Clinical Trial
Conditions
Keywords
implementation, cost-effectiveness, health behaviors, BMI
Brief 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.
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).
Interventions
BEHAVIORALSMS/Text (CAMPI)
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
BEHAVIORALFidelity 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
BEHAVIORALFamily 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.
Sponsors
Arizona State University
Northwestern University
University of Oregon
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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).
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI at or above 85 percentile for age and gender.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lyssn Fidelity Ratings | Up to 36 months | 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). |
| Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement) | Up to 36 months | 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. |
| Budget impact of implementation | Up to 48 months | Co-Primary outcome of Aim 2: Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided. |
| Cost-effectiveness of FCU4Health | Up to 48 months | 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. |
| Child Health Behaviors: Dietary Screener Questionnaire | Baseline, 4, and 9 months | Primary outcome of Aim 1b and Aim 3: National Health and Nutrition Examination Survey's Dietary Screener Questionnaire: 6 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? Frequency of choices within past 2 weeks). 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. Values range from 0-8. Never=0, 5-6 times per week=4, 6+per day=8. For food items, higher scores indicate healthier behaviors. For the beverage choices, lower scores indicate healthier behaviors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COACH Fidelity Rating System | Up to 36 months | 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. |
| Engagement (participation) in FCU4Health services | From enrollment to end of intervention at 9 months | FCU4Health services received (attendance at intervention sessions, referrals completed) |
| Engagement in home practice | From enrollment to end of intervention at 9 month | 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). |
| Engagement with the SMS text messaging platform | From enrollment to end of intervention at 9 month | 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. |
| Child BMI - Percentage of the 95th percentile (BMIp95) | Baseline and 9 months | 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. |
| Reach of the intervention | Up to 36 months | 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. |
| Normalisation MeAsure Development questionnaire | Month 9 | 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. |
| Maintenance/Sustainability | Month 9 | 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. |
| Parenting Skills: Incentives and Encouragement | Baseline, 4, and 9 months | 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. |
| Parenting Skills: Proactive Parenting | Baseline, 4, and 9 months | 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. |
| Parenting Skills: Parenting Warmth | Baseline, 4, and 9 months | 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. |
| Parenting Skills: Parent-Child Conflict | Baseline, 4, and 9 months | 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. |
| Parenting Skills: Quality Time | Baseline, 4, and 9 months | 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. |
| Parenting Skills: Monitoring and Limit Setting | Baseline, 4, and 9 months | 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. |
| Parenting Skills: Negative Parenting Behaviors | Baseline, 4, and 9 months | 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. |
| Family Health Routines: Mealtime | Baseline, 4, and 9 months | 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. |
| Family Health Routines: Media | Baseline, 4, and 9 months | 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. |
| Family Health Routines: Sleep | Baseline, 4, and 9 months | 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. |
Countries
United States
Contacts
CONTACTMichele M Porter, Ph.D.
CONTACTCady Berkel, Ph.D.
PRINCIPAL_INVESTIGATORCady Berkel, Ph.D.
Arizona State University
PRINCIPAL_INVESTIGATORJustin D Smith, Ph.D.
University of Utah
Outcome results
None listed