Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04611542 |
| Other study ID # |
DA052949 |
| Secondary ID |
R43DA052949-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 6, 2021 |
| Est. completion date |
November 4, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
Oregon Research Behavioral Intervention Strategies, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The majority of men experiencing opioid use disorder and receiving treatment are fathers.
Substance use, transitions between in-patient and out-patient treatment, and reunification as
a family, all create considerable strain and are predictive of a host of negative long-term
outcomes including increased rates of relapse for fathers and elevated risk for behavioral,
emotional, and substance use problems in their children. Evidence-based parenting
interventions for fathers are lacking in general, yet are exceedingly rare for fathers
participating in opioid use disorder treatment, even though the extant research literature
suggests the integration of services is not only timely but may help engage and retain
fathers in treatment and produce protective factors for children. The goal of this project is
to develop and evaluate a prototype of a usable innovative web-based program that integrates
existing evidence-based parenting programs, yet tailored specifically to fathers with opioid
use disorder and designed for the opioid treatment context in order to promote the
implementation and dissemination of father specific empirically-supported treatment.
Description:
Investigators will recruit participants for this project through substance use treatment
centers in Oregon. Recruitment for the 30 fathers for the evaluation testing will be
coordinated in collaboration with substance use treatment center staff members who will
contact potentially eligible fathers to give a brief description of the project and ask for
permission for Oregon Research Behavioral Intervention Strategies (ORBIS) staff to contact
them to provide further information about the study. Fathers that do not give permission for
treatment center staff will not be contacted by ORBIS, though they can contact ORBIS directly
using the contact information in a brochure that they will receive from treatment centers.
Once treatment center staff receive permission from a father for ORBIS to contact them,
project staff will call to further explain the details of the project, confirm eligibility
requirements and discuss confidentiality. If the father expresses interest in participating,
we will send him an information packet and schedule an interview (or a visit if we feel that
is necessary to ensure that he understands the project and what we are asking of him).
A total of 30 individual fathers that are eligible and consent to participate will be
enrolled in the study. Over a 5-week period (1 week for pretest assessments, 3 weeks for
training and skills practice, 1 week for posttest assessments) fathers will participate in
using the Fathering In Recovery (FIR) program. To address promise of efficacy, the primary
approach for the evaluation of the phase I prototype will be by assessing improvements on
pre-intervention to post-intervention outcomes including, parenting knowledge, parenting
efficacy, parenting skill, and pre-post reductions in substance use. Fathers will receive a
total of $200 for participation in the study.
