Helping opioid-dependent mothers and their infants
Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation
This study tests a new program to help opioid-dependent mothers improve their parenting skills and support their infants' development during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT04454645 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a modified intervention designed to improve parenting skills and infant development among opioid-dependent mothers receiving medication-assisted treatment. Pregnant women in their third trimester will be randomly assigned to either the modified Attachment and Biobehavioral Catch-Up (mABC) intervention or a control intervention. The study aims to enhance maternal sensitivity and nurturing behaviors, which are expected to lead to better outcomes for both mothers and their infants in terms of attachment and physiological regulation.
Who should consider this trial
Good fit: Ideal candidates for this study are opioid-dependent pregnant women in their third trimester who are receiving medication-assisted treatment.
Not a fit: Patients who are not opioid-dependent or who are not in the third trimester of pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve parenting practices and developmental outcomes for infants born to opioid-dependent mothers.
How similar studies have performed: Other studies have shown promise in using similar interventions to improve parenting and child outcomes in at-risk populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment Exclusion Criteria: * None
Where this trial is running
Newark, Delaware
- University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Mary Dozier, Ph.D. — University of Delaware
- Study coordinator: Mary Dozier, Ph.D.
- Email: mdozier@udel.edu
- Phone: 3028312286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.