Clinical trial NCT04675099: Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
Official title: Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Substance Use Disorders
Parenting
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Recruitment and enrollment
timeFrame: Through study completion up to 3 months
measure: Number of Early Intervention services received
timeFrame: Through intervention period, an average of 6 months
measure: The duration of intervention sessions
timeFrame: Through intervention period, an average of 6 months
measure: The number of intervention sessions completed by mothers
timeFrame: Through intervention period, an average of 6 months
measure: Mothers' perceived barriers and facilitators to intervention delivery
timeFrame: Through intervention period, an average of 6 months
measure: The number of supervision sessions completed by providers
timeFrame: Through intervention period for each mother participant, an average of 6 months
measure: Early Intervention and additional services received by mothers after intervention period
timeFrame: Post-intervention up to 3 months
measure: Retention of study participants
timeFrame: Through study completion up to 3 months
measure: Qualitative perceptions of intervention sessions from mothers
timeFrame: Through intervention period, an average of 6 months
measure: Qualitative perceptions of intervention sessions from Early Intervention providers
timeFrame: Through intervention period for each mother participant, an average of 6 months
measure: Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period
timeFrame: Post-intervention for each mother participant up to 3 months
measure: Qualitative perceptions of intervention sessions from mothers after intervention period
timeFrame: 3 months after the completion of the intervention
measure: Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale
timeFrame: Through intervention period for each mother participant, an average of 6 months
Secondary outcomes:
measure: Changes in parental reflective functioning according to the Parent Development Interview (PDI)
timeFrame: 0, 3, and 6 months
measure: Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual
timeFrame: 0, 3, 6 months
Other outcomes:
measure: Changes in psychiatric symptoms according to the Brief Symptom Index (BSI)
timeFrame: 0, 1, 2, 3, and 6 months
measure: Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 0, 1, 2, 3, and 6 months
measure: Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ)
timeFrame: 0, 1, 2, 3, and 6 months
measure: Changes in parenting stress according to the Parenting Stress Index (PSI)
timeFrame: 0, 1, 2, 3, and 6 months
measure: Child development using the Batelle Developmental Inventory
timeFrame: At baseline
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Elizabeth Peacock-Chambers, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: