Status:
COMPLETED
Differential DNA Methylation as a Function of a Parenting Intervention
Lead Sponsor:
University of Delaware
Conditions:
Maltreatment, Child
Eligibility:
All Genders
6-24 years
Phase:
NA
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 a...
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 exp...
Eligibility Criteria
Inclusion
- 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
- 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- If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
- If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.
Key Trial Info
Start Date :
December 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03374969
Start Date
December 9 2013
End Date
February 10 2017
Last Update
December 19 2017
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