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

Disruptive Behavior Disorders Clinical Trial

Official title:

Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113304
• Other study ID #: K01MH110600
• Status: Completed
• Start date: October 22, 2019
• Est. completion date: March 4, 2020

Study information

• Verified date: March 2022
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Disruptive Behavior Disorders
• Mental Disorders
• Problem Behavior

Intervention

Behavioral:
• Parenting Young Children Check-up (PYCC)
The PYCC intends to motivate parents to learn behavioral parenting strategies to reduce child disruptive behavior.

Locations

Country	Name	City	State
United States	Merrill Palmer Skillman Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants That Use the Web-based Parent Training Resources	All participating parents will have an ID to access web-based parent training resources. The investigators will track to see who makes use of the resources; the frequency of use (n and % of families that use the web-based resource) will be reported.	Between baseline and 3-months after
Primary	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
Primary	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	Perceived Ease of Use of the Parenting Young Children Check-up Program	Five questionnaire items (created for this project) were used to assess this outcome. Parents were asked about perceived ease of use of each part of the program. Each of the 5 items were rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores indicate more perceived ease of use. An average ease of use score was computed by averaging the responses to the 5 items; the possible range was from 0-4 with higher scores indicate more ease of use).	Baseline
Secondary	Perceived Usefulness of the Parenting Young Children Check-up Program	Seven questionnaire items (created for this project) were used to assess this outcome. Parents were asked about perceived usefulness of each part of the program. Each of the 5 items were rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores indicate more perceived ease of use. An average usefulness score was computed by averaging the responses to the 5 items; the possible range was from 0-4 with higher scores indicate more ease of use).	Baseline
Secondary	Likeability of the Parenting Young Children Check-up Program	Four questionnaire items (created for this project) tapped into this outcome. Parents were asked about how much they like each part of the program. Items were rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher score indicated more likability. An average likability score was computed by taking the average of the 4 responses; possible range from 0-4 with higher scores indicate more likability.	Baseline
Secondary	Suggestions for Program Improvements	One oral interview question ("Tell me your ideas about how to make the program better?') will tap into this outcome. Responses will be coded for specific suggestions to improve the Parenting Young Children Check-up program.	Baseline