Clinical trial NCT04628546: The Parenting Young Children Check-up Evaluation
Official title: Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors: Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior
Parenting
Keywords: Parenting Interventions
Parent Training
Preschool-aged Children
Technology-based intervention
Brief Intervention
Disruptive Behavior Problems
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty parents that will be randomly assigned to the intervention group (random assignment determined through a random number generator). Twenty parents will be assigned to a control condition.
Primary purpose: TREATMENT

Brief summary: The PYCC is a system for parents of young children (2-5 years old) with Disruptive Behavior Problems (DBPs). The program is designed with the intentions of being used a pediatric primary care visit. Parents that report elevated child behavior problems go through a three part program. First, they go through a brief intervention on a tablet (i.e., the initial check-up) to receive feedback and learn about the PYCC; the aim is to build motivation to make parenting changes and engage in the parenting young children check-up. Next, parents receive text messages to connect them to further parent training content. Finally, parent training content is delivered via a web-based resource (i.e., the PYCC website), which includes videos to teach parenting skills. In this pilot RCT, the investigators will focus on examining the impact of the brief intervention (i.e., the initial check-up). Secondarily, the investigators will examine overall impact of the whole PYCC program and use of the parenting training website.

Parents will learn about the research opportunity through select community-based organizations in Detroit, Michigan, local posting, and a local participant registry. Through a phone call, parents will complete a demographics questionnaire and the DBP screener. The investigators aim to screen 200 parents in order to enroll 40 parents in the clinical trial.

If parents report elevated DBPs and do not meet any exclusion criteria, then they will be eligible to further participate. Parents that are eligible will complete a consent form (i.e., an online information sheet) and then be randomly assigned to intervention (n = 20) or control (n = 20). Both groups will complete a brief baseline. Both groups will also learn about the Parenting Young Children Check-up (PYCC). However, the way in which they learn about the program will differ. The control group will see a brief description about the program (i.e., an online flier) and will receive a brochure for the program through the mail. The intervention group will go through the full PYCC initial check-up and also receive a brochure through the mail. Both groups will receive text messages prompting them to engage in the PYCC.

After initial participation, parents will be free to use, or not use, the Parenting Young Children Check-up web-based resource as much as they want. Parents will enter their phone number and first name when accessing the web-based content in order for use to track their engagement. All use of the web-based resource will start with "Session 1. In this, they will choose what parenting skills they want to learn. If parents go through session 1, they will be further connected to PYCC content through tailored text messages. Texts contain links to all PYCC web-based content. Parents will be able to learn content related to "Special Time," "Labeled Praise," "Family Rules," "Effective Commands," "Offering Choices," "Routines," "Removing Attention," "Logical Consequences," and "Time out." All content of the PYCC is based on evidence-based parent training program content.

The purpose of this project is evaluate the Parenting Young Children Check-up. In particular, the investigators are interested in if the initial check-up leads parents to engage in the PYCC (i.e., completing session 1 and using the parent training content on the PYCC website).

Hypotheses include:

Primary Hypothesis: The intervention group (i.e. those randomized to complete the full initial check-up) will visit the parent training website more than the control group. The investigators hypothesize that, compared to the control group, more parents in the control group with complete "session 1," and use the PYCC web-based content to learn parenting skills (i.e., more parents will use any of this content and parents will use it more frequently).

Secondary Hypothesis (a): Participants assigned to the intervention group, as compared to those in the control group, will have higher scores for all domains consistent with the Theory of Planned Behavior at follow-up.

Secondary Hypothesis (b). Participants in the intervention group will report high levels of satisfaction (i.e., \>=4 on a 5-point scale).

The investigators will also explore the impact of the PYCC on reported parenting and child behavior problems. Furthermore, the investigators will explore the impact of the initial check-up on intentions to use the parent training website.


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
* Have Smartphone and CIAS program works on their phone

Exclusion Criteria:

* Parent report that their child has an Autism Spectrum Disorder diagnosis
* Parent report that their child has an intellectual disability
* Parent report that their child is receiving treatment of Oppositional Defiant Disorder or ADHD

Primary outcomes:
measure: Initial use of the parenting training website session 1
timeFrame: 1 month
measure: Use of parent training content on the PYCC website (binary; yes or no)
timeFrame: 1 month
measure: Number of uses of parent training content on the PYCC website
timeFrame: 1 month
measure: Use of parent training content on the PYCC website (binary; yes or no)
timeFrame: 3 months
measure: Number of uses of parent training content on the PYCC website
timeFrame: 3 months
Secondary outcomes:
measure: Change in Attitudes, norms, and perceived behavioral control; consistent with the Theory of Planned Behavior
timeFrame: Baseline; 1 month
measure: Change in Attitudes, norms, and perceived behavioral control; consistent with the Theory of Planned Behavior
timeFrame: Baseline; 3 months
measure: Technology Acceptance with initial check-up
timeFrame: Baseline;
measure: Technology Acceptance Parenting Young Children Check-up
timeFrame: 1 month
Other outcomes:
measure: Change in Child Disruptive Behavior Intensity
timeFrame: Baseline; 1 month; 3 month
measure: Change in Child Disruptive Behavior Intensity
timeFrame: Baseline; 3 month
measure: Change in Child Disruptive Behavior Problems Count
timeFrame: Baseline; 1 month
measure: Change in Child Disruptive Behavior Problems Count
timeFrame: Baseline; 3 months
measure: Change in Parenting
timeFrame: Baseline; 1 months
measure: Change in Parenting
timeFrame: Baseline; 3 months
measure: Intentions to use the PYCC parent training website
timeFrame: Baseline
Locations:
city: Detroit
country: United States
facility: Merrill Palmer Skillman Institute
state: Michigan
Study officials:
References: