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Mise en œuvre axée sur l'équipe dans les centres de défense des enfants

4 octobre 2026 mis à jour par: Elizabeth McGuier, University of Pittsburgh

Mise en œuvre du modèle de processus de soins pour le stress traumatique pédiatrique dans les centres de défense des droits des enfants en milieu rural : un test pilote de mise en œuvre axée sur l'équipe

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

147

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • University of Pittsburgh

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Mise en œuvre centrée sur l'équipe
Comportemental: 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.
Comparateur actif: Implémentation standard
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure
Délai: 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).
Month 6
Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure
Délai: 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).
Month 12
Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure
Délai: 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).
Month 6
Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure
Délai: 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).
Month 12
Feasibility of Team-focused Implementation Assessed by the Feasibility of Intervention Measure
Délai: 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).
Month 6
Feasibility of Team-focused Implementation Assessed by the Feasibility of Intervention Measure
Délai: 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).
Month 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Team Functioning (Learning Behavior) From Baseline to 6-month Follow-up
Délai: 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).

Learning behavior was assessed with 3 items.
Baseline, month 6
Change in Team Functioning (Learning Behavior) From Baseline to 12-month Follow-up
Délai: 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).

Learning behavior was assessed with 3 items.
Baseline, month 12
Change in Team Performance From Baseline to 6- and 12-month Follow-up
Délai: Baseline, month 6, month 12

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).
Baseline, month 6, month 12
CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
Délai: 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).
Month 6
CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
Délai: 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).
Month 12
CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
Délai: 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).
Month 6
CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
Délai: 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).
Month 12
CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
Délai: 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).
Month 6
CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
Délai: 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).
Month 12
CPM-PTS Adoption
Délai: 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.
From start of the study for up to 12 months after CPM-PTS implementation
CPM-PTS Reach
Délai: Monthly for 9 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%). 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).
Monthly for 9 months after CPM-PTS implementation

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Caregiver Understanding of Mental Health Needs
Délai: 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.
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
Délai: 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.
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Pittsburgh

Collaborateurs

National Institute of Mental Health (NIMH)

Les enquêteurs

  • Chercheur principal: Elizabeth McGuier, PhD, University of Pittsburgh

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 juillet 2024

Achèvement primaire (Réel)

8 octobre 2025

Achèvement de l'étude (Réel)

8 octobre 2025

Dates d'inscription aux études

Première soumission

15 décembre 2022

Première soumission répondant aux critères de contrôle qualité

9 janvier 2023

Première publication (Réel)

10 janvier 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • STUDY21010070
  • K23MH123729 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

Data will be available after manuscripts reporting the main findings are accepted for publication.

Critères d'accès au partage IPD

Contact the principal investigator to request access to the deidentified data.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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