The Parenting Young Children Check-up: Proof-of-Concept Trial

NCT04113304 | Completed Results

• 1 other identifier: K01MH110600
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The Parenting Young Children Check-up (PYCC) is a 3-part system for parents of children with Disruptive Behavior Problems (DBPs). First, at a pediatric visit, parents complete a screener for DBPs and, if reported, go through a tablet-based program to receive feedback and learn about the PYCC. Next, parents receive text messages to connect them to further parent training content. Third, parent training content is delivered via a web-based resource, which includes videos to teach parenting skills. In this proof-of-concept trial, the investigators will examine the acceptability of the tablet-based program and motivation of parents to engage in the PYCC and use the web-based resource. At a pediatric visit, parents will be told about the research opportunity by a staff member before, during, or after their visit. There will be a flier for parents, which will be available for receptionists to include with in-take paperwork. If parents express openness to participating, a research assistant will meet with them, go over the consent form, and let them complete the screener. Parents will complete a demographics questionnaire and the DBP screener. If parents report elevated DBPs, then they will be eligible to further participate. If they are eligible and choose to participate, the research assistant will have them go through the tablet-based program. Next, they will complete a brief questionnaire asking for input on the PYCC. Each of these components will be completed in the Computerized Intervention Authoring System (CIAS). The brief questionnaire is intended to evaluate perceptions of 1) ease of use, 2) usefulness of the information, 3) likability, and 4) intentions to use the PYCC web-based resource. Items will be rated on a 0 (strongly disagree) to 4 (strongly agree) scale. Parents will also verbally answer 6 open-ended interview questions about the program and suggest improvements. Answers will be audio-recorded and transcribed. All participants (whether only completing the screening or both parts of the study) will receive a resource list as well as a list of URLs to access videos on the video-based content on PYCC website. An ID number will need to be entered to use the website and the investigators will track website use. This data collection is not hypothesis driven. Rather, the intent is to gather mixed methods feedback from parents to shape the PYCC program.

Conditions

Disruptive Behavior Disorders

Keywords

Parenting Interventions; Parent Training; Technology-based intervention; Disruptive Behavior Problems; Early Childhood

Outcome Measures

Primary Outcomes (2)

• Intentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative

  Two items (created for this project) were used to assess this outcome. Parents were asked their intentions to use the web-based resource (i.e., videos on the website). Items were rated on 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree). To create the final score, the two items were averaged with a possible range from 0-4 with higher scores indicating stronger intentions to use the Parenting Young Children Check-up web-based resource.

  Baseline

• Intentions to Use the Parenting Young Children Check-up Web-based Resource: Qualitative

  One oral question, asking if parents intent to use the Parenting Young Children Check-up web-based resource, tapped into this outcome. Responses from participants were coded to reflect what percent of parents were interested in using the web-based resource, what percent of parent are not interested in using the web-based resource, and what percent are unsure.

  Baseline

Secondary Outcomes (4)

• Perceived Ease of Use of the Parenting Young Children Check-up Program

  Baseline

• Perceived Usefulness of the Parenting Young Children Check-up Program

  Baseline

• Likeability of the Parenting Young Children Check-up Program

  Baseline

• Suggestions for Program Improvements

  Baseline

Other Outcomes (1)

• Number of Participants That Use the Web-based Parent Training Resources

  Between baseline and 3-months after

Interventions

Parenting Young Children Check-up (PYCC) BEHAVIORAL

The PYCC intends to motivate parents to learn behavioral parenting strategies to reduce child disruptive behavior.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric primary care clinic; parents that report elevated child disruptive behavior problems

You may qualify if:

• Age 18 or above
• English speaking
• Parent to a child ages 2-5
• Report their child has elevated disruptive behavior problems on the Eyberg Child Behavior Inventory

You may not qualify if:

• Parent reports child has Autism Spectrum Disorder
• Parent reports child has an intellectual disability
• Parent reports child is receiving treatment for Oppositional Defiant Disorder or Attention Deficit Hyperactivity Disorder

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Merrill Palmer Skillman Institute

Detroit, Michigan, 48236, United States

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Kathleen "Lucy" McGoron
• Organization: Wayne State University

Lucy.K.McGoron@wayne.edu

313.664.2500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research)

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: October 2, 2019
• Study Start: October 22, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)