ParentingFIRNCT04611542
Fathering In Recovery
A study testing Fathering In Recovery in people with Parenting and Opioid-use Disorder, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Parenting, Opioid-use Disorder, Father-Child Relations
- What is being tested?
- Fathering In Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to 4 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Eugene, Oregon, 97401
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting, Opioid-use Disorder, Father-Child Relations, Fathers
- Being tested
- Fathering In Recovery
- Keywords
- fathers, relapse prevention, opioid-use disorder, behavioral parent training
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fathering In RecoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FIR Prototype Evaluation | Experimental | 30 fathers in recovery from opioid-use disorder will receive the prototype FIR online intervention. Receives: Behavioral: Fathering In Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [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.
Measured: [Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start6 Aug 2021
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jeremy A Jones, Ph.D., Principal investigator, Oregon Research Behavioral Intervention Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611542
- Sponsor's protocol ID
- DA052949
- Other IDs
- R43DA052949-01
- Acronym
- FIR
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2020
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD that underlie results in a publication will be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Phase I Fathering In Recovery Prototype
- ClinicalTrials.gov ID
- NCT04611542
- Acronym / sponsor ID
- FIR / DA052949
- Conditions
- Parenting, Opioid-use Disorder, Father-Child Relations, Fathers
- Keywords
- fathers, relapse prevention, opioid-use disorder, behavioral parent training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIR Prototype Evaluation | Experimental | Behavioral: Fathering In Recovery30 fathers in recovery from opioid-use disorder will receive the prototype FIR online intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fathering In RecoveryFathering 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. | Behavioural | FIR Prototype Evaluation |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All de-identified IPD that underlie results in a publication will be shared with other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy A Jones, Ph.D. principal investigator
Oregon Research Behavioral Intervention Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fathering In Recovery in people with Parenting and Opioid-use Disorder, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Practices Interview (time frame: [Baseline (pretest) & 5 weeks (posttest)] Change in parenting practices from baseline to 5 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.