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

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid-use Disorder, Substance Use Disorders, Parenting

Intervention / Treatment
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* Behavioral: pCARE
* Other: Standard Early Intervention services


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard Early Intervention services | Other: Standard Early Intervention services<br>* 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.<br>|
| Experimental: Intervention<br>pCARE | Behavioral: pCARE<br>* 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.<br>* Other names: Mothering from the Inside Out;Other: Standard Early Intervention services<br>* 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.<br>|

What is the study measuring?
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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 |