AFRI Childhood Obesity Prevention Challenge Area
- Conditions
- Clinical Trial
- Interventions
- Behavioral: Family Check-Up 4 HealthOther: Services as Usual
- Registration Number
- NCT04469816
- Lead Sponsor
- Arizona State University
- Brief Summary
This study is a hybrid type 2 effectiveness-implementation trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their age (2-5 years old) and randomized to receive the intervention, FCU4Health, or services as usual. All families will be assessed annually over three years.
- Detailed Description
The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents complete a comprehensive assessment, including questionnaire of the family environment, parenting skills, and child adjustment and health behaviors, and additional observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to engage families in making change to support child behavioral health, and to create tailored follow-up services which include parent training modules and referrals to additional support services in the community.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Participating caregiver who is at least 18 years of age and understands English and/or Spanish well enough to complete study assessment.
- Two exceptions: (1) Children with special needs that preclude engagement in a nutrition-based behavioral intervention (e.g., g-tube dependence) and (2) children who are in state custody.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Behavioral: Family Check-Up 4 Health Family Check-Up 4 Health Families will receive the FCU4Health program 3 times annually in a health maintenance model. The FCU4Health coordinator reviews the assessment results with the parents, using motivational interviewing strategies to create a tailored plan to address family needs. This plan may include referrals to community resources or parenting modules that focus on family management. Control-Services as Usual Services as Usual Families will continue with their medical standard of care and referrals for services as appropriate from the healthcare staff in their respective FQHCs or primary healthcare clinics. Families will receive brochures about the community programs to which families in the FCU4Health arm are referred.
- Primary Outcome Measures
Name Time Method Changes in the Family Health Behavior Scale The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up). Child Eating Behaviors. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a worse outcome.
Changes in the HABITS questionnaire The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up). Child Food and Beverage Choices. Food Minimum Value: 0. Maximum Value: 24. Where higher food scores mean a better outcome and higher beverage scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method Brief Infant Sleep Questionnaire The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up). Sleep Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Children's Behavior Questionnaire The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up). Effortful Control. Minimum Value: 1. Maximum Value: 5. Where higher scores mean a better outcome.
Center for Epidemiologic Studies Depression Scale The investigators will examine trajectories of parent depression over 3 annual assessments (baseline, 1-year, 2-year follow-up). Depression. Minimum Value: 0. Maximum Value: 80. Where higher scores mean a worse outcome.
Trajectories of Parenting Young Children (See Reference Section for citing of title) The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up). Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.
Tool for Substance Use Screening The investigators will examine trajectories of parent substance use over 3 annual assessments (baseline, 1-year, 2-year follow-up). Parent Substance Use. Minimum Value: 0. Maximum Value: 1. Where higher scores mean a worse outcome.
Strengths and Difficulties Questionnaire The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up). Emotional Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.
The Family Health Behavior Scale The investigators will examine trajectories of child physical activity habits over 3 annual assessments (baseline, 1-year, 2-year follow-up). Child Physical Activity Habits. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Child-parent relationship scale The investigators will examine trajectories of parent child conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up). Parent Child Conflict. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.
Media Parenting Scale The investigators will examine trajectories of child media routines over 3 annual assessments (baseline, 1-year, 2-year follow-up). Media Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.
Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title) The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up). Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.
Trajectories of Parenting Daily Hassles (See Reference Section for citing of title) The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up). Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.
Trial Locations
- Locations (4)
Bayless Integrated Healthcare
🇺🇸Avondale, Arizona, United States
Avondale School District
🇺🇸Avondale, Arizona, United States
Care1st Avondale Resource and Housing
🇺🇸Avondale, Arizona, United States
Arizona State University
🇺🇸Tempe, Arizona, United States