Clinical trial NCT04113304: The Parenting Young Children Check-up: Proof-of-Concept Trial
Official title: Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disruptive Behavior Disorders
Keywords: Parenting Interventions
Parent Training
Technology-based intervention
Disruptive Behavior Problems
Early Childhood
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric primary care clinic; parents that report elevated child disruptive behavior problems

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative
timeFrame: Baseline
measure: Intentions to Use the Parenting Young Children Check-up Web-based Resource: Qualitative
timeFrame: Baseline
Secondary outcomes:
measure: Perceived Ease of Use of the Parenting Young Children Check-up Program
timeFrame: Baseline
measure: Perceived Usefulness of the Parenting Young Children Check-up Program
timeFrame: Baseline
measure: Likeability of the Parenting Young Children Check-up Program
timeFrame: Baseline
measure: Suggestions for Program Improvements
timeFrame: Baseline
Other outcomes:
measure: Number of Participants That Use the Web-based Parent Training Resources
timeFrame: Between baseline and 3-months after
Locations:
city: Detroit
country: United States
facility: Merrill Palmer Skillman Institute
state: Michigan
Study officials:
References: