Treatment Education for Perinatal Women and Their Community Support

Not Applicable

Not yet recruiting

• Conditions: Opioid Dependency

• Registration Number: NCT06733649
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Study Start: 2025-06-06
• Primary Completion: 2026-01-05
• Study Completion: 2026-07-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of women interested in study participation	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	Immediately before session 1	Acceptability -- proportion of interested women who bring in community support to the education group

Secondary Outcome Measures

Name	Time	Method
Knowledge as assessed by survey	Baseline, Immediately after session 1	Women and the womens' community support will complete a 10 question true / false test before and after the education session