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

Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04113304
Enrollment
6
Registered
2019-10-02
Start date
2019-10-22
Completion date
2020-03-04
Last updated
2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disruptive Behavior Disorders

Keywords

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

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.

Interventions

BEHAVIORALParenting Young Children Check-up (PYCC)

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

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Intentions to Use the Parenting Young Children Check-up Web-based Resource: QualitativeBaselineOne 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.
Intentions to Use the Parenting Young Children Check-up Web-based Resource: QuantitativeBaselineTwo 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.

Secondary

MeasureTime frameDescription
Perceived Usefulness of the Parenting Young Children Check-up ProgramBaselineSeven 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).
Suggestions for Program ImprovementsBaselineOne 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.
Likeability of the Parenting Young Children Check-up ProgramBaselineFour 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.
Perceived Ease of Use of the Parenting Young Children Check-up ProgramBaselineFive 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).

Other

MeasureTime frameDescription
Number of Participants That Use the Web-based Parent Training ResourcesBetween baseline and 3-months afterAll 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
6
Total6

Baseline characteristics

CharacteristicIntervention
Age, Continuous27.83 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
5 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
6 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 6
other
Total, other adverse events
0 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

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.

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionIntentions to Use the Parenting Young Children Check-up Web-based Resource: QualitativeReported intentions to use program6 Participants
InterventionIntentions to Use the Parenting Young Children Check-up Web-based Resource: QualitativeDid not report intention to use program0 Participants
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.

Time frame: Baseline

ArmMeasureValue (MEAN)
InterventionIntentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative3.25 score on a scale
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.

Time frame: Baseline

ArmMeasureValue (MEAN)
InterventionLikeability of the Parenting Young Children Check-up Program3.63 score on a scale
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).

Time frame: Baseline

ArmMeasureValue (MEAN)
InterventionPerceived Ease of Use of the Parenting Young Children Check-up Program3.40 score on a scale
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).

Time frame: Baseline

ArmMeasureValue (MEAN)
InterventionPerceived Usefulness of the Parenting Young Children Check-up Program3.52 score on a scale
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.

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionSuggestions for Program ImprovementsNo changes suggested2 Participants
InterventionSuggestions for Program ImprovementsSuggested adding captioning to videos1 Participants
InterventionSuggestions for Program ImprovementsSuggested giving out a pamphlet for the program1 Participants
InterventionSuggestions for Program ImprovementsSuggested having in-person classes1 Participants
InterventionSuggestions for Program ImprovementsSuggested changing voice of program narrator1 Participants
Other Pre-specified

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.

Time frame: Between baseline and 3-months after

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants That Use the Web-based Parent Training ResourcesUsed web-based resource0 Participants
InterventionNumber of Participants That Use the Web-based Parent Training ResourcesDid not use web-based resource6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026