Background
The Family Check-Up for Health program
Study design
Overview
Implementation strategies and service delivery sites
Clinical effectiveness of the FCU4Health
Methods
Study aims
Aim 1
Aim 2
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2b. Employ behavioral intervention costing methods [57] to evaluate the costs of installing and delivering the FCU4Health and conduct a cost–benefit analysis to evaluate the monetary benefits of program effects.
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2c. Develop a plan to support scale-up and sustainment in collaboration with our CAB.
Aim 3
Aim 4
Study participants, recruitment, and randomization
Family Check-Up 4 Health program
Delivery schedule
FCU4Health family health routine assessment
Feedback sessions
Everyday Parenting sessions
Community programs and support services
Phone-based coaching
Services-as-Usual Plus Information condition
Measures
Outcome variable(s) | Measure(s) and data collection procedures | Data source and reporter (when applicable) |
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Stakeholders: acceptability, feasibility, appropriateness, and sustainability | (1) Select scales of the Annual Survey of Evidence-Based Programs [113] (α > .75) | Survey (ST) |
(2) FCU4Health Stakeholder Survey: 11 open-ended questions, adapted from the Treatment Acceptability Rating Form, related to the relevance of the FCU4Health for obesity management, barriers and facilitators of the delivery of the program, and feasibility of this program from the perspective of stakeholders | ||
(3) Program Sustainability Assessment Tool [114]: 8 domains (e.g., funding stability, organizational capacity) with 5 items each (e.g., “The program has sustained funding”) are rated on a 7-point Likert scale (1 = little or no extent, 7 = a very great extent) (α = .88) | ||
Caregivers: acceptability and appropriateness | (1) FCU4Health Caregiver Acceptability Interview, designed for and used in our pilot feasibility trial [50], consists of 11 open-ended questions pertaining to the relevance of the program components to the family’s efforts to manage weight, the acceptability of the program and its components, and the barriers and facilitators of participation | Interview (CG) |
Survey (CG) | ||
Reach | 1- or 2-month sampling period to more closely approximate the number of families that require a service at any given point [63] | EHR data |
Family service participation | Administrative data and Survey (CO) | |
(2) Community Resources: Engagement and Adequacy (CREA): adapted from an existing care coordination measure to assess the extent to which families engaged in community resources (e.g., emergency care, well-child visits, recreational and nutrition programs, mental healthcare, school services, financial services) and if help was needed to obtain the resource and whether those resources met their needs. Response options are as follows: “I didn’t need help”; “I needed help, but didn’t find it”; “I tried this, but it didn’t work”; “I’m still getting help”; and “I got help, and it worked” | Survey (CG) | |
(3) Dosage of Engagement in Community Resources (DECR) [119]: created for this study to assess the amount of time spent in activities to support health behaviors assessed by asking the number of times among 7 response options (e.g., “once a month,” “2–3 times a week,” “2 times every day”) and then the duration of each instance of teach activity using a drop-down menu of min (e.g., 30) to h (e.g., 1, 3, and 8 h or more) | ||
Fidelity | (1) COACH observational rating system [54]: 5 dimensions of observable in-session coordinator skills: conceptual accuracy; observant and responsive to the families’ contexts and needs; actively structures session to optimize effectiveness; carefully teaches and provides corrective feedback; hope and motivation are generated. Each dimension contains exemplars (prescribed behaviors) and non-exemplars (proscribed behaviors) and is rated on a 9-point scale: 1–3 (needs work); 4–6 (competent work); 7–9 (excellent work) (ICC ≥ .73) [120]. Variability in fidelity ratings to feedback sessions have been associated with long-term changes in parenting skills and child behavioral outcomes [53‐55] | Observational |
(2) Automated coding of fidelity is being developed within this study (aim 2b) | Automated coding | |
Costs and health economics | (1) Cost capture survey [57] | Survey (ST) |
Survey (CO) | ||
(3) Electronic budgets | Administrative data | |
(4) Health plan claims data | Administrative data |
Outcome variable(s) | Measure(s) and data collection procedures | Data source and reporter (when applicable) |
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Child weight and body composition | Portable electronic scale (Tanita SC-331SU) approved by the FDA for BMI and body composition in children (ages 5 to 18) and adults. Child BMI is standardized by sex and age according to the CDC growth reference data for children [121] | Anthropometric |
Child dietary habits | NHANES Dietary Screener Questionnaire [122]: 9-point scale (0 = never, 8 = 6 or more times per day) to rate 3 items about fruit, vegetable, and fast-food choices (e.g., “In the past month, how often did you eat fruit?”) and 3 items regarding sugar-sweetened beverage choices (e.g., “In the past month, how often did you drink regular soda that contained sugar?”) | Survey (CG) |
Family health routines and health behaviors | (1) Family Health Behaviors Scale [123]: 24 items rated on a 5-point scale (0 = almost never, 4 = nearly always; e.g., “I participate in physical activity with [child name]; [child name] sneaks food”). Caregiver ratings on this scale are sensitive to change and have been shown to predict child weight classification | Survey (CG, CH) |
(2) Sleep parenting routines: 6 items on a 5-point scale (0 = almost never, 4 = nearly always; e.g., [child name] goes to bed at about the same time each night). Items developed from existing measures, such as the Brief Infant Sleep Questionnaire [124] | ||
(3) Media parenting routines: 6 items on a 5-point scale (0 = almost never, 4 = nearly always; e.g., “I keep track of [child name]’s screen-time”) and a single question on h per day of media use. Items were drawn from published studies and measures [125] | ||
Parenting and family management skills | Questionnaires encompass 3 domains of parenting and family management skills: (1) positive behavior support, (2) relationship quality, and (3) monitoring and limit setting. Each of these measures has been used in previous FCU trials and was found to have adequate reliability, internal consistency, and sensitivity to change | Survey (CG, CH) |
Caregiver: 5-point scale (0 = never, 4 = very often) on the domains of incentives and encouragement (4 items; e.g., “Gave [child name] a hug, kiss, or kind word”) [126]; proactive parenting (7 items; e.g., “Plan for ways to prevent problem behavior”) [127], parent–child conflict (10 items; e.g., “[child name] gets angry at me easily”); family conflict (5 items; e.g., “We got angry at each other”) [126]; quality time (6 items; e.g., “Involve [child name] in household chores”) [127], parent warmth (5 items; e.g., “If upset, [child name] seeks comfort from me”) [128]; family routines (7 items; e.g., “Check to see if [child name] has homework”); limit setting (7 items, e.g., “Speak calmly with [child name] when you were upset with him/her”), negative parent behavior (5 items; e.g., “Criticize [child name]”) [127]; and a single question on h per day of unsupervised time | ||
Child: 4 items on incentives and encouragement (e.g., “Praised you or complimented you for something you did well”), using a 5-point scale (0 = never, 4 = very often); 4-item questionnaire on family conflict (e.g., “I got my way by getting angry”), using a 7-point scale (0 = never, 6 = 8+ times) [126] | ||
Family interaction task (FIT) observational coding system [129]: the recorded family interactions are scored for caregiver(s) behaviors in the domains of relationship quality, positive behavior support, and monitoring and limit setting, as well as demonstrated knowledge of children’s health behaviors (e.g., age-appropriate physical activity duration and dietary guidelines). Child behaviors and emotional adaptation are rated. Each domain is rated for parent’s skill/knowledge on a 5-point scale (1 = low, 5 = high) for each interaction task independently | Observational | |
Child self-regulation | Caregiver: 13-item survey (e.g., “[child name] is able to resist laughing or smiling when it isn’t appropriate”) adapted from the Children’s Behavior Questionnaire [130], using a 5-point scale (1 = almost always untrue, 5 = almost always true) | Survey (CG, CH) |
Child: 16-item questionnaire (e.g., “I pay close attention when someone tells me how to do something”) adapted from the Early Adolescent Temperament Questionnaire [131], using a 6-point scale (1 = always untrue, 5 = always true) | ||
Weight-related stigma | Perception of Teasing Scale [132]: children will use a 5-point scale (1 = never/not upset, 4 = very often/extremely upset) to rate the frequency of 3 events pertaining to weight-related stigma and describe their level of distress associated with these items (e.g., “People made fun of you because you were heavy”; “How upset does this make you?”) | Survey (CH) |
Body image | Body Image Scale for Children: a pictorial scale using body pictures representing standardized percentile curves of BMI for boys and girls, separately; good reliability and evidence of validity with children aged 7 to 12 [133]; proxy for satisfaction and a measure of potential adverse effects of participation in the program/study | Survey (CH) |
Quality of life | Pediatric Quality of Life Inventory [134]: 23 items in four categories: physical functioning, emotional functioning, social functioning, and school functioning | Survey (CG, CH) |
Caregivers: 5-point scale (0 = never, 4 = almost always) to rate items (e.g., “[child name] feels afraid or scared”; “[child name] gets along with other children”) | ||
Children: 3-point scale (0 = not at all, 2 = somewhat, 4 = a lot) to rate items (e.g., “It is hard for me to run”; “It is hard for me to pay attention in school”) adjusted for 2 age groups: 5–7 years old and 8–12 years old | ||
Satisfaction with care | (1) Family Check-Up Caregiver Service Satisfaction Survey: 9 items rated on a 4-point scale (0 = strongly disagree, 4 = strongly agree) adapted from the Client Satisfaction Questionnaire [135] to be specific to parent training programs. This was developed for use with the original FCU conducted in community mental health clinics [89] (α = .95) in that trial | Survey (CG) |
(2) Parent Experience of Assessment Survey (PEAS) [136]: 3 of the 5 subscales (parent–coordinator collaboration, systemic awareness, and negative feelings) with 15 total items rated on a 5-point scale (1 = strongly disagree, 5 = strongly agree) (α > .75) | ||
Child adjustment | Strengths and Difficulties Questionnaire [137]: caregivers and children rate 5 items each on a 3-point scale (0 = not true, 1 = somewhat true, 4 = very true) on the conduct problems (e.g., “I/[child name] often lose(s) temper”), hyperactivity (e.g., “I am/[child name] is constantly fidgeting or squirming”), pro-social behavior (e.g., “I am/[child name] is considerate of other people’s feelings”), and emotional problems (e.g., “I am/[child name] is often unhappy, depressed, or sad”) subscales | Survey (CG, CH) |