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Not yet recruiting NCT06733649

Treatment Education for Perinatal Women and Their Community Support

No phase Interventional Opioid Dependency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: substance abuse treatment education.
Who it may be relevant to
Registry conditions: Opioid Dependency. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other substance abuse treatment education
    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.

Primary outcome measures

  • Percentage of women interested in study participation [Time frame: Immediately before session 1]
  • Percentage of interested women who bring in community support to the education group [Time frame: Immediately before session 1]
Secondary outcome measures (1)
  • Knowledge as assessed by survey [Time frame: Baseline, Immediately after session 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06733649 · IRB00478467

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗