- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611542
Fathering In Recovery (FIR)
Evaluation of Phase I Fathering In Recovery Prototype
Study Overview
Status
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Research Behavioral Intervention Strategies, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
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.
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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.
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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.
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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.
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[Baseline (pretest) & 5 weeks (posttest)] Change in parenting practices from baseline to 5 weeks.
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Parenting Efficacy
Time Frame: [Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeks
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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.
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[Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeks
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Program Knowledge
Time Frame: [Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks
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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.
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[Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks
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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
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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).
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[Baseline & 5 weeks] Change in self-reported substance use from baseline to 5 weeks
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Broad Psychopathology
Time Frame: [Baseline & 5 weeks] Change in ratings of psychopathology from baseline to 5 weeks
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Twenty-one items from the PhenX Toolkit measuring Broad Psychopathology.
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[Baseline & 5 weeks] Change in ratings of psychopathology from baseline to 5 weeks
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PHQ-9
Time Frame: [Baseline & 5 weeks] Change in ratings of depression severity from baseline to 5 weeks
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Nine items from the Patient Health Questionnaire assessing severity of depression.
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[Baseline & 5 weeks] Change in ratings of depression severity from baseline to 5 weeks
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Father Involvement
Time Frame: [Baseline & 5 weeks] Change in fathering involvement from baseline to 5 weeks
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The 10-item Father Research and Practitioner Network, Father Engagement Scale for resident and nonresident fathers.
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[Baseline & 5 weeks] Change in fathering involvement from baseline to 5 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeremy A Jones, Ph.D., Oregon Research Behavioral Intervention Strategies, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA052949
- R43DA052949-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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