Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial

NCT ID: NCT04675099

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2024-07-31

Brief Summary

This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.

Conditions

Opioid-use Disorder; Substance Use Disorders; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Standard Early Intervention services

Group Type: ACTIVE_COMPARATOR

Standard Early Intervention services

Intervention Type: OTHER

The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.

Intervention

pCARE

Group Type: EXPERIMENTAL

pCARE

Intervention Type: BEHAVIORAL

"Mothering from the Inside Out" is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships.

Standard Early Intervention services

Intervention Type: OTHER

The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.

Interventions

pCARE

"Mothering from the Inside Out" is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships.

Intervention Type: BEHAVIORAL

Standard Early Intervention services

The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.

Intervention Type: OTHER

Other Intervention Names

Mothering from the Inside Out

Eligibility Criteria

Inclusion Criteria

• English speaking
• 18 years of age or older
• Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery
• Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months
• Willing to receive parenting supports for the index child through EI
• Geographically based within the catchment area of participating EI programs

Exclusion Criteria

• Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year)
• Significant cognitive impairment (unable to give informed consent)
• Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baystate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Peacock-Chambers, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Peacock-Chambers, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Locations

Baystate Medical Center

Springfield, Massachusetts, United States

Countries

United States

Other Identifiers

BH-20-132

Identifier Type: -

Identifier Source: org_study_id