Primary Care Evidence-based Approach for Improving Lifelong Health
NCT Number: NCT06526312
Acronym: PREVAIL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Clinical Trial
Interventions: BEHAVIORAL: SMS/Text (CAMPI)|BEHAVIORAL: Fidelity Monitoring System (Lyssn)|BEHAVIORAL: Family Check-Up 4 Health (FCU4Health)
Sponsor: Arizona State University
Collaborators: Northwestern University|University of Oregon|University of Utah|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2028-07
Locations: Denova Integrated Healthcare, Phoenix, Arizona, 85012, United States

Summary:
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.

Primary Outcome Measures: 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)., 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., 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., 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., Up to 48 months|Child Health Behaviors: Dietary Screener Questionnaire, Primary outcome of Aim 1b and Aim 3:

National Health and Nutrition Examination Survey's Dietary Screener Questionnaire: 15 questions collect intake frequency of food (fruits, vegetables, fast food) and beverage choices (regular soda, 100 percent fruit juice, or sweetened fruit drinks, sports drinks, or energy drinks) during the past month. (i.e. During the past month, how often did you drink regular soda that contains sugar? Quantity in days/weeks/months) The Dietary Screener Questionnaire has been shown to be a low burden food recall screener for specific dietary factors.

This scale was administered in investigator's Centers for Disease Control and Prevention (CDC) funded trial and had good psychometrics as demonstrated using confirmatory factor analysis., Baseline, 6, 12, and 18 months
Secondary Outcome Measures: 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., Up to 36 months|Engagement (participation) in FCU4Health services, FCU4Health services received (attendance at intervention sessions, referrals completed), From enrollment to end of intervention at 18 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)., From enrollment to end of intervention at 18 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., From enrollment to end of intervention at 18 month|Child BMI - Percentage of the 95th percentile (BMIp95), Secondary outcome of Aim 1b and Aim 3: Children will be weighed using a portable electronic dual frequency bioelectrical impedance scale (Tanita SC-331SU). A portable stadiometer will take two height measurements, which are then averaged.

A third measurement is taken if the ﬁrst two differ by more than one-eighth of an inch. Child BMI will be standardized by age and gender according to the CDC growth reference data for children, and percentage of the 95th percentile (BMIp95) will be calculated, as this is a more robust metric for assessing pediatric BMI change over time., Baseline and 18 months|Reach of the intervention, Secondary outcome of Aim 1: 1. Proportion of enrolled children/families (study participants) referred to FCU4Health / number eligible.

2. Proportion of referred children/families engaged in the intervention / number eligible., Up to 36 months|Normalisation MeAsure Development questionnaire, Secondary outcome of Aim 1: Acceptability, appropriateness, and feasibility of the implementation strategies.

The Normalisation MeAsure Development questionnaire (NoMAD) comprises 23-items, concerned with: implementation (bringing a practice or practices into action); embedding (when a practice or practices may be routinely incorporated in everyday work); and integration (when a practice or practices are reproduced and sustained in the social matrices of an organization). A 5-point Likert scale is used for all responses (1=disagree, 3=neither agree nor disagree, 5=agree). Particularly relevant for evaluating implementation of technology in primary care., Month 6, Month 16, Month 24|Maintenance/Sustainability, Secondary outcome of Aim 1: Clinical Sustainability Assessment Tool: 21 items, 7 domains: Engaged Leadership and Staff; Engaged Stakeholders; Planning and Implementation; Workflow Integration; Monitoring and Evaluation; Organizational Context and Capacity; Outcomes and Effectiveness. A 7-point Likert scale is used for all domains (1=little or no extent, 4=some extent, 7=great extent). Reliable and valid., Month 6, Month 16, Month 24|Parenting Skills: Incentives and Encouragement, Secondary outcome of Aim 1b:

The Positive Behavior Support: Incentives and Encouragement survey consists of 4 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better positive behavior supports in the domain of parent incentives and encouragement.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Parenting Skills: Proactive Parenting, Secondary outcome of Aim 1b:

The Positive Behavior Support: Proactive Parenting survey consists of 7 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better positive behavior supports in the domain of proactive parenting.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Parenting Skills: Parenting Warmth, Secondary outcome of Aim 1b:

The Relationship Quality: Parenting Warmth survey consists of 5 items and uses a 5-point Likert scale (1=not at all, 3=somewhat true, 4=very true). Higher scores indicating better ratings of relationship quality in the domain of parenting warmth.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Parenting Skills: Parent-Child Conflict, Secondary outcome of Aim 1b:

The Relationship Quality: Parent-Child Conflict survey consists of 10 items and uses a 5-point Likert scale (1=not at all, 3=somewhat true 4=very true). Lower scores indicating better ratings of relationship quality in the domain of parent-child conflict.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Parenting Skills: Quality Time, Secondary outcome of Aim 1b:

The Relationship Quality: Quality Time survey consists of 6 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better ratings of relationship quality in the domain of parent-child quality time.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Parenting Skills: Monitoring and Limit Setting, Secondary outcome of Aim 1b:

The Monitoring and Limit Setting survey consists of 7 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better parent monitoring and limit setting.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Parenting Skills: Negative Parenting Behaviors, Secondary outcome of Aim 1b:

The Negative Parent Behaviors survey consists of 5 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Lower scores indicating better ratings of parent behaviors.

This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable., Baseline, 6, 12, and 18 months|Family Health Routines: Mealtime, Secondary outcome of Aim 1b: Mealtime Parenting Scale: 5 items using a 5-point Likert scale (0=almost never, 2=sometimes, 4=nearly always). Scale was administered in investigator's CDC-funded trial and had good psychometrics as demonstrated using confirmatory factor analysis., Baseline, 6, 12, and 18 months|Family Health Routines: Media, Secondary outcome of Aim 1b: Media Parenting Scale: 3 items using a 5-point Likert scale (0=almost never, 2=sometimes, 4=nearly always). Scale was administered in investigator's CDC-funded trial and had good psychometrics as demonstrated using confirmatory factor analysis., Baseline, 6, 12, and 18 months|Family Health Routines: Sleep, Secondary outcome of Aim 1b: Sleep Parenting Scale 8 items from existing scales that have shown high validity and reliability (i.e., Children's Sleep Wake Scale, Children's Sleep Hygiene Scale, Parental Interactive Behaviour Scale, Brief Infant Sleep Questionnaire and the Sleep Environment Scale). Uses a 5-point Likert scale (0=almost never, 2=sometimes, 4=nearly always). Scale was administered in investigator's CDC-funded trial and had good psychometrics as demonstrated using confirmatory factor analysis., Baseline, 6, 12, and 18 months
Other Outcome Measures: 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., Month 12 and Month 18 surveys to parents|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., Month 12 and Month 18 surveys to parents