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

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Baystate Medical Center

Status

Completed

Conditions

Opioid-use Disorder
Parenting
Substance Use Disorders

Treatments

Behavioral: pCARE
Other: Standard Early Intervention services

Study type

Interventional

Funder types

Other

Identifiers

NCT04675099
BH-20-132

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Control
Active Comparator group
Description:
Standard Early Intervention services
Treatment:
Other: Standard Early Intervention services
Intervention
Experimental group
Description:
pCARE
Treatment:
Other: Standard Early Intervention services
Behavioral: pCARE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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