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

NCT04675099 | Completed DMC

• 1 other identifier: BH-20-132
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (13)

• Recruitment and enrollment

  The number of mothers referred, approached, and enrolled in the study

  Through study completion up to 3 months

• Number of Early Intervention services received

  All Early Intervention services received by mothers and their child(ren)

  Through intervention period, an average of 6 months

• The duration of intervention sessions

  Session duration in minutes

  Through intervention period, an average of 6 months

• The number of intervention sessions completed by mothers

  The total number of sessions completed

  Through intervention period, an average of 6 months

• Mothers' perceived barriers and facilitators to intervention delivery

  Qualitative perceptions of intervention logistics

  Through intervention period, an average of 6 months

• The number of supervision sessions completed by providers

  The total number of sessions completed

  Through intervention period for each mother participant, an average of 6 months

• Early Intervention and additional services received by mothers after intervention period

  Services received qualitatively listed by mothers

  Post-intervention up to 3 months

• Retention of study participants

  Time to loss of follow-up and perceived reason for discontinuation

  Through study completion up to 3 months

• Qualitative perceptions of intervention sessions from mothers

  Open-ended feedback of intervention sessions

  Through intervention period, an average of 6 months

• Qualitative perceptions of intervention sessions from Early Intervention providers

  Open-ended feedback of intervention sessions

  Through intervention period for each mother participant, an average of 6 months

• Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period

  Open-ended feedback via a 30-minute interview

  Post-intervention for each mother participant up to 3 months

• Qualitative perceptions of intervention sessions from mothers after intervention period

  Open-ended feedback via a 30-minute interview

  3 months after the completion of the intervention

• Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale

  The revised Mothering from the Inside Out (MIO) Adherence Rating Scale is a 9-item measure rated on a 3-point scale for frequency of occurrence (never or seldom, sporadically, or consistent) and competence (poorly executed, adequately executed, or well-executed) of intervention delivery. The measure uses intervention session audio- or video- recordings and includes MIO specific fidelity and a measure of therapeutic alliance.

  Through intervention period for each mother participant, an average of 6 months

Secondary Outcomes (2)

• Changes in parental reflective functioning according to the Parent Development Interview (PDI)

  0, 3, and 6 months

• Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual

  0, 3, 6 months

Other Outcomes (5)

• Changes in psychiatric symptoms according to the Brief Symptom Index (BSI)

  0, 1, 2, 3, and 6 months

• Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9)

  0, 1, 2, 3, and 6 months

• Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ)

  0, 1, 2, 3, and 6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard Early Intervention services

Other: Standard Early Intervention services

Intervention

EXPERIMENTAL

pCARE

Behavioral: pCARE; Other: Standard Early Intervention services

Interventions

pCARE 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.

Also known as: Mothering from the Inside Out

Intervention

Standard Early Intervention services 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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01109, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elizabeth Peacock-Chambers, MD, MSc

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 19, 2020
• Study Start: December 18, 2020
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)