Ignite Creation Date:
2024-05-06 @ 9:18 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02955199
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2016-10-27
Brief Title:
Stage III Community-based Efficacy Trial for Mothering From the Inside Out
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Fostering Mothers Emotionally-Responsive Parenting A Stage III Community-Based Efficacy Trial
Status:
COMPLETED
Status Verified Date:
2021-07
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:
This is a Stage III community-based randomized clinical efficacy trial testing Mothering from the Inside Out MIO the first evidence-based parenting intervention designed to be delivered by addiction counselors in addiction treatment settings where parents of young children are enrolled in treatment
Detailed Description:
This is a new Stage III community-based randomized clinical efficacy trial testing Mothering from the Inside Out MIO the first evidence-based parenting intervention designed to be delivered by addiction counselors in addiction treatment settings where parents of young children are enrolled in treatment MIO is a weekly individual parenting therapy developed as an enhancement to standard addiction treatment that targets the addicted mothers capacity to recognize and regulate her own emotional distress during stressful parenting situations so that she can support her childs developing capacity for emotional and behavioral regulation This capacity called reflective functioning RF is a psychological skill that promotes abstinence and also helps parents foster their young childrens secure attachment Now that MIO has demonstrated efficacy in two randomized efficacy trials the next step will be to conduct a new Stage III community-based efficacy trial where addiction counselors are trained to deliver MIO and PE with fidelity in an addiction treatment setting and to evaluate treatment outcomes and mechanisms of change in this community setting At the end of this trial if MIO demonstrates efficacy all the necessary materials will be ready to train addiction counselors across a broad range of treatment settings in a Stage IV effectiveness trial 120 mothers in addiction treatment and caring for children ages 11 - 60 months will be randomized to 12 sessions of MIO vs PE with a trained addiction counselor and fidelity will be monitored and maintained for treatment duration It is expected that MIO-assigned mothers will demonstrate greater improvement in the primary targeted outcome - reflective functioning at week 12 end of treatment and week 33 end of follow up It is also predicted that MIO-assigned mothers will demonstrate greater improvement in secondary outcomes including maternal sensitivity caregiving behavior psychiatric distress depression and substance use at week 12 end of treatment and week 33 end of follow up Finally it is predicted that children of MIO-assigned mothers will demonstrate greater improvement in the secondary outcome - attachment security - at week 12 end of treatment and week 33 end of follow up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01DA017294 | NIH | None | httpsreporternihgovquickSearch3R01DA017294 |