An interventional study of SMS/Text (CAMPI) and Fidelity Monitoring (Lyssn and COACH) in Clinical Trial, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Arizona State University · Not applicable, Interventional, and Prevention
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.
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).
967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.
This study's planned enrollment of 400 is above the median of 150 across 824 interventional studies indexed under Health Behavior.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Behavioral: Family Check-Up 4 Health (FCU4Health)
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) · Behavioral: Family Check-Up 4 Health (FCU4Health)
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) · Behavioral: Fidelity Monitoring (Lyssn and COACH) · Behavioral: Family Check-Up 4 Health (FCU4Health)
Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).
Behavioral: Family Check-Up 4 Health (FCU4Health)
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
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
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.
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
Child Health Behaviors: Dietary Screener Questionnaire
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.
Time frame: Baseline, 4, and 9 months
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
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.
Time frame: Baseline and 9 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.
Time frame: 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.
Time frame: Month 9
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.
Time frame: Month 9
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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 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.
Time frame: Baseline, 4, and 9 months
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
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