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OpenTrials
Completed

NCT Number: NCT04611542

Fathering In Recovery

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.

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Key information

Conditions

Parenting Chemically-Induced Disorders Father-Child Relations Fathers Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Behavioral Intervention Strategies, Inc.

Eugene, Oregon, 97401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fathering In Recovery

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Evaluation of Phase I Fathering In Recovery Prototype

Acronym: FIR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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