeth McGuier, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth McGuier, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05679154
Other Study ID Numbers:
  • STUDY21010070
  • K23MH123729
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elizabeth McGuier, Assistant Professor, University of Pittsburgh

Study Results

No Results Posted as of Jan 10, 2023