NCT04469816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6.7 years

First QC Date

June 26, 2020

Last Update Submit

May 21, 2025

Conditions

Clinical Trial

Keywords

Hybrid designImplementationEffectivenessParent TrainingCost-EffectivenessPrimary CareIntegrated Behavioral HealthFamily-Based PreventionFamily Check-Up 4 HealthFidelity

Outcome Measures

Primary Outcomes (3)

  • Changes in the Family Health Behavior Scale

    Family Mealtime Routines. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a better outcome.

    The investigators will examine trajectories of family mealtime routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • Changes in the HABITS questionnaire

    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.

    The investigators will examine trajectories of child food and beverage choices over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • Changes in the Family Health Behavior Scale

    Child Eating Behaviors. Minimum Value: 0. Maximum Value: 20. Where higher scores mean a worse outcome.

    The investigators will examine trajectories of child eating behaviors over 3 annual assessments (baseline, 1-year, 2-year follow-up).

Secondary Outcomes (16)

  • Strengths and Difficulties Questionnaire

    The investigators will examine trajectories of child conduct problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • Children's Behavior Questionnaire

    The investigators will examine trajectories of child effortful control over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • Strengths and Difficulties Questionnaire

    The investigators will examine trajectories of prosocial behavior over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • Strengths and Difficulties Questionnaire

    The investigators will examine trajectories of emotional problems over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • Brief Infant Sleep Questionnaire

    The investigators will examine trajectories of child sleep routines over 3 annual assessments (baseline, 1-year, 2-year follow-up).

  • +11 more secondary outcomes

Study Arms (2)

Behavioral: Family Check-Up 4 Health

EXPERIMENTAL

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.

Behavioral: Family Check-Up 4 Health

Control-Services as Usual

EXPERIMENTAL

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.

Other: Services as Usual

Interventions

Family Check-Up 4 HealthBEHAVIORAL

A parent-training intervention to improve child health, school readiness and manage obesity.

Also known as: FCU4Health
Behavioral: Family Check-Up 4 Health
Services as UsualOTHER

Services/Treatment as usual.

Control-Services as Usual

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Avondale School District

Avondale, Arizona, 852323, United States

Location

Bayless Integrated Healthcare

Avondale, Arizona, 85323, United States

Location

Care1st Avondale Resource and Housing

Avondale, Arizona, 85323, United States

Location

Arizona State University

Tempe, Arizona, 85281, United States

Location

Related Publications (4)

  • 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.

    PMID: 2245752BACKGROUND

  • 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.

    PMID: 22876108BACKGROUND

  • 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.

    PMID: 32036553BACKGROUND

  • 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.

    PMID: 32707101DERIVED

Study Officials

  • Cady Berkel, Ph.D.

    Arizona State University

    PRINCIPAL INVESTIGATOR

  • Justin D. Smith, Ph.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 14, 2020

Study Start

May 17, 2017

Primary Completion

January 29, 2024

Study Completion

January 31, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)