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AFRI Childhood Obesity Prevention Challenge Area

Primary Purpose

Clinical Trial

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family Check-Up 4 Health

Services as Usual

About this trial

This is an interventional prevention trial for Clinical Trial focused on measuring Hybrid design, Implementation, Effectiveness, Parent Training, Cost-Effectiveness, Primary Care, Integrated Behavioral Health, Family-Based Prevention, Family Check-Up 4 Health, Fidelity

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Avondale School District
Bayless Integrated Healthcare
Care1st Avondale Resource and Housing
Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Behavioral: Family Check-Up 4 Health

Control-Services as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in the Family Health Behavior Scale

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

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.

Changes in the Family Health Behavior Scale

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

Secondary Outcome Measures

Strengths and Difficulties Questionnaire

Conduct Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.

Children's Behavior Questionnaire

Effortful Control. Minimum Value: 1. Maximum Value: 5. Where higher scores mean a better outcome.

Strengths and Difficulties Questionnaire

Prosocial Behavior. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a better outcome.

Strengths and Difficulties Questionnaire

Emotional Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.

Brief Infant Sleep Questionnaire

Sleep Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

Media Parenting Scale

Media Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

The Family Health Behavior Scale

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)

Parenting Warmth. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.

Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)

Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.

Child-parent relationship scale

Parent Child Conflict. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.

Center for Epidemiologic Studies Depression Scale

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)

Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.

Tool for Substance Use Screening

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)

Incentive and Encouragement. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

Trajectories of Parenting Young Children (See Reference Section for citing of title)

Proactive Parenting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

Trajectories of Parenting Young Children (See Reference Section for citing of title)

Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

Full Information

NCT ID

NCT04469816

First Posted

June 26, 2020

Last Updated

August 2, 2021

Sponsor

Arizona State University

Collaborators

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04469816

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 17, 2017 (Actual)

Primary Completion Date

March 30, 2022 (Anticipated)

Study Completion Date

April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arizona State University

Collaborators

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Behavioral: Family Check-Up 4 Health

Arm Type

Experimental

Arm Description

Arm Title

Control-Services as Usual

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Family Check-Up 4 Health

Other Intervention Name(s)

FCU4Health

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Services as Usual

Intervention Description

Services/Treatment as usual.

Primary Outcome Measure Information:

Title

Changes in the Family Health Behavior Scale

Description

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

Time Frame

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

Title

Changes in the HABITS questionnaire

Description

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.

Time Frame

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

Title

Changes in the Family Health Behavior Scale

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Strengths and Difficulties Questionnaire

Description

Conduct Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.

Time Frame

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

Title

Children's Behavior Questionnaire

Description

Effortful Control. Minimum Value: 1. Maximum Value: 5. Where higher scores mean a better outcome.

Time Frame

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

Title

Strengths and Difficulties Questionnaire

Description

Prosocial Behavior. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a better outcome.

Time Frame

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

Title

Strengths and Difficulties Questionnaire

Description

Emotional Problems. Minimum Value: 0. Maximum Value: 2. Where higher scores mean a worse outcome.

Time Frame

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

Title

Brief Infant Sleep Questionnaire

Description

Sleep Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

Time Frame

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

Title

Media Parenting Scale

Description

Media Routines. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

Time Frame

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

Title

The Family Health Behavior Scale

Description

Child Physical Activity Habits. Minimum Value: 0. Maximum Value: 24. Where higher scores mean a better outcome.

Time Frame

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

Title

Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)

Description

Parenting Warmth. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.

Time Frame

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

Title

Trajectories of Community Action for Successful Youth Measure (See Reference Section for citing of title)

Description

Family Conflict. Minimum Value: 0. Maximum Value: 6. Where higher scores mean a worse outcome.

Time Frame

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

Title

Child-parent relationship scale

Description

Parent Child Conflict. Minimum Value: 1. Maximum Value: 25. Where higher scores mean a worse outcome.

Time Frame

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

Title

Center for Epidemiologic Studies Depression Scale

Description

Depression. Minimum Value: 0. Maximum Value: 80. Where higher scores mean a worse outcome.

Time Frame

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

Title

Trajectories of Parenting Daily Hassles (See Reference Section for citing of title)

Description

Parenting Stress. Minimum Value: 1. Maximum Value: 4. Where higher scores mean a worse outcome.

Time Frame

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

Title

Tool for Substance Use Screening

Description

Parent Substance Use. Minimum Value: 0. Maximum Value: 1. Where higher scores mean a worse outcome.

Time Frame

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

Title

Trajectories of Parenting Young Children (See Reference Section for citing of title)

Description

Incentive and Encouragement. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

Time Frame

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

Title

Trajectories of Parenting Young Children (See Reference Section for citing of title)

Description

Proactive Parenting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

Time Frame

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

Title

Trajectories of Parenting Young Children (See Reference Section for citing of title)

Description

Limit Setting. Minimum Value: 0. Maximum Value: 4. Where higher scores mean a better outcome.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cady Berkel, Ph.D.

Organizational Affiliation

Arizona State University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Justin D. Smith, Ph.D.

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Avondale School District

City

Avondale

State/Province

Arizona

ZIP/Postal Code

852323

Country

United States

Facility Name

Bayless Integrated Healthcare

City

Avondale

State/Province

Arizona

ZIP/Postal Code

85323

Country

United States

Facility Name

Care1st Avondale Resource and Housing

City

Avondale

State/Province

Arizona

ZIP/Postal Code

85323

Country

United States

Facility Name

Arizona State University

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85281

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

2245752

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.

Results Reference

background

PubMed Identifier

22876108

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.

Results Reference

background

PubMed Identifier

32036553

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.

Results Reference

background

PubMed Identifier

32707101

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.

Results Reference

derived

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AFRI Childhood Obesity Prevention Challenge Area

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