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Fathering In Recovery (FIR)

Primary Purpose

Parenting, Opioid-use Disorder, Father-Child Relations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fathering In Recovery
Sponsored by
Oregon Research Behavioral Intervention Strategies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting focused on measuring fathers, relapse prevention, opioid-use disorder, behavioral parent training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Oregon Research Behavioral Intervention Strategies, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FIR Prototype Evaluation

Arm Description

30 fathers in recovery from opioid-use disorder will receive the prototype FIR online intervention.

Outcomes

Primary Outcome Measures

Parenting Practices Interview
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.
Parenting Efficacy
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.
Program Knowledge
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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2020
Last Updated
March 28, 2023
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04611542
Brief Title
Fathering In Recovery
Acronym
FIR
Official Title
Evaluation of Phase I Fathering In Recovery Prototype
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Opioid-use Disorder, Father-Child Relations, Fathers
Keywords
fathers, relapse prevention, opioid-use disorder, behavioral parent training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FIR Prototype Evaluation
Arm Type
Experimental
Arm Description
30 fathers in recovery from opioid-use disorder will receive the prototype FIR online intervention.
Intervention Type
Behavioral
Intervention Name(s)
Fathering In Recovery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parenting Practices Interview
Description
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.
Time Frame
[Baseline (pretest) & 5 weeks (posttest)] Change in parenting practices from baseline to 5 weeks.
Title
Parenting Efficacy
Description
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.
Time Frame
[Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeks
Title
Program Knowledge
Description
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.
Time Frame
[Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Father with at least part time custody of at least one child between the ages 3-12 In recovery from OUD English-speaking Abstinent from substances other than marijuana and alcohol for no more than 1 year 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy A Jones, Ph.D.
Organizational Affiliation
Oregon Research Behavioral Intervention Strategies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Behavioral Intervention Strategies, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Fathering In Recovery

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