Differential DNA Methylation as a Function of a Parenting Intervention

NCT03374969 | Completed DMC

• 1 other identifier: 511457
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maltreatment, Child

Outcome Measures

Primary Outcomes (1)

• Whole Genome DNA Methylation

  from date of enrollment to 1 month after completing the intervention

Secondary Outcomes (1)

• Parental Sensitivity

  On date of enrollment, each intervention session, and 1 month after completing the intervention

Study Arms (2)

Attachment and Biobehavioral Catch-Up

EXPERIMENTAL

Behavioral: Attachment and Biobehavioral Catch-Up

Developmental Education for Families

ACTIVE COMPARATOR

Behavioral: Developmental Education for Families

Interventions

Attachment and Biobehavioral Catch-Up BEHAVIORAL

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.

Attachment and Biobehavioral Catch-Up

Developmental Education for Families BEHAVIORAL

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.

Developmental Education for Families

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Unidel Amy Elizabeth du Pont Chair in Child Development, Director of Clinical Training

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: December 9, 2013
• Primary Completion: December 16, 2014
• Study Completion: February 10, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12