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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 20, 2023

Completed
Last Updated

April 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

October 28, 2020

Results QC Date

February 26, 2023

Last Update Submit

March 28, 2023

Conditions

Keywords

fathersrelapse preventionopioid-use disorderbehavioral parent training

Outcome Measures

Primary Outcomes (3)

  • 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.

    [Baseline (pretest) & 5 weeks (posttest)] Change in parenting practices from baseline to 5 weeks.

  • 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.

    [Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeks

  • 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.

    [Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks

Study Arms (1)

FIR Prototype Evaluation

EXPERIMENTAL

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

Behavioral: Fathering In Recovery

Interventions

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.

FIR Prototype Evaluation

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Jeremy Jones
Organization
Oregon Research Behavioral Intervention Strategies, Inc. dba Behavioral Influents Innovations

Study Officials

  • Jeremy A Jones, Ph.D.

    Oregon Research Behavioral Intervention Strategies, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 2, 2020

Study Start

August 6, 2021

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

April 20, 2023

Results First Posted

April 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will become available upon completion of final analysis and publication of results.
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.

Locations