Primary Care Evidence-based Approach for Improving Lifelong Health

ConditionClinical Trial

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2+

SponsorArizona State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI at or above 85 percentile for age and gender.

Disqualifiers

N/A

Trial design

Design model

Factorial

Treatments tested in this trial

SMS/Text (CAMPI)
Behavioral
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
Fidelity Monitoring (Lyssn and COACH)
Behavioral
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
Family Check-Up 4 Health (FCU4Health)
Behavioral
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.

Treatment groups

400 Participants

are divided into 4 treatment groups

Group A: SMS/Text (CAMPI)Experimental treatment 2 interventions

Group B: Fidelity Monitoring (Lyssn and COACH)Experimental treatment 2 interventions

Group C: SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)Experimental treatment 3 interventions

Group D: No CAMPI or Fidelity MonitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Lyssn Fidelity Ratings

Co-primary outcome of Aim 1: Fidelity to the motivational interviewing (MI) skills that are central to Family Check-Up 4 Health effects using the Lyssn automated coding platform. The system has been shown to be competitive with human coding using the Motivational Interviewing Skill Code (MISC) and the Motivational Interviewing Treatment Integrity Code (MITI 4). The Lyssn fidelity rating system consists of three dimensions: acceptance, empathy, and spirit, scored on a 7-point Likert scale. (1=low rating, 4=mid rating, 7=high rating). Lyssn scores are also convergent with human codings on the COACH observational rating system (see next measure).

Time frame

Up to 36 months

Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement)

Co-primary outcome of Aim 1: COACH rating system Parent In-Session Engagement Domain, 1-9 scale (1=low, 5=moderate, 9=high). Reliable and validly predictive of intervention outcomes.

Time frame

Up to 36 months

Budget impact of implementation

Co-Primary outcome of Aim 2: Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided.

Time frame

Up to 48 months

Cost-effectiveness of FCU4Health

Co-Primary outcome of Aim 2: Cost-effectiveness analysis using incremental cost-effectiveness ratios will be used to determine the value of each strategy as it relates to child BMI change and to implementation outcomes known to be related to intervention effects (e.g., fidelity). Data obtained via Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided.

Time frame

Up to 48 months

Secondary outcomes

COACH Fidelity Rating System

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 (COACH) observational rating system for FCU4Health consists of 5 domains, 1-9 scale (1=needs work, 5=competent work, 9=excellent work). Ratings have been found to be reliable and validly predict engagement and effectiveness outcomes.

Time frame

Up to 36 months

Engagement (participation) in FCU4Health services

FCU4Health services received (attendance at intervention sessions, referrals completed)

Time frame

From enrollment to end of intervention at 9 months

Engagement in home practice

FCU4Health coordinator ratings of home practice using a rating scale found to be predictive of program outcomes, 1-9 scale. High Engagement (scores 7-9) Moderate Engagement (scores 4-6) Low Engagement (scores 1-3).

Time frame

From enrollment to end of intervention at 9 month

Engagement with the SMS text messaging platform

SMS Text messaging interactions (parent read/ response percentage rates)in the Configurable Assessment Messaging Platform for Interventions (CAMPI) platform \*only for those in SMS study condition.

Time frame

From enrollment to end of intervention at 9 month

Other outcomes

Satisfaction with FCU4Health Parent Service

FCU4Health Parent Service Satisfaction Survey. 8 items (α\>.95). Adapted from the validated Client Satisfaction Questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Time frame

4 and 9 months

Satisfaction with FCU4Health Parent-Coordinator

Parent-Coordinator Collaboration, Systemic Awareness, and Negative Feelings subscales of the Parent Experience of Assessment Survey (12 items total; α\>.75) The survey uses a 5-point Likert scale (1=Strongly Disagree, 3=Neutral, 5=Strongly Agree) with the higher number indicating greater satisfaction.

Time frame

4 and 9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

Northwestern University

Collaborator

University of Oregon

Collaborator

University of Utah

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

Apply now