Supporting Treatment for Opioids and Recovery Capital (STORC) - R61 Phase
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFriends Research Institute, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
STORC
BehavioralSTORC 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: STORCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Feasibility
Number of eligible participants recruited for the trial relative to the number screened.
Time frame
at study completion, up to 3 months2
Acceptability of the Intervention
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.
Time frame
At 3 month follow-upSecondary outcomes
1
Appropriateness of the Intervention
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.
Time frame
at 3 month follow-up2
Recovery Capital
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.
Time frame
Changes from baseline to 3 months follow-up3
Self-efficacy
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.
Time frame
Changes from baseline to 3 months4
Substance use
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.
Time frame
The past 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Friends Research Institute, Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov