Trial Outcomes & Findings for Fathering In Recovery (NCT NCT04611542)

NCT ID: NCT04611542

Last Updated: 2023-04-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2023-04-20

Participant Flow

Participant milestones

Participant milestones
Measure
FIR Prototype Evaluation
30 fathers in recovery from opioid-use disorder will receive the prototype FIR online intervention. Fathering 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.
Overall Study
STARTED
30
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fathering In Recovery

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: [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.

Outcome measures

Outcome measures
Measure
Fathers Participating in the FIR Program
n=28 Participants
Twenty-eight fathers that participated in the FIR program and completed the pretest and posttest.
Parenting Practices Interview
Pretest
2.84 score on a scale
Standard Deviation .70
Parenting Practices Interview
Posttest
3.83 score on a scale
Standard Deviation .52

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
Fathers Participating in the FIR Program
n=28 Participants
Twenty-eight fathers that participated in the FIR program and completed the pretest and posttest.
Parenting Efficacy
Pretest
6.27 score on a scale
Standard Deviation 1.29
Parenting Efficacy
Posttest
7.39 score on a scale
Standard Deviation .91

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
Fathers Participating in the FIR Program
n=28 Participants
Twenty-eight fathers that participated in the FIR program and completed the pretest and posttest.
Program Knowledge
Pretest
2.54 score on a scale
Standard Deviation 1.43
Program Knowledge
Posttest
8.86 score on a scale
Standard Deviation .37

Adverse Events

FIR Prototype Evaluation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeremy Jones

Oregon Research Behavioral Intervention Strategies, Inc. dba Behavioral Influents Innovations

Phone: 541-484-2123

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place