Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113304
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Lucy (Kathleen) McGoron, Ph.D., Wayne State University

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
Disruptive Behavior Disorders Behavioral: Parenting Young Children Check-up (PYCC)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting


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


Primary Outcome Measures :
  1. Perceived ease of use of the Parenting Young Children Check-up Program [ Time Frame: Baseline ]

    Five questionnaire items (created for this project) will tap into this outcome. Parents will be asked about perceived ease of use of each part of the program. Items will be rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores will indicate more perceived ease of use. Responses (n and % for each response option) will be reported for each item. Additionally, an average ease of use score will be computed by taking the mean of the 5 responses (range of 0 [Definitely Disagree] to 4 [Definitely Agree]; higher scores indicate more ease of use).

    Additionally, two oral interview questions will tap into perceived ease of use. These oral items will be coded for specific comments related to ease of use.


  2. Perceived usefulness of the information in the Parenting Young Children Check-up Program [ Time Frame: Baseline ]

    Seven questionnaire items (created for this project) will tap into this outcome. Parents will be asked about how useful they perceive each part of the program. Items will be rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores will indicate more perceived usefulness. Responses (n and % for each response option) will be reported for each item. Additionally, an average perceived usefulness score will be computed by taking the mean of the 7 responses (range of 0 [Definitely Disagree] to 4 [Definitely Agree]; higher scores indicate more perceived usefulness).

    Additionally, two oral interview questions will tap into perceived usefulness. These oral items will be coded for specific comments related to usefulness of the program.


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

    Four questionnaire items (created for this project) will tap into this outcome. Parents will be asked about how much they like each part of the program. Items will be rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores will indicate more likability. Responses (n and % for each response option) will be reported for each item. Additionally, an average likability score will be computed by taking the mean of the 4 responses (range of 0 [Definitely Disagree] to 4 [Definitely Agree]; higher scores indicate more likability).

    Additionally, two oral interview questions will tap into perceived usefulness. These oral items will be coded for specific comments related to likability of the program.


  4. Intentions to use the Parenting Young Children Check-up web-based resource [ Time Frame: Baseline ]
    Two questionnaire items (created for this project) will tap into this outcome. Parents will be asked about their intentions to use the web-based resource (i.e., videos on the website). For each of the two items, responses will be on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree). Responses (n and % for each response option) will be reported for each item. Additionally, one oral questionnaire item will tap into this outcome; coding will reflect what percent of parents are 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.

  5. Suggestions for program improvements [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of participants that use the web-based parent training resources [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Pediatric primary care clinic; parents that report elevated child disruptive behavior problems
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113304


Contacts
Layout table for location contacts
Contact: Lucy McGoron, Ph.D. 313-664-2553 Lucy.K.McGoron@wayne.edu

Locations
Layout table for location information
United States, Michigan
Merrill Palmer Skillman Institute Recruiting
Detroit, Michigan, United States, 48236
Contact: Lucy Kathleen McGoron, Ph.D.    313-664-2553    Lucy.K.McGoron@wayne.edu   
Sponsors and Collaborators
Wayne State University

Layout table for additonal information
Responsible Party: Lucy (Kathleen) McGoron, Ph.D., Assistant Professor (Research), Wayne State University
ClinicalTrials.gov Identifier: NCT04113304    
Other Study ID Numbers: K01MH110600 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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., Wayne State University:
Parenting Interventions
Parent Training
Technology-based intervention
Disruptive Behavior Problems
Early Childhood
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders