Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
- Conditions
- ParentingSubstance Use DisordersOpioid-use Disorder
- Interventions
- Other: Standard Early Intervention servicesBehavioral: pCARE
- Registration Number
- NCT04675099
- Lead Sponsor
- Baystate Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Standard Early Intervention services Standard Early Intervention services Intervention Standard Early Intervention services pCARE Intervention pCARE pCARE
- Primary Outcome Measures
Name Time Method The number of intervention sessions completed by mothers Through intervention period, an average of 6 months The total number of sessions completed
Early Intervention and additional services received by mothers after intervention period Post-intervention up to 3 months Services received qualitatively listed by mothers
Qualitative perceptions of intervention sessions from mothers Through intervention period, an average of 6 months Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from mothers after intervention period 3 months after the completion of the intervention Open-ended feedback via a 30-minute interview
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale Through intervention period for each mother participant, an average of 6 months 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.
Recruitment and enrollment Through study completion up to 3 months The number of mothers referred, approached, and enrolled in the study
The number of supervision sessions completed by providers Through intervention period for each mother participant, an average of 6 months The total number of sessions completed
Number of Early Intervention services received Through intervention period, an average of 6 months All Early Intervention services received by mothers and their child(ren)
Retention of study participants Through study completion up to 3 months Time to loss of follow-up and perceived reason for discontinuation
Qualitative perceptions of intervention sessions from Early Intervention providers Through intervention period for each mother participant, an average of 6 months Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period Post-intervention for each mother participant up to 3 months Open-ended feedback via a 30-minute interview
The duration of intervention sessions Through intervention period, an average of 6 months Session duration in minutes
Mothers' perceived barriers and facilitators to intervention delivery Through intervention period, an average of 6 months Qualitative perceptions of intervention logistics
- Secondary Outcome Measures
Name Time Method Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual 0, 3, 6 months 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.
Changes in parental reflective functioning according to the Parent Development Interview (PDI) 0, 3, and 6 months 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.
Trial Locations
- Locations (1)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States