Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT03374969
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differential DNA Methylation as a Function of a Parenting Intervention
Sponsor:
University of Delaware
Organization:
Study Overview
Official Title:
Differential DNA Methylation as a Function of a Parenting Intervention: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-12
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 aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health.
Detailed Description:
This study assesses whether a 10-session intervention for maltreating parents effects the epigenome of young children who have experienced early maltreatment. Families are randomly assigned to the experimental condition (Attachment and Biobehavioral Catch-Up) or a treatment control (Developmental Education for Families). Biological samples and behavioral observations of parenting will be collected pre- and post- intervention. Biological samples will be used to conduct whole genome analyses of differential DNA methylation that occur as a result of the intervention. Behavioral observations of parent-child interactions will be used to assess the efficacy of the intervention in altering parenting behaviors.
Study Oversight
Has Oversight DMC:
True
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?: