Clinical trial NCT04469816: AFRI Childhood Obesity Prevention Challenge Area
Official title: The Family Check-Up for Health: A Family-Centered Health Maintenance Approach to Improve Nutrition and Prevent Obesity in Early Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Keywords: Hybrid design
Implementation
Effectiveness
Parent Training
Cost-Effectiveness
Primary Care
Integrated Behavioral Health
Family-Based Prevention
Family Check-Up 4 Health
Fidelity
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2020-07-14
Enrollment: 217
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Participating caregiver who is at least 18 years of age and understands English and/or Spanish well enough to complete study assessment.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in the Family Health Behavior Scale
timeFrame: The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Changes in the HABITS questionnaire
timeFrame: The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Changes in the Family Health Behavior Scale
timeFrame: The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire
timeFrame: The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Children's Behavior Questionnaire
timeFrame: The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Strengths and Difficulties Questionnaire
timeFrame: The investigators will examine trajectories of prosocial behavior over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Strengths and Difficulties Questionnaire
timeFrame: The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Brief Infant Sleep Questionnaire
timeFrame: The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Media Parenting Scale
timeFrame: The investigators will examine trajectories of child media routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: The Family Health Behavior Scale
timeFrame: The investigators will examine trajectories of child physical activity habits over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)
timeFrame: The investigators will examine trajectories of parenting warmth over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)
timeFrame: The investigators will examine trajectories of family conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Child-parent relationship scale
timeFrame: The investigators will examine trajectories of parent child conflict over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: The investigators will examine trajectories of parent depression over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Trajectories of Parenting Daily Hassles (See Reference Section for citing of title)
timeFrame: The investigators will examine trajectories of parenting stress over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Tool for Substance Use Screening
timeFrame: The investigators will examine trajectories of parent substance use over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Trajectories of Parenting Young Children (See Reference Section for citing of title)
timeFrame: The investigators will examine trajectories of incentive and encouragement over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Trajectories of Parenting Young Children (See Reference Section for citing of title)
timeFrame: The investigators will examine trajectories of proactive parenting over 3 annual assessments (baseline, 1-year, 2-year follow-up).
measure: Trajectories of Parenting Young Children (See Reference Section for citing of title)
timeFrame: The investigators will examine trajectories of parent limit setting over 3 annual assessments (baseline, 1-year, 2-year follow-up).
Other outcomes:
Locations:
city: Avondale
country: United States
facility: Avondale School District
state: Arizona
city: Avondale
country: United States
facility: Bayless Integrated Healthcare
state: Arizona
city: Avondale
country: United States
facility: Care1st Avondale Resource and Housing
state: Arizona
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Cady Berkel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Justin D. Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crnic KA, Greenberg MT. Minor parenting stresses with young children. Child Dev. 1990 Oct;61(5):1628-37. doi: 10.1111/j.1467-8624.1990.tb02889.x.
citation: McEachern AD, Dishion TJ, Weaver CM, Shaw DS, Wilson MN, Gardner F. Parenting Young Children (PARYC): Validation of a Self-Report Parenting Measure. J Child Fam Stud. 2012 Jun;21(3):498-511. doi: 10.1007/s10826-011-9503-y.
citation: Stormshak EA, DeGarmo D, Garbacz SA, McIntyre LL, Caruthers A. Using Motivational Interviewing to Improve Parenting Skills and Prevent Problem Behavior During the Transition to Kindergarten. Prev Sci. 2021 Aug;22(6):747-757. doi: 10.1007/s11121-020-01102-w.
citation: Berkel C, Smith JD, Bruening MM, Jordan N, Fu E, Mauricio AM, Grimm KJ, Winslow E, Ray K, Bourne A, Dishion TJ. The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study). Contemp Clin Trials. 2020 Sep;96:106088. doi: 10.1016/j.cct.2020.106088. Epub 2020 Jul 22.