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Clinical Trials/NCT06733649
NCT06733649
Not yet recruiting
Not Applicable

Treatment Education for Pre- and Postpartum Women and Their Community Support

Johns Hopkins University0 sites80 target enrollmentStarted: July 6, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Primary Endpoint
Percentage of women interested in study participation

Overview

Brief Summary

The study evaluates the feasibility and acceptability of a 50 minute treatment education session for perinatal women with opioid use disorder and a community support person. The education session provides correct information about opioid agonist medications and neonatal abstinence syndrome.

Detailed Description

Perinatal women with opioid disorder often face criticism by social network members for receiving opioid agonist treatment. Feeling stigmatized by others may impact willingness to start and remain in agonist treatment.

The present study evaluates the feasibility and acceptability of a 50 minute treatment education session for perinatal women who are treated using an agonist medication (methadone or buprenorphine) and community support chosen by the patient.

Study participants will be recruited from perinatal women who receive substance abuse treatment at the Center for Addiction and Pregnancy or Addiction Treatment Services at Johns Hopkins Bayview campus. These women will work with a counselor to select a community support person to bring to the program for the education session.

The session will provide correct information on opioid agonist medications and neonatal abstinence syndrome. This session will follow a structured outline.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • perinatal women treated with agonist medication
  • interest in study participation
  • interest in community support:
  • interest in study participation

Exclusion Criteria

  • perinatal women not treated with agonist medication
  • not interested in study participation
  • not interested in community support:
  • not interested in study participation

Arms & Interventions

Treatment education for perinatal women and the womens' community support

Experimental

Intervention: substance abuse treatment education (Other)

Outcomes

Primary Outcomes

Percentage of women interested in study participation

Time Frame: Immediately before session 1

Feasibility -- percentage of women interested in study participation

Percentage of interested women who bring in community support to the education group

Time Frame: Immediately before session 1

Acceptability -- proportion of interested women who bring in community support to the education group

Secondary Outcomes

  • Knowledge as assessed by survey(Baseline, Immediately after session 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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