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

Primary Purpose

Opioid-use Disorder, Substance Use Disorders, Parenting

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pCARE
Standard Early Intervention services
Sponsored by
Baystate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Standard Early Intervention services

pCARE

Outcomes

Primary Outcome Measures

Recruitment and enrollment
The number of mothers referred, approached, and enrolled in the study
Number of Early Intervention services received
All Early Intervention services received by mothers and their child(ren)
The duration of intervention sessions
Session duration in minutes
The number of intervention sessions completed by mothers
The total number of sessions completed
Mothers' perceived barriers and facilitators to intervention delivery
Qualitative perceptions of intervention logistics
The number of supervision sessions completed by providers
The total number of sessions completed
Early Intervention and additional services received by mothers after intervention period
Services received qualitatively listed by mothers
Retention of study participants
Time to loss of follow-up and perceived reason for discontinuation
Qualitative perceptions of intervention sessions from mothers
Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from Early Intervention providers
Open-ended feedback of intervention sessions
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period
Open-ended feedback via a 30-minute interview
Qualitative perceptions of intervention sessions from mothers after intervention period
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
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 18, 2020
Last Updated
May 2, 2023
Sponsor
Baystate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04675099
Brief Title
Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
Acronym
pCARE
Official Title
Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baystate Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Substance Use Disorders, Parenting

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard Early Intervention services
Arm Title
Intervention
Arm Type
Experimental
Arm Description
pCARE
Intervention Type
Behavioral
Intervention Name(s)
pCARE
Other Intervention Name(s)
Mothering from the Inside Out
Intervention Description
"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.
Intervention Type
Other
Intervention Name(s)
Standard Early Intervention services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment and enrollment
Description
The number of mothers referred, approached, and enrolled in the study
Time Frame
Through study completion up to 3 months
Title
Number of Early Intervention services received
Description
All Early Intervention services received by mothers and their child(ren)
Time Frame
Through intervention period, an average of 6 months
Title
The duration of intervention sessions
Description
Session duration in minutes
Time Frame
Through intervention period, an average of 6 months
Title
The number of intervention sessions completed by mothers
Description
The total number of sessions completed
Time Frame
Through intervention period, an average of 6 months
Title
Mothers' perceived barriers and facilitators to intervention delivery
Description
Qualitative perceptions of intervention logistics
Time Frame
Through intervention period, an average of 6 months
Title
The number of supervision sessions completed by providers
Description
The total number of sessions completed
Time Frame
Through intervention period for each mother participant, an average of 6 months
Title
Early Intervention and additional services received by mothers after intervention period
Description
Services received qualitatively listed by mothers
Time Frame
Post-intervention up to 3 months
Title
Retention of study participants
Description
Time to loss of follow-up and perceived reason for discontinuation
Time Frame
Through study completion up to 3 months
Title
Qualitative perceptions of intervention sessions from mothers
Description
Open-ended feedback of intervention sessions
Time Frame
Through intervention period, an average of 6 months
Title
Qualitative perceptions of intervention sessions from Early Intervention providers
Description
Open-ended feedback of intervention sessions
Time Frame
Through intervention period for each mother participant, an average of 6 months
Title
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period
Description
Open-ended feedback via a 30-minute interview
Time Frame
Post-intervention for each mother participant up to 3 months
Title
Qualitative perceptions of intervention sessions from mothers after intervention period
Description
Open-ended feedback via a 30-minute interview
Time Frame
3 months after the completion of the intervention
Title
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale
Description
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
Secondary Outcome Measure Information:
Title
Changes in parental reflective functioning according to the Parent Development Interview (PDI)
Description
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
Title
Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual
Description
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
Other Pre-specified Outcome Measures:
Title
Changes in psychiatric symptoms according to the Brief Symptom Index (BSI)
Description
The Brief Symptom Index (BSI) is a 53-item measure of psychiatric symptoms scored on a 5-point Likert scale (Cronbach's alpha = .97).
Time Frame
0, 1, 2, 3, and 6 months
Title
Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
0, 1, 2, 3, and 6 months
Title
Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ)
Description
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.
Time Frame
0, 1, 2, 3, and 6 months
Title
Changes in parenting stress according to the Parenting Stress Index (PSI)
Description
The Parenting Stress Index - Short Form (PSI) is a validated instrument assessing parenting stress (Cronbach's alpha = 0.93, test-retest coefficient = .96).
Time Frame
0, 1, 2, 3, and 6 months
Title
Child development using the Batelle Developmental Inventory
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Peacock-Chambers, MD, MSc
Organizational Affiliation
Baystate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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