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pCARE Parenting Intervention for Substance Use Disorder (pCARE Trial)
N/A
Waitlist Available
Led By Elizabeth Peacock-Chambers, MD, MSc
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1, 2, 3, and 6 months
Awards & highlights
pCARE Trial Summary
This trial will study whether a parenting intervention developed for postpartum women with substance use disorder is feasible and acceptable, and if it has preliminary positive outcomes.
Who is the study for?
This trial is for English-speaking mothers over 18 with a child aged 0-2 years, who are receiving parenting support and have been in formal recovery from substance use disorders for at least 3 months. They must live within the area served by participating programs. Mothers with significant cognitive impairments, children with severe interaction-limiting conditions, or severe mental health issues are excluded.Check my eligibility
What is being tested?
The study tests an intervention called pCARE designed to help postpartum women with substance use disorder using Early Intervention services. It's a pilot randomized controlled trial assessing feasibility, acceptability, and preliminary outcomes of integrating Mothering from the Inside Out into these services.See study design
What are the potential side effects?
As this is a behavioral intervention focusing on caregiver-child attachment rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience emotional discomfort or stress related to discussing personal experiences during therapy sessions.
pCARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been part of a recovery support program for at least 3 months.
pCARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 1, 2, 3, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1, 2, 3, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale
Early Intervention and additional services received by mothers after intervention period
Mothers' perceived barriers and facilitators to intervention delivery
+10 moreSecondary outcome measures
Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual
Changes in parental reflective functioning according to the Parent Development Interview (PDI)
Other outcome measures
Depressive Symptoms
Changes in parenting stress according to the Parenting Stress Index (PSI)
Changes in psychiatric symptoms according to the Brief Symptom Index (BSI)
+2 morepCARE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
pCARE
Group II: ControlActive Control1 Intervention
Standard Early Intervention services
Find a Location
Who is running the clinical trial?
Baystate Medical CenterLead Sponsor
63 Previous Clinical Trials
44,243 Total Patients Enrolled
Elizabeth Peacock-Chambers, MD, MScPrincipal Investigator - Baystate Medical Center
Baystate Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am the mother of a child who is currently under 2 years old.I am 18 years old or older.I am open to getting parenting help for my child through EI.I speak English.My child has a serious health condition that affects our interaction.I am able to understand and make decisions about my health care.I have been part of a recovery support program for at least 3 months.You have had serious mental health issues in the past year, such as feeling suicidal, having thoughts of hurting others, or experiencing episodes of psychosis.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this experiment?
"Affirmative, clinicaltrials.gov confirms that this medical trial is recruiting participants. It was first listed on December 18th 2020 and updated most recently in February 2022. 40 volunteers are needed for the study at a single site of enrollment."
Answered by AI
Are there any vacancies in this clinical trial open to participants?
"Clinicaltrials.gov confirms that this medical experiment, dated from December 18th of 2020, is still searching for participants. The last update was done on February 28th 2022."
Answered by AI
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