Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273228
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Brief Title:
Parenting Young Children in Pediatrics
Sponsor:
University of Oregon
Organization:
University of Oregon
Study Overview
Official Title:
An Online Parenting Intervention for Families Affected by Substance Misuse in Pediatric Primary Care
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Research suggests that one in eight children in the US currently lives with a parent with a substance use disorder Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances Interventions must be convenient non-stigmatizing and accessible to parents with problematic substance use who frequently face barriers to engaging with healthcare systems Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their childs pediatrician
The Family Check-Up FCU Online app which was created specifically to promote positive parenting skills in parents with past or current substance misuse is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief convenient and delivered in a self-directed format that parents favor The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online a brief app-based parenting intervention for parents reporting lifetime problematic substance use in a pediatric primary care setting
In this study investigators will partner with pediatric primary care providers to recruit parent participants then evaluate feasibility and acceptability by systematically assessing parents engagement with the FCU Online app Engagement data from the app includes time spent in app overall and in each module activities completed and which modules were accessed Investigators will also administer a consumer satisfaction survey which will ask parents to report on their perceptions of the app eg helpfulness useability and effects on parenting To assess engagement in telehealth coaching sessions investigators will use the following variables number of telehealth sessions completed length of session content of sessions and coaches ratings of participant engagement in the session and barriers to using the app Coaches will also rate participant engagement on a 3-point scale from low to high Lastly investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting
A second aim of this study is to assess pediatric healthcare providers perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings
The Family Check-Up FCU Online app which was created specifically to promote positive parenting skills in parents with past or current substance misuse is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief convenient and delivered in a self-directed format that parents favor The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online a brief app-based parenting intervention for parents reporting lifetime problematic substance use in a pediatric primary care setting
In this study investigators will partner with pediatric primary care providers to recruit parent participants then evaluate feasibility and acceptability by systematically assessing parents engagement with the FCU Online app Engagement data from the app includes time spent in app overall and in each module activities completed and which modules were accessed Investigators will also administer a consumer satisfaction survey which will ask parents to report on their perceptions of the app eg helpfulness useability and effects on parenting To assess engagement in telehealth coaching sessions investigators will use the following variables number of telehealth sessions completed length of session content of sessions and coaches ratings of participant engagement in the session and barriers to using the app Coaches will also rate participant engagement on a 3-point scale from low to high Lastly investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting
A second aim of this study is to assess pediatric healthcare providers perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings
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