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Purpose

This study investigates the implementation and effectiveness of the Family Check-Up 4 Health (FCU4Health) intervention in primary care settings for reducing cardiovascular disease risk in children. Through a hybrid type 3 cluster randomized factorial trial and innovative technology-based strategies integrated with Electronic Health Records, the study aims to enhance intervention fidelity and engagement. Results will inform scalable approaches to promote child and family health behaviors, improve parenting skills, and potentially reduce child BMI, contributing to significant public health impacts in addressing cardiovascular health disparities.

Condition

Eligibility

Eligible Ages
Over 2 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • BMI at or above 85 percentile for age and gender.

Exclusion Criteria

  • N/A

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
We will test the hypotheses related to implementation strategies at α=.025 to control the family-wise type I error rate at 0.05: (1) mean difference in fidelity in favor of those randomized to the fidelity support condition (including Lyssn, COACH coding, and group supervision), (2) higher engagement for those randomized to SMS. Each hypothesis will be tested under the framework of a linear mixed-effects model to account for care team, FCU4Health Coordinator, and family-level clustering. In addition to the main, each model will include random effects for care team and Coordinator, and covariates used in the restricted randomization. Updated power analyses were performed by simulation assuming 80% complete data for Lyssn and COACH scores (fidelity strategy) and 95% data available on SMS text messaging (i.e., allowing for up to a very conservative 5% opt-out rate).
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SMS/Text (CAMPI) 		Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
  • Behavioral: SMS/Text (CAMPI)
    Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
  • Behavioral: Family Check-Up 4 Health (FCU4Health)
    An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.
Experimental
Fidelity Monitoring (Lyssn and COACH) 		Standard Training Activities 1. asynchronous training in the program via an e-learning program 2. synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities 3. use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs 4. group supervision (typically for a period of a year provided by a certified Trainer and then taken over by the organization in a train-the-trainer type model) Enhanced Supervision Activities 5. use of the Lyssn system to provide individualized feedback to BHCs All BHCs will receive the standard training activities (a-b). For the experimental condition, half of the BHCs will be randomly assigned to full fidelity support strategy, which will include the standard and enhanced supervision activities (c-e).
  • Behavioral: Fidelity Monitoring (Lyssn and COACH)
    Lyssn's HIPAA-compliant, cloud-based platform uses embedded speech-to-text transcription from audio recorded sessions for rapid assessment and easy session review for supervisors and interventionists. The COACH fidelity rating system assesses clinical skills in five domains considered essential for the effective provision of the FCU and the EDP intervention sessions. The COACH rating form is used to assess the extent to which the provider is: Conceptually accurate and adherent to the intervention model Observant and responsive to the family's needs Active in structuring the session Careful when teaching and providing feedback Helpful in building hope and motivation
  • Behavioral: Family Check-Up 4 Health (FCU4Health)
    An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.
Experimental
SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) 		Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives fidelity monitoring via COACH and Lyssn.
  • Behavioral: SMS/Text (CAMPI)
    Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
  • Behavioral: Fidelity Monitoring (Lyssn and COACH)
    Lyssn's HIPAA-compliant, cloud-based platform uses embedded speech-to-text transcription from audio recorded sessions for rapid assessment and easy session review for supervisors and interventionists. The COACH fidelity rating system assesses clinical skills in five domains considered essential for the effective provision of the FCU and the EDP intervention sessions. The COACH rating form is used to assess the extent to which the provider is: Conceptually accurate and adherent to the intervention model Observant and responsive to the family's needs Active in structuring the session Careful when teaching and providing feedback Helpful in building hope and motivation
  • Behavioral: Family Check-Up 4 Health (FCU4Health)
    An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.
Experimental
No CAMPI or Fidelity Monitoring 		Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).
  • Behavioral: Family Check-Up 4 Health (FCU4Health)
    An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.

Recruiting Locations

Denova Integrated Healthcare
Phoenix, Arizona 85012

More Details

Status
Recruiting
Sponsor
Arizona State University

Study Contact

Michele M Porter, Ph.D.
4802037550
michele.porter@asu.edu

Detailed Description

The proposed implementation trial is a hybrid effectiveness-implementation type III design, with a primary focus on implementation strategies and outcomes. Eligible families include children aged 2-17 who are patients at Denova Collaborative Health, Valleywise Health, Terros Health, or Canyon Pediatrics. All families (n = 400) will receive FCU4Health services from a Denova Collaborative Health, Valleywise Health, Terros Health, or Canyon Pediatrics staff member trained in the intervention and supervised by FCU4Health experts. Following guidance from our ongoing Community Advisory Board, our previous trials, and RE-AIM, implementation barriers were identified to scale-up and implementation strategies adopted for the trial: enhanced fidelity support using LYSSN and SMS text messaging to promote program engagement. Randomization to these strategies will occur at the individual level. Parent/caregivers and children at least 11 years of age will complete assessments at baseline, 4 months, and 9 months. Primary outcomes are fidelity and engagement (Aim 1a) and child health behaviors (Aim 1b). We will also examine secondary outcomes including family health routines and parenting; conduct economic analyses (Aim 2); and examine the link between trajectories of improvement in health behaviors and improvements in BMI for subgroups related to baseline BMI, child developmental age group, race/ethnicity, language, and gender (Aim 3).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.