Supporting Treatment for Opioids and Recovery Capital (STORC) - R61 Phase (STORC R61)

August 21, 2026 updated by: Friends Research Institute, Inc.

Empowering Support Persons to Enhance the Recovery Capital of Postpartum Women With Opioid Use Disorder - R61 Phase

We are studying whether training an identified support person and providing patient navigation (i.e. a peer recovery specialist assisting you with finding the right support) after delivery can increase "recovery capital"-the resources that help people with opioid use disorder (OUD) stay in treatment and recover. This study will build upon the research team's prior work in conducting research among pregnant and parenting women with OUD. This project will be directed by the research team at Friends Research Institute in close collaboration with their research and clinical partners at the University of Pennsylvania in Philadelphia, PA. A two-phase study is proposed with an initial 1-year developmental phase (R61) that will develop and pilot test STORC to include support person training. A second 4-year phase (R33) will test STORC in a parallel, two-arm, randomized controlled trial design at two study sites.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The developmental R61 phase will focus on developing training materials and pilot testing STORC for feasibility and acceptability. This will be accomplished through three interrelated processes: 1) Developing materials to train support persons, including creating digital education content with expert consultants; 2) Pilot testing STORC recruitment procedures and training content to evaluate feasibility and acceptability; 3) Conducting qualitative interviews to gain diverse stakeholder input at the end of the pilot trial; and 4) Refining training materials into a final digital product with our media consultant.

Aim 1 (Months 2-12): We will develop and refine training materials to create a robust support person training. We will do this through an iterative process that first uses feedback from expert consultants with lived experience (two of whom are certified recovery specialists working in the PROUD clinic). These experts will develop scripts to communicate the training content to support persons, and we will work with our media production partner to produce the video content. After the pilot trial in Aim 2, we will refine the content and update any training portions that need improvement after qualitative interviews.

Aim 2: (Months 4-10) Pilot test STORC for feasibility and acceptability (N = 20 [10 patient/support person dyads]) and refine with feedback from the dyads at completion of the pilot. All participants will also view the training videos and provide feedback. The qualitative feedback and results of the pilot testing will inform the final STORC protocol used in the R33 phase.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • must be biological females
  • must be currently within 6 weeks postpartum
  • must be able to read, write, and speak English at a 6th-grade level
  • must be diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder at the PROUD clinic
  • must identify a support person who also consents to participate. Patient participants must identify prospective support persons in order to complete consent

Exclusion Criteria:

  • pregnancy
  • planned discharge to a long-term inpatient care facility (e.g., hospice)
  • hospitalization for a suicide attempt
  • major mental health disorder that requires treatment before OAT can be considered
  • stillbirth or neonatal death of the index pregnancy/infant, as determined from the obstetric record.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STORC
STORC is inclusive of patient navigation and support person training.
Behavioral: STORC
STORC will operate as a service model integrating both designated support persons and specialized patient navigators to enhance recovery capital and improve secondary outcomes, including increased OAT retention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Feasibility
Time Frame: at study completion, up to 3 months
Number of eligible participants recruited for the trial relative to the number screened.
at study completion, up to 3 months
Acceptability of the Intervention
Time Frame: At 3 month follow-up
Intervention acceptability will be measured using the 4-item Acceptability of Intervention Measure (AIM), a valid and reliable self-report measure of the extent to which participant accepts the intervention as relevant to their experience. The AIM is scored from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.
At 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness of the Intervention
Time Frame: at 3 month follow-up
Intervention appropriateness will be measured using the 4-item Intervention Appropriateness Measure (IAM), a valid and reliable self-report measure of the extent to which participants see the intervention as appropriate for who they are and their experience. The IAM is scored from 1 to 5, with higher scores indicating greater perceived appropriateness of the intervention.
at 3 month follow-up
Recovery Capital
Time Frame: Changes from baseline to 3 months follow-up
Recovery Capital will be assessed using the Brief Assessment of Recovery Capital-10 (BARC-10). The BARC-10 is scored from 10 to 60, with higher scores indicating greater recovery capital.
Changes from baseline to 3 months follow-up
Self-efficacy
Time Frame: Changes from baseline to 3 months
The degree to which a person is confident they can make a change in health related behavior measured using the Patient Activation Measured (PAM). The PAM-10 is scored from 0 to 100, with higher scores indicating greater patient activation, reflecting greater knowledge, skills, and confidence in managing one's health and healthcare.
Changes from baseline to 3 months
Substance use
Time Frame: The past 30 days
Timeline follow-up of substance use in the past 30 days measured by number of days of substance use during the past 30 days, assessed at each follow-up visit.
The past 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Karen Alexander, Friends Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 26, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R61DA064704 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be published after study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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