A Substance Use Adaptation of Fathering Through Change (FTC-SUD)

August 23, 2024 updated by: University of Oregon

A Pilot Study of the Fathering Through Change Intervention for Fathers With Substance Use Disorders

This study is a randomized control trial of the Fathering Through Change intervention, delivered via text messaging, to fathers in recovery for substance use disorders.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Eugene, Oregon, United States, 97402
        • Willamette Family Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • identify as being in recovery
  • abstinent from illicit substances for at least 1 day and less than one year at time of enrollment
  • parenting responsibilities for a child between the ages of 3-16
  • spend at least 2 hours per week with child between ages of 3-16
  • English speaking

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
6 weeks of Fathering Through Change videos and 3 individual coaching calls.
Fathering Through Change is an adaptation of Parent Management Training Oregon. This pilot provides a limited version of Fathering Through Change via text messaged and emailed weekly video content and includes individual coaching calls.
No Intervention: Control
Links to parenting websites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy
Time Frame: baseline to 6 weeks and baseline to 4 months
The Tool to Measure Parenting Self-Efficacy (TOPSE) consists of 48 self-efficacy statements. There are six self-efficacy statements for each domain and parents indicate how much they agree with each statement by responding to a Likert scale from 0-10 where 0 equates to completely disagree and 10 equates to completely agree. We administered the play, acceptance, and control domains. The overall score (0-10) was computed as the mean of these three sub-scale means. A higher overall score indicates greater self-efficacy.
baseline to 6 weeks and baseline to 4 months
PPI Harsh: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Harsh Parenting Subscale
Time Frame: baseline to 6 weeks and baseline to 4 months
The Parenting Practices Interview is a standardized instrument to measure parenting skills. The harsh parenting sub-scale is computed as the average (1-7) of 6 items. Lower scores are more desirable.
baseline to 6 weeks and baseline to 4 months
PPI Inept: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Inept Parenting Subscale
Time Frame: baseline to 6 weeks and baseline to 4 months
Parenting Practices Interview is a standardized instrument to measure parenting skills. The inept parenting sub-scale is computed as the average (1-7) of 11 items. Lower scores are more desirable.
baseline to 6 weeks and baseline to 4 months
PPI Prosocial: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Prosocial Parenting Subscale
Time Frame: baseline to 6 weeks and baseline to 4 months
Parenting Practices Interview is a standardized instrument to measure parenting skills. The prosocial parenting subscale is computed as the mean of 15 items on all rated on a 1-7 scale. Higher scores are more desirable.
baseline to 6 weeks and baseline to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days
Time Frame: baseline to 6 weeks and baseline to 4 months
Substance use is collected using the Center on Parenting and Opioids substance use questionnaire. We measured substance use as a dichotomous variable: any use of alcohol, cannabis, and illicit substances in the past thirty days.
baseline to 6 weeks and baseline to 4 months
Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30
Time Frame: baseline to 6 weeks and baseline to 4 months
Substance use is collected using the Center on Parenting and Opioids substance use questionnaire. We measured substance use count variable: number of days using of alcohol, cannabis, and illicit substances in the past thirty days.
baseline to 6 weeks and baseline to 4 months
SDQ: Group Mean Change at 4 Months on Child Behavior
Time Frame: baseline to 4 months
Child behavior as measured by the Strengths and Difficulties Questionnaire overall score. This scale includes twenty-five items rated on a 3-point scale ranging from 0 to 2. There are five subscales each composed of 5 items: emotional regulation, conduct, hyperactivity, peer problems, and prosocial behavior. The prosocial scale was not used for analyses and the twenty items remaining were summed into an overall score (0-40). Higher scores are more desirable.
baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Camille C Cioffi, PhD, University of Oregon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 12132019.029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with the Center on Parenting and Opioids in a repository. The data repository will initially be available only to Center on Parenting and Opioids investigators and will later become accessible for other researchers.

IPD Sharing Time Frame

The Center on Parenting and Opioids will determine the data's availability.

IPD Sharing Access Criteria

Initially only to Center on Parenting and Opioids researchers. Future public access will be determined by the Center on Parenting and Opioids (PI: Leve)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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