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Fathering In Recovery

Evaluation of Phase I Fathering In Recovery Prototype

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04611542
Acronym
FIR
Enrollment
30
Registered
2020-11-02
Start date
2021-08-06
Completion date
2021-11-04
Last updated
2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Father-Child Relations, Fathers, Opioid-use Disorder, Parenting

Keywords

fathers, relapse prevention, opioid-use disorder, behavioral parent training

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.

Interventions

BEHAVIORALFathering In Recovery

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Oregon Research Behavioral Intervention Strategies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Parenting Practices Interview[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[Baseline (pretest) & 5 weeks (posttest)] Change in parenting efficacy from baseline to 5 weeksFour 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[Baseline (pretest) & 5 weeks (posttest)] Change in program knowledge from baseline to 5 weeksKnowledge 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Fathers
Thirty fathers were recruited, consented, and participated in the baseline assessment. Twenty-eight of those fathers engaged in the four-week Fathering in Recovery online intervention and were retained for the post-test (completed one week after program completion - week 5).
30
Total30

Baseline characteristics

CharacteristicIntervention Fathers
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
27 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
30 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

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.

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

Population: Twenty-eight fathers who participate in the FIR intervention.

ArmMeasureGroupValue (MEAN)Dispersion
Fathers Participating in the FIR ProgramParenting EfficacyPretest6.27 score on a scaleStandard Deviation 1.29
Fathers Participating in the FIR ProgramParenting EfficacyPosttest7.39 score on a scaleStandard Deviation 0.91
p-value: <0.001t-test, 2 sided
Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Fathers Participating in the FIR ProgramParenting Practices InterviewPretest2.84 score on a scaleStandard Deviation 0.7
Fathers Participating in the FIR ProgramParenting Practices InterviewPosttest3.83 score on a scaleStandard Deviation 0.52
p-value: <0.001t-test, 2 sided
Primary

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.

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

Population: Twenty-eight fathers that engaged in the intervention.

ArmMeasureGroupValue (MEAN)Dispersion
Fathers Participating in the FIR ProgramProgram KnowledgePretest2.54 score on a scaleStandard Deviation 1.43
Fathers Participating in the FIR ProgramProgram KnowledgePosttest8.86 score on a scaleStandard Deviation 0.37
p-value: <0.001t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026