Treatment Education for Perinatal Women and Their Community Support

NCT06733649 | Not Yet Recruiting

• 1 other identifier: IRB00478467
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependency

Keywords

opioid dependence; perinatal women; social support

Outcome Measures

Primary Outcomes (2)

• Percentage of women interested in study participation

  Feasibility -- percentage of women interested in study participation

  Immediately before session 1

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

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

  Immediately before session 1

Secondary Outcomes (1)

• Knowledge as assessed by survey

  Baseline, Immediately after session 1

Study Arms (1)

Treatment education for perinatal women and the womens' community support

EXPERIMENTAL

Other: substance abuse treatment education

Interventions

substance abuse treatment education OTHER

Perinatal women and the women's community support will receive a 50 minute education session that provides correct information on opioid agonist medications and neonatal abstinence syndrome.

Treatment education for perinatal women and the womens' community support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Kidorf, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Kidorf, Ph.D.

CONTACT

410 550 0006; mkidorf@jhmi.edu

Denis Antoine, MD

CONTACT

410 550 7843; antoine@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Perinatal women and the woman's community support will receive one treatment education session.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): December 5, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share