Family Check-Up Online (FCO)

Family Check-Up Online for Middle School Parents

The goal of this clinical trial is to test the benefits of the Family Check-Up Online Program for parents of middle school students in Arizona. Participants will complete an online pre-survey, gain access to the online parenting program Family Check-Up, and have the option to meet with a coach to discuss the program. The participants will also complete a post-survey 3 months after enrollment.

Study Overview

• Status: Active, not recruiting
• Conditions: Families of Middle School Students at Title 1 Schools
• Intervention / Treatment: Behavioral: Family Check-Up Online

Detailed Description

The lingering impact of the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, and social/familial functioning. Given the scale of the pandemic's impact on families with school-aged children, the implementation of effective family-focused programs that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represents critical public health goals.

Toward this end, this project is designed to further examine the efficacy of a web-based version of the universal Family Check-Up prevention program, which is an empirically-supported, parent-focused program designed to promote resilience and improve family functioning among parents of middle school-aged youth (grades 6-8th). A randomized control trial conducted through the University of Oregon found that parents who completed the Family Check-up Online program (FCO) either with or without supplemental support coaching exhibited significant increases in confidence and effortful control related to implementing skills and strategies that promote positive emotional and behavioral health among teens. This suggests that parents who complete the program feel more empowered to help guide their child's positive decision making and more effectively manage family challenges.

This project will examine whether the FCO program produces improvements in positive parenting practices, reductions in parental emotional distress, and reductions in youth emotional/behavioral problems when delivered as a universal prevention program targeting parents of 6-8th grade students attending Title 1 public schools (>50% students eligible for free/reduced lunch). The investigators will also examine whether the structured parent coaching support component of the program (i.e., Guidance Coaching) helps to improve the program's effectiveness relative to a parent-initiated informational support condition.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All parents with a child enrolled in grades 6-8 at participating Title 1 public schools will be invited to take part in the study.

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informational Support; Parents will be told that they have the option of contacting an informational support specialist any point while completing the program to address questions and discuss the program. Parents will be informed that their questions can be addressed via e-mail or alternatively they can schedule a time to talk with their coach via phone or Zoom. The informational support specialist will not initiate contact with parents in this condition.	Behavioral: Family Check-Up Online; Families will be provided with access to the FCO program, available in English or Spanish. Parents complete a tutorial and five different modules focused on distinct parenting skills. Each module starts with a survey and feedback to help identify relative strengths and challenges with the targeted parenting skills. Parents are then guided through various online activities including videos that model right and wrong ways to handle comm on situations and explanations of parental self-management and problem-solving strategies. Parents are complete activities to practice the parenting skills taught. Parents will have access to the online program for 8 and they are encouraged to practice the program strategies during this time period. At the end of the 8 weeks, parent re-complete the brief questions that they filled out at the beginning of each module and then receive feedback indicating which of the parent's domain scores have improved since they completed each module.
Experimental: Guidance Coaching; Parents will be informed that they have been assigned a guidance coach who will contact them via email to schedule 1-3 check-in meetings over the phone or via Zoom while they complete the online program. These meetings are structured to help establish parental goals for the program, offer emotional support, and help motivate parents to implement new parenting skills. During these contacts, coaches use motivational interviewing techniques to help promote and support behavioral change. These coaching contacts are designed to be brief and focused, and typically last for less than 30 minutes. Coach contacts are scheduled based on the parents' availability and interest, and additional coaching sessions can be requested by the parent at any point during the program.	Behavioral: Family Check-Up Online; Families will be provided with access to the FCO program, available in English or Spanish. Parents complete a tutorial and five different modules focused on distinct parenting skills. Each module starts with a survey and feedback to help identify relative strengths and challenges with the targeted parenting skills. Parents are then guided through various online activities including videos that model right and wrong ways to handle comm on situations and explanations of parental self-management and problem-solving strategies. Parents are complete activities to practice the parenting skills taught. Parents will have access to the online program for 8 and they are encouraged to practice the program strategies during this time period. At the end of the 8 weeks, parent re-complete the brief questions that they filled out at the beginning of each module and then receive feedback indicating which of the parent's domain scores have improved since they completed each module.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Parental Monitoring	Parent self-report of monitoring, range 1-5, higher values = better outcome	3 months
Positive Parenting	Parent self-report of positive parenting practices, range 1-5, higher values = better outcome	3 months
Harsh Parenting	Parent self-report of harsh parenting, range 1-5, higher values = worse outcome	3 months
Parental Confidence	Parent self-report of confidence with various parenting strategies, range 1-5, higher values = better outcome	3 months
Child Anger	Parent report of their child's anger, range 1-5, higher values = worse outcome	3 months
Child Oppositional Defiance	Parent report of their child's oppositional defiant behavior, range 1-5, higher values = worse outcome	3 months
Child Callous-Unemotional Traits	Parent report of their child's callousness, range 1-5, higher values = worse outcome	3 months
Child Aggression	Parent report of their child's aggression, range 1-5, higher values = worse outcome	3 months
Child School Performance	Parent report of their child's school performance, range 1-5, higher values = better outcome	3 months
Child Stress	Parent report of child's stress with PROMIS scale, range 1-5, higher values = worse outcome	3 months
Child Anxiety	Parent report of child's anxiety with PROMIS scale, range 1-5, higher values = worse outcome	3 months
Child Depression	Parent report of child's depression with PROMIS scale, range 1-5, higher values = worse outcome	3 months
Family Conflict	Parent report of family conflict including arguing and fighting, range 1-5, higher values = worse outcomes	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Anxiety	Parent self-report of anxiety with PROMIS scale, range 1-5, higher values = worse outcome	3 months
Parent Depression	Parent self-report of depression with PROMIS scale, range 1-5, higher values = worse outcome	3 months
Parent Stress	Parent self-report of stress with PROMIS scale, range 1-5, higher values = worse outcome	3 months

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Arizona Health Care Cost Containment System

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00017956

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No