Family Check-Up Online

NCT06161597 | Active Not Recruiting

• 1 other identifier: STUDY00017956
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Families of Middle School Students at Title 1 Schools

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (3)

• Parent Anxiety

  3 months

• Parent Depression

  3 months

• Parent Stress

  3 months

Study Arms (2)

Informational Support

EXPERIMENTAL

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

Guidance Coaching

EXPERIMENTAL

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

Interventions

Family Check-Up Online BEHAVIORAL

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.

Guidance Coaching; Informational Support

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Arizona State University: lead
• Arizona Health Care Cost Containment System: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study personnel and participants are informed of what condition participants are assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the primary intervention: The Family Check-Up Online. Participants will then be randomly assigned to a specific coaching condition.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 8, 2023
• Study Start: October 25, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)