Mental Health IssueNCT05679154

Team-Focused Implementation in Child Advocacy Centers

A study testing Team-focused Implementation and Standard Implementation in people with Mental Health Issue and Teamwork, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Mental Health Issue, Teamwork
What is being tested?: Team-focused Implementation and Standard Implementation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2024to 8 Oct 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Under 18 years old.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Mental Health Issue, Teamwork
Being tested: Team-focused Implementation, Standard Implementation
Keywords: Mental health screening, Implementation, Teamwork

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Team-focused ImplementationBehavioural
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 ImplementationBehavioural
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.

Study groups in NCT05679154
Study group	Role	What they receive
Team-focused Implementation	Experimental	Not described Receives: Behavioral: Team-focused Implementation
Standard Implementation	Active comparator	Not described Receives: Behavioral: Standard Implementation

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Month 12

Secondary outcomes (11)

Change in Team Functioning (Learning Behavior) 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).
Learning behavior was assessed with 3 items.
Measured: Baseline, month 6
Change in Team Functioning (Learning Behavior) 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).
Learning behavior was assessed with 3 items.
Measured: Baseline, month 12
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 4 items rated on a 5-point Likert scale. Scores will be averaged; higher scores indicate better performance (range 1-5).
Measured: Baseline, month 6, month 12
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).
Measured: Month 6
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).
Measured: Month 12
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).
Measured: Month 6
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).
Measured: Month 12
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).
Measured: Month 6
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).
Measured: Month 12
CPM-PTS Adoption
Adoption will be indicated by the number of days from training to the first completed screening.
Measured: From start of the study for up to 12 months after CPM-PTS implementation
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%). Reported below are the average monthly screening rate over 9 months (all available data) and the average quarterly screening rate across 3 quarters (all available data).
Measured: Monthly for 9 months after CPM-PTS implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 20248 Oct 2025

First posted10 Jan 2023
Study start31 Jul 2024
Primary completion8 Oct 2025
Study completion8 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mental Health IssueStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: The trial includes two groups: team-focused implementation and standard implementation (comparison group).
Masking: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05679154
Sponsor's protocol ID: STUDY21010070
Other IDs: K23MH123729
Status last verified: Oct 2026
First submitted: 15 Dec 2022
Last updated: 6 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.

Publications

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.
PubMed 37237302

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of the Care Process Model for Pediatric Traumatic Stress in Rural Child Advocacy Centers: A Pilot Test of Team-focused Implementation
ClinicalTrials.gov ID: NCT05679154
Acronym / sponsor ID: STUDY21010070
Conditions: Mental Health Issue, Teamwork
Keywords: Mental health screening, Implementation, Teamwork
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 31 Jul 2024 (actual)
Primary completion: 8 Oct 2025 (actual)
Study completion: 8 Oct 2025 (actual)
First posted: 10 Jan 2023 (actual)
Results: Posted 6 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The trial includes two groups: team-focused implementation and standard implementation (comparison group).

Arm	Type	Receives
Team-focused Implementation	Experimental	Behavioral: Team-focused Implementation
Standard Implementation	Active comparator	Behavioral: Standard Implementation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Under 18 years old.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Team-focused ImplementationCACs 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.	Behavioural	Team-focused Implementation
Standard ImplementationCACs 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.	Behavioural	Standard Implementation

Primary outcome

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).
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).
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).
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).
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).
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).

11 secondary outcomes

Change in Team Functioning (Learning Behavior) From Baseline to 6-month Follow-up
Time frame: Baseline, month 6
Change in Team Functioning (Learning Behavior) From Baseline to 12-month Follow-up
Time frame: Baseline, month 12
Change in Team Performance From Baseline to 6- and 12-month Follow-up
Time frame: Baseline, month 6, month 12
CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
Time frame: Month 6
CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
Time frame: Month 12
CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
Time frame: Month 6
CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
Time frame: Month 12
CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
Time frame: Month 6
CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
Time frame: Month 12
CPM-PTS Adoption
Time frame: From start of the study for up to 12 months after CPM-PTS implementation
CPM-PTS Reach
Time frame: Monthly for 9 months after CPM-PTS implementation

Results and safety

Results posted to the registry on 6 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Team-focused Implementation	49	34
Standard Implementation	37	26
Withdrew Before Randomization	55	0

Primary outcome: Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure

Time frame: Month 6. Mean (Standard Deviation). Unit: Score on scale

Measure	Team-focused Implementation n = 43	Standard Implementation n = 0
Value	4.31 (0.69)	–

Population analysed: Only participants in the team-focused implementation condition rated its acceptability. Analyses included participants with complete data for this measure.

Primary outcome: Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure

Time frame: Month 12. Mean (Standard Deviation). Unit: Score on scale

Measure	Team-focused Implementation n = 38	Standard Implementation n = 0
Value	4.34 (0.53)	–

Population analysed: Only participants in the team-focused implementation condition rated its acceptability. Analyses included participants with complete data for this measure.

Primary outcome: Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure

Time frame: Month 6. Mean (Standard Deviation). Unit: Score on scale

Measure	Team-focused Implementation n = 43	Standard Implementation n = 0
Value	4.34 (0.64)	–

Population analysed: Only participants in the team-focused implementation condition rated its appropriateness. Analyses included participants with complete data for this measure.

Primary outcome: Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure

Time frame: Month 12. Mean (Standard Deviation). Unit: Score on scale

Measure	Team-focused Implementation n = 38	Standard Implementation n = 0
Value	4.38 (0.54)	–

Population analysed: Only participants in the team-focused implementation condition rated its appropriateness. Analyses included participants with complete data for this measure.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment to end of participation, up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Team-focused Implementation	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Standard Implementation	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37237302McGuier 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.
Individual participant dataSharing planned: Yes. Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth McGuier, PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Team-focused Implementation and Standard Implementation in people with Mental Health Issue and Teamwork, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure (time frame: Month 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05679154, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.