Intervening With Opioid-Dependent MothersMothers and Infants

NCT ID: NCT04454645

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2026-03-31

Brief Summary

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This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.

Detailed Description

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Pregnant mothers will be randomly assigned to receive the modified ABC intervention or the control intervention (modified DEF). Hypotheses relate to parent and child outcomes associated with the intervention. Hypothesis 1: Compared to mothers who receive the control intervention, mothers who receive the mABC intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 2: Compared to infants of mothers who receive the control intervention, infants of mothers who receive the mABC intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 3: Enhanced maternal sensitivity will mediate effects of the mABC intervention on improved infant outcomes.

Conditions

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Opioid Dependence Parenting Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Modified ABC

12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.

Group Type EXPERIMENTAL

mABC

Intervention Type BEHAVIORAL

Intervention targets parenting sensitivity and nurturance.

Modified DEF

12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development

Group Type ACTIVE_COMPARATOR

mDEF

Intervention Type BEHAVIORAL

Intervention targets parenting enhancing infant cognitive development

Interventions

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mABC

Intervention targets parenting sensitivity and nurturance.

Intervention Type BEHAVIORAL

mDEF

Intervention targets parenting enhancing infant cognitive development

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Mary Dozier

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Dozier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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University of Delaware

Newark, Delaware, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary Dozier, Ph.D.

Role: CONTACT

3028312286

Other Identifiers

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1R01HD098525-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

mABC

Identifier Type: -

Identifier Source: org_study_id

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