Differential DNA Methylation as a Function of a Parenting Intervention

Differential DNA Methylation as a Function of a Parenting Intervention: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Maltreatment, Child
• Intervention / Treatment: Behavioral: Attachment and Biobehavioral Catch-Up; Behavioral: Developmental Education for Families

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attachment and Biobehavioral Catch-Up	Behavioral: Attachment and Biobehavioral Catch-Up; Attachment and Biobehavioral Catch-up (ABC) is a 10-session, weekly intervention delivered in the family's home. ABC addresses three primary issues. First, young children who have experienced early adversity are especially in need of nurturance and parents who behave in synchronous ways and delight in them. Next, when parents behave in frightening ways, it is difficult for children to look to them for reassurance when distressed. This can be particularly difficult for children who have experienced early adversity. Therefore, this intervention helps parents learn how to: 1) behave in nurturing ways when children are distressed; 2) behave in synchronous, delighted ways when children are not distressed; and 3) avoid behaving in frightening or intrusive ways. Interventionists are provided with a manualized protocol, but tailor specific session content to each family's needs. Sessions are videotaped, both for playback to families, and for supervision.
Active Comparator: Developmental Education for Families	Behavioral: Developmental Education for Families; Developmental Education for Families (DEF) is a 10-session, weekly intervention delivered in the family's home. DEF focuses on enhancing gross and fine motor skills, cognition and language development. The age-based protocols (i.e., 6-24 months,) provide information about the developmental themes of focus for each week and suggest activities to enhance the target skills for that week. However, the protocols do not provide a direct script with which to conduct the sessions. Interventionists tailor the developmental program session to the needs of the child and family by considering the child's current gross, fine, cognitive and language skills and creatively preparing several activities that will address the session topics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whole Genome DNA Methylation	from date of enrollment to 1 month after completing the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Parental Sensitivity	On date of enrollment, each intervention session, and 1 month after completing the intervention

Collaborators and Investigators

• Sponsor: University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2013
• Primary Completion (Actual): December 16, 2014
• Study Completion (Actual): February 10, 2017

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 511457

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No