Fathering In Recovery (FIR)

Evaluation of Phase I Fathering In Recovery Prototype

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Research Behavioral Intervention Strategies, Inc.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion:

  1. Father with at least part time custody of at least one child between the ages 3-12
  2. In recovery from OUD
  3. English-speaking
  4. Abstinent from substances other than marijuana and alcohol for no more than 1 year
  5. Has access to technology allowing for watching internet-based videos such as a smart phone or similar device. Participants will be screened for eligibility criteria by Influents Innovations staff.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIR Prototype Evaluation
30 fathers in recovery from opioid-use disorder will receive the prototype FIR online intervention.
Fathering In Recovery (FIR) will be designed to address the unique needs of fathers in treatment for opioid misuse. FIR integrates evidence-based parenting interventions that have well-documented positive outcomes on children, parents, and families, with innovative web-based mobile technology to maximize accessibility, fidelity, and consistency of intervention and support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Practices Interview
Time Frame: [Baseline (pretest) & 5 weeks (posttest)] Change in parenting practices from baseline to 5 weeks.
Three sub-scales from the Parenting Practices Interview (PPI): harsh discipline (11 items), inept discipline (9 items), and pro-social parenting. The items are coded on a 7-point scale (1-7) with higher meaning better outcomes. Subscales are averaged to compute a total score.
[Baseline (pretest) & 5 weeks (posttest)] Change in parenting practices from baseline to 5 weeks.
Parenting Efficacy
Time Frame: [Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeks
Four 6-item subscales from the Tool for measuring Parent Self-Efficacy (TOPSE): measuring domains of play and enjoyment, discipline practices, perceived control in parenting, and acceptance of parenting role. The items are coded on an 11-point scale (0-10) with higher meaning better outcomes. Subscales are averaged to compute a total score.
[Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeks
Program Knowledge
Time Frame: [Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks
Knowledge will be assessed to determine the extent to which participants understand basic knowledge delivered in the program. Knowledge items will be derived from conceptual and practical content lessons. 18 items derived from the content on emotion regulation, good directions, and encouragement, will be assessed using multiple-choice questions on a questionnaire developed by the researchers. The items are coded on an 11-point scale (0-10) with higher meaning better outcomes. Subscales are averaged to compute a total score.
[Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance Use
Time Frame: [Baseline & 5 weeks] Change in self-reported substance use from baseline to 5 weeks
Substance use frequency in the last 30 days will be assessed with the PhenX Toolkit measure adapted from the National Survey on Drug Use and Health (NSDUH).
[Baseline & 5 weeks] Change in self-reported substance use from baseline to 5 weeks
Broad Psychopathology
Time Frame: [Baseline & 5 weeks] Change in ratings of psychopathology from baseline to 5 weeks
Twenty-one items from the PhenX Toolkit measuring Broad Psychopathology.
[Baseline & 5 weeks] Change in ratings of psychopathology from baseline to 5 weeks
PHQ-9
Time Frame: [Baseline & 5 weeks] Change in ratings of depression severity from baseline to 5 weeks
Nine items from the Patient Health Questionnaire assessing severity of depression.
[Baseline & 5 weeks] Change in ratings of depression severity from baseline to 5 weeks
Father Involvement
Time Frame: [Baseline & 5 weeks] Change in fathering involvement from baseline to 5 weeks
The 10-item Father Research and Practitioner Network, Father Engagement Scale for resident and nonresident fathers.
[Baseline & 5 weeks] Change in fathering involvement from baseline to 5 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jeremy A Jones, Ph.D., Oregon Research Behavioral Intervention Strategies, 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 (Actual)

August 6, 2021

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified IPD that underlie results in a publication will be shared with other researchers upon request.

IPD Sharing Time Frame

The data will become available upon completion of final analysis and publication of results.

IPD Sharing Access Criteria

Correspondence via email with the lead author of the publication will be necessary to access to de-identified IPD that underlie results in a publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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