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

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.

Study Overview

• Status: Completed
• Conditions: Parenting; Substance Use Disorders; Opioid-use Disorder
• Intervention / Treatment: Other: Standard Early Intervention services; Behavioral: pCARE

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01109
      • Baystate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard Early Intervention services	Other: 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.
Experimental: Intervention; pCARE	Other: 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.; Behavioral: 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.; Other Names: Mothering from the Inside Out

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parental reflective functioning according to the Parent Development Interview (PDI)	The Parent Development Interview (PDI) is a 14-item measure of parental reflective functioning in an interview format. Audio-recorded interviews are transcribed and coded on a 9-point Likert scale.	0, 3, and 6 months
Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual	Conducting a Free Play Session (a 10 minute video-recorded and coded interaction, face-to-face interaction (infants) or play session) and analyzing using 5-point Likert scale and the Coding Interactive Behavior (CIB) manual, a global coding system with 43 items (22 parent, 16 infant, and 5 dyadic codes). There are six composite scales for: maternal sensitivity, maternal intrusiveness, child involvement, child negative emotionality, dyadic reciprocity and dyadic negative states; and two additional constructs for 12-36 month olds: maternal limit setting and child compliance.	0, 3, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in psychiatric symptoms according to the Brief Symptom Index (BSI)	The Brief Symptom Index (BSI) is a 53-item measure of psychiatric symptoms scored on a 5-point Likert scale (Cronbach's alpha = .97).	0, 1, 2, 3, and 6 months
Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) is a widely used 9-item questionnaire rated on a 4-point scale with good psychometric properties including high internal consistency and construct validity.	0, 1, 2, 3, and 6 months
Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ)	The Addiction and Child Welfare Questionnaire (ACWQ) assesses past substance use and involvement with child welfare systems with yes or no questions as well as frequency on a 4- or 5- point scale.	0, 1, 2, 3, and 6 months
Changes in parenting stress according to the Parenting Stress Index (PSI)	The Parenting Stress Index - Short Form (PSI) is a validated instrument assessing parenting stress (Cronbach's alpha = 0.93, test-retest coefficient = .96).	0, 1, 2, 3, and 6 months
Child development using the Batelle Developmental Inventory	Batelle Developmental Inventory contains data collected as part of Early Intervention assessments per the Early Intervention evaluation schedule. All assessments collected during the enrollment period.	At baseline

Collaborators and Investigators

• Sponsor: Baystate Medical Center
• Investigators: Principal Investigator: Elizabeth Peacock-Chambers, MD, MSc, Baystate Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: BH-20-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No