Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628546
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2020-09-28
Brief Title:
The Parenting Young Children Check-up Evaluation
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors Pilot Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The PYCC is a system for parents of young children 2-5 years old with Disruptive Behavior Problems DBPs The program is designed with the intentions of being used a pediatric primary care visit Parents that report elevated child behavior problems go through a three part program First they go through a brief intervention on a tablet ie the initial check-up to receive feedback and learn about the PYCC the aim is to build motivation to make parenting changes and engage in the parenting young children check-up Next parents receive text messages to connect them to further parent training content Finally parent training content is delivered via a web-based resource ie the PYCC website which includes videos to teach parenting skills In this pilot RCT the investigators will focus on examining the impact of the brief intervention ie the initial check-up Secondarily the investigators will examine overall impact of the whole PYCC program and use of the parenting training website
Parents will learn about the research opportunity through select community-based organizations in Detroit Michigan local posting and a local participant registry Through a phone call parents will complete a demographics questionnaire and the DBP screener The investigators aim to screen 200 parents in order to enroll 40 parents in the clinical trial
If parents report elevated DBPs and do not meet any exclusion criteria then they will be eligible to further participate Parents that are eligible will complete a consent form ie an online information sheet and then be randomly assigned to intervention n 20 or control n 20 Both groups will complete a brief baseline Both groups will also learn about the Parenting Young Children Check-up PYCC However the way in which they learn about the program will differ The control group will see a brief description about the program ie an online flier and will receive a brochure for the program through the mail The intervention group will go through the full PYCC initial check-up and also receive a brochure through the mail Both groups will receive text messages prompting them to engage in the PYCC
After initial participation parents will be free to use or not use the Parenting Young Children Check-up web-based resource as much as they want Parents will enter their phone number and first name when accessing the web-based content in order for use to track their engagement All use of the web-based resource will start with Session 1 In this they will choose what parenting skills they want to learn If parents go through session 1 they will be further connected to PYCC content through tailored text messages Texts contain links to all PYCC web-based content Parents will be able to learn content related to Special Time Labeled Praise Family Rules Effective Commands Offering Choices Routines Removing Attention Logical Consequences and Time out All content of the PYCC is based on evidence-based parent training program content
The purpose of this project is evaluate the Parenting Young Children Check-up In particular the investigators are interested in if the initial check-up leads parents to engage in the PYCC ie completing session 1 and using the parent training content on the PYCC website
Hypotheses include
Primary Hypothesis The intervention group ie those randomized to complete the full initial check-up will visit the parent training website more than the control group The investigators hypothesize that compared to the control group more parents in the control group with complete session 1 and use the PYCC web-based content to learn parenting skills ie more parents will use any of this content and parents will use it more frequently
Secondary Hypothesis a Participants assigned to the intervention group as compared to those in the control group will have higher scores for all domains consistent with the Theory of Planned Behavior at follow-up
Secondary Hypothesis b Participants in the intervention group will report high levels of satisfaction ie 4 on a 5-point scale
The investigators will also explore the impact of the PYCC on reported parenting and child behavior problems Furthermore the investigators will explore the impact of the initial check-up on intentions to use the parent training website
Parents will learn about the research opportunity through select community-based organizations in Detroit Michigan local posting and a local participant registry Through a phone call parents will complete a demographics questionnaire and the DBP screener The investigators aim to screen 200 parents in order to enroll 40 parents in the clinical trial
If parents report elevated DBPs and do not meet any exclusion criteria then they will be eligible to further participate Parents that are eligible will complete a consent form ie an online information sheet and then be randomly assigned to intervention n 20 or control n 20 Both groups will complete a brief baseline Both groups will also learn about the Parenting Young Children Check-up PYCC However the way in which they learn about the program will differ The control group will see a brief description about the program ie an online flier and will receive a brochure for the program through the mail The intervention group will go through the full PYCC initial check-up and also receive a brochure through the mail Both groups will receive text messages prompting them to engage in the PYCC
After initial participation parents will be free to use or not use the Parenting Young Children Check-up web-based resource as much as they want Parents will enter their phone number and first name when accessing the web-based content in order for use to track their engagement All use of the web-based resource will start with Session 1 In this they will choose what parenting skills they want to learn If parents go through session 1 they will be further connected to PYCC content through tailored text messages Texts contain links to all PYCC web-based content Parents will be able to learn content related to Special Time Labeled Praise Family Rules Effective Commands Offering Choices Routines Removing Attention Logical Consequences and Time out All content of the PYCC is based on evidence-based parent training program content
The purpose of this project is evaluate the Parenting Young Children Check-up In particular the investigators are interested in if the initial check-up leads parents to engage in the PYCC ie completing session 1 and using the parent training content on the PYCC website
Hypotheses include
Primary Hypothesis The intervention group ie those randomized to complete the full initial check-up will visit the parent training website more than the control group The investigators hypothesize that compared to the control group more parents in the control group with complete session 1 and use the PYCC web-based content to learn parenting skills ie more parents will use any of this content and parents will use it more frequently
Secondary Hypothesis a Participants assigned to the intervention group as compared to those in the control group will have higher scores for all domains consistent with the Theory of Planned Behavior at follow-up
Secondary Hypothesis b Participants in the intervention group will report high levels of satisfaction ie 4 on a 5-point scale
The investigators will also explore the impact of the PYCC on reported parenting and child behavior problems Furthermore the investigators will explore the impact of the initial check-up on intentions to use the parent training website
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01MH110600 | NIH | None | httpsreporternihgovquickSearchK01MH110600 |