- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532619
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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