Clinical Trial
Conditions
Keywords
Hybrid design, Implementation, Effectiveness, Parent Training, Cost-Effectiveness, Primary Care, Integrated Behavioral Health, Family-Based Prevention, Family Check-Up 4 Health, Fidelity
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.
Interventions
OTHERServices as Usual
Services/Treatment as usual.
BEHAVIORALFamily Check-Up 4 Health
A parent-training intervention to improve child health, school readiness and manage obesity.
Sponsors
Northwestern University
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Family Health Behavior Scale | The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up). | Family Mealtime Routines. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a better 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title) | The investigators will examine trajectories of parenting warmth over 3 annual assessments (baseline, 1-year, 2-year follow-up). | Parenting Warmth. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome. |
| Strengths and Difficulties Questionnaire | The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up). | Conduct Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse 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 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. |
| 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. |
| Trajectories of Parenting Young Children (See Reference Section for citing of title) | The investigators will examine trajectories of incentive and encouragement over 3 annual assessments (baseline, 1-year, 2-year follow-up). | Incentive and Encouragement. Minimum Value: 0. Maximum Value: 4. 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. |
| 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. |
Countries
United States
Outcome results
None listed