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

• Sponsor: Wayne State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04113304
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disruptive Behavior Disorders	Behavioral: Parenting Young Children Check-up (PYCC)

Study Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors
• Actual Study Start Date: Oct 22, 2019
• Actual Primary Completion Date: Mar 4, 2020
• Actual Study Completion Date: Mar 4, 2020

Outcome Measures

Primary Outcome Measures

1. Intentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative [Baseline]

   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.

2. Intentions to Use the Parenting Young Children Check-up Web-based Resource: Qualitative [Baseline]

   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.

Secondary Outcome Measures

1. Perceived Ease of Use of the Parenting Young Children Check-up Program [Baseline]

   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).

2. Perceived Usefulness of the Parenting Young Children Check-up Program [Baseline]

   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).

3. Likeability of the Parenting Young Children Check-up Program [Baseline]

   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.

4. Suggestions for Program Improvements [Baseline]

   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.

Other Outcome Measures

1. Number of Participants That Use the Web-based Parent Training Resources [Between baseline and 3-months after]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merrill Palmer Skillman Institute	Detroit	Michigan	United States	48236

Sponsors and Collaborators

• Wayne State University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 16, 2020

More Information

Publications

None provided.

• Responsible Party: Lucy (Kathleen) McGoron, Ph.D., Assistant Professor (Research), Wayne State University
• ClinicalTrials.gov Identifier: NCT04113304
• Other Study ID Numbers: K01MH110600
• First Posted: Oct 2, 2019
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lucy (Kathleen) McGoron, Ph.D., Assistant Professor (Research), Wayne State University: Parenting Interventions; Parent Training; Technology-based intervention; Disruptive Behavior Problems; Early Childhood
• Additional relevant MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders

Study Results

Participant Flow

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Overall Participants	6
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	27.83
Sex: Female, Male (Count of Participants)
Female	6 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 83.3%
White	0 0%
More than one race	1 16.7%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
Mean (Full Range) [score on a scale]	3.25

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
Reported intentions to use program	6 100%
Did not report intention to use program	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
Mean (Full Range) [score on a scale]	3.40

4. Secondary Outcome

Title	Perceived Usefulness of the Parenting Young Children Check-up Program
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
Mean (Full Range) [score on a scale]	3.52

5. Secondary Outcome

Title	Likeability of the Parenting Young Children Check-up Program
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
Mean (Full Range) [score on a scale]	3.63

6. Secondary Outcome

Title	Suggestions for Program Improvements
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
No changes suggested	2 33.3%
Suggested adding captioning to videos	1 16.7%
Suggested giving out a pamphlet for the program	1 16.7%
Suggested having in-person classes	1 16.7%
Suggested changing voice of program narrator	1 16.7%

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Measure Participants	6
Used web-based resource	0 0%
Did not use web-based resource	6 100%

Adverse Events

Time Frame	Adverse event data were collected through study completion, which took approximately 25 minutes at one time point.
Adverse Event Reporting Description	The clinicaltrials.gov definition was used.
Arm/Group Title	Intervention
Arm/Group Description	Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.