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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenting Young Children Check-up (PYCC) | Behavioral | The PYCC intends to motivate parents to learn behavioral parenting strategies to reduce child disruptive behavior. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between baseline and 3-months after |
Inclusion Criteria:
Exclusion Criteria:
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Pediatric primary care clinic; parents that report elevated child disruptive behavior problems
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merrill Palmer Skillman Institute | Detroit | Michigan | 48236 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | score on a scale | Baseline |
|
Adverse event data were collected through study completion, which took approximately 25 minutes at one time point.
The clinicaltrials.gov definition was used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen "Lucy" McGoron | Wayne State University | 313.664.2500 | Lucy.K.McGoron@wayne.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 16, 2020 | Nov 3, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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). | 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. | 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. | Baseline |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 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. | Posted | Count of Participants | Participants | Baseline |
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| 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). | Posted | Mean | Full Range | score on a scale | Baseline |
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| 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). | Posted | Mean | Full Range | score on a scale | Baseline |
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| 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. | Posted | Mean | Full Range | score on a scale | Baseline |
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| 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. | Posted | Count of Participants | Participants | Baseline |
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| 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. | Posted | Count of Participants | Participants | Between baseline and 3-months after |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| Suggested having in-person classes |
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| Suggested changing voice of program narrator |
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