Differential DNA Methylation as a Function of a Parenting Intervention

Not Applicable

Completed

• Conditions: Maltreatment, Child
• Interventions: Behavioral: Developmental Education for Families; Behavioral: Attachment and Biobehavioral Catch-Up

• Registration Number: NCT03374969
• Lead Sponsor: University of Delaware

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 Timeline

• Study Start: 2013-12-09
• Primary Completion: 2014-12-16
• Study Completion: 2017-02-10
• Status Verified: 2017-12
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Parents will be considered potentially eligible if they have a child between the ages of 6 and 20 months and have a history of substantiated or unsubstantiated report of maltreatment or domestic violence. After obtaining informed consent, observational assessments of sensitivity will be conducted, allowing screening of parents with low levels of sensitivity (who are expected to benefit more from the intervention than others). Only those parents who have scores in the insensitive range will be included in the full study.

Exclusion Criteria

• Children with known serious medical issues (e.g., cerebral palsy) will be excluded from the sample. Also, high-risk parents will be screened for sensitivity to ensure that they will benefit from the intervention. Only those who are screened as relatively insensitive (1-2 on a 5 point coding scale) will be included in the full study.
• If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
• If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Developmental Education for Families	Developmental Education for Families	-
Attachment and Biobehavioral Catch-Up	Attachment and Biobehavioral Catch-Up	-

Primary Outcome Measures

Name	Time	Method
Whole Genome DNA Methylation	from date of enrollment to 1 month after completing the intervention

Secondary Outcome Measures

Name	Time	Method
Parental Sensitivity	On date of enrollment, each intervention session, and 1 month after completing the intervention