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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
30
"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.
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.
Baystate Medical Center
Springfield, Massachusetts, United States
Recruitment and enrollment
The number of mothers referred, approached, and enrolled in the study
Time frame: Through study completion up to 3 months
Number of Early Intervention services received
All Early Intervention services received by mothers and their child(ren)
Time frame: Through intervention period, an average of 6 months
The duration of intervention sessions
Session duration in minutes
Time frame: Through intervention period, an average of 6 months
The number of intervention sessions completed by mothers
The total number of sessions completed
Time frame: Through intervention period, an average of 6 months
Mothers' perceived barriers and facilitators to intervention delivery
Qualitative perceptions of intervention logistics
Time frame: Through intervention period, an average of 6 months
The number of supervision sessions completed by providers
The total number of sessions completed
Time frame: 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
Time frame: Post-intervention up to 3 months
Retention of study participants
Time to loss of follow-up and perceived reason for discontinuation
Time frame: Through study completion up to 3 months
Qualitative perceptions of intervention sessions from mothers
Open-ended feedback of intervention sessions
Time frame: Through intervention period, an average of 6 months
Qualitative perceptions of intervention sessions from Early Intervention providers
Open-ended feedback of intervention sessions
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Through intervention period for each mother participant, an average of 6 months
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.
Time frame: 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.
Time frame: 0, 3, 6 months
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