Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652880
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Digital Support Intervention for Pregnant People with Opioid Use Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploring the Preliminary Effects of a Digital Parenting and Recovery Support Intervention for Pregnant People Seeking Recovery from Opioid Use Disorders a Pilot Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARENTSS
Brief Summary:
The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology eg smartphones The main question it aims to answer is
What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities
o Feasibility data includes data on study interest eligibility time to enroll participant training on digital app usage attrition
Secondary outcome exploratory data will include MOUD treatment retention missed follow up prenatal and early postpartum appointments drug usage and parenting outcomes ie scores on the Parental sense of competency scale Self-rated abilities for health practices scale and Self-efficacy in infant care scale through self-report The intervention group only will also be observed regarding app usage frequency of use resources accessed thoughts about the app and what was found to be helpful
Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes
Participants will complete the following tasks
Schedule an online meeting with the research team to receive more information about the study Once consented to participate the participant will be randomly assigned to one of the groups
Complete survey questions within one week after agreeing to participate in the study after 6 weeks and 12 weeks The surveys include questions about drug usage missed follow-up medical appointments and parenting outcomes The total time to complete the survey after consenting to be in the study will take approximately 40 minutes The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes
Complete a one-hour virtual interview at three months post-delivery by phone or computer about the study experience
What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities
o Feasibility data includes data on study interest eligibility time to enroll participant training on digital app usage attrition
Secondary outcome exploratory data will include MOUD treatment retention missed follow up prenatal and early postpartum appointments drug usage and parenting outcomes ie scores on the Parental sense of competency scale Self-rated abilities for health practices scale and Self-efficacy in infant care scale through self-report The intervention group only will also be observed regarding app usage frequency of use resources accessed thoughts about the app and what was found to be helpful
Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes
Participants will complete the following tasks
Schedule an online meeting with the research team to receive more information about the study Once consented to participate the participant will be randomly assigned to one of the groups
Complete survey questions within one week after agreeing to participate in the study after 6 weeks and 12 weeks The surveys include questions about drug usage missed follow-up medical appointments and parenting outcomes The total time to complete the survey after consenting to be in the study will take approximately 40 minutes The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes
Complete a one-hour virtual interview at three months post-delivery by phone or computer about the study experience
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None