Disruptive Behavior DisordersNCT04113304
The Parenting Young Children Check-up: Proof-of-Concept Trial
An observational study of Disruptive Behavior Disorders, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Disruptive Behavior Disorders
- What is being tested?
- Parenting Young Children Check-up (PYCC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 4 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Pediatric primary care clinic; parents that report elevated child disruptive behavior problems
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Merrill Palmer Skillman Institute
Detroit, Michigan, 48236
About this study
Official title: Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors
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.
- Conditions
- Disruptive Behavior Disorders
- Being tested
- Parenting Young Children Check-up (PYCC)
- Keywords
- Parenting Interventions, Parent Training, Technology-based intervention, Disruptive Behavior Problems, Early Childhood
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Young Children Check-up (PYCC)Behavioural
The PYCC intends to motivate parents to learn behavioral parenting strategies to reduce child disruptive behavior.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (4)
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).
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start22 Oct 2019
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disruptive Behavior DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy (Kathleen) McGoron, Ph.D., Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113304
- Sponsor's protocol ID
- K01MH110600
- Status last verified
- Mar 2022
- First submitted
- 27 Jun 2019
- Last updated
- 24 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors
- ClinicalTrials.gov ID
- NCT04113304
- Acronym / sponsor ID
- K01MH110600
- Conditions
- Disruptive Behavior Disorders
- Keywords
- Parenting Interventions, Parent Training, Technology-based intervention, Disruptive Behavior Problems, Early Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 24 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pediatric primary care clinic; parents that report elevated child disruptive behavior problems
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting Young Children Check-up (PYCC)The PYCC intends to motivate parents to learn behavioral parenting strategies to reduce child disruptive behavior. | Behavioural | – |
Primary outcome
Intentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative
Time frame: 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.
Intentions to Use the Parenting Young Children Check-up Web-based Resource: Qualitative
Time frame: 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.
4 secondary outcomes
Perceived Ease of Use of the Parenting Young Children Check-up Program
Time frame: Baseline
Perceived Usefulness of the Parenting Young Children Check-up Program
Time frame: Baseline
Likeability of the Parenting Young Children Check-up Program
Time frame: Baseline
Suggestions for Program Improvements
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disruptive Behavior Disorders, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.