Back to resultsA Substance Use Adaptation of Fathering Through Change (FTC-SUD)
Primary Purpose
Parenting, Substance Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fathering Through Change
Sponsored by
About this trial
This is an interventional prevention trial for Parenting
Eligibility Criteria
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:
-
Sites / Locations
- Willamette Family Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
6 weeks of Fathering Through Change videos and 3 individual coaching calls.
Links to parenting websites
Outcomes
Primary Outcome Measures
Group mean change at 6 weeks and 4 months on parenting self-efficacy on the Tool of Parenting Self-Efficacy
TOPSE consists of 48 self-efficacy statements that address six domains of parenting; emotion and affection, play and enjoyment, empathy and understanding, control, discipline and boundary setting, pressures of parenting, self-acceptance, and learning and knowledge. 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. A higher overall score indicates greater self-efficacy.
Group mean change at 6 weeks and 4 months on parenting skills on the Parenting Practices Interview
Parenting Practices Interview is a standardized instrument to measure parenting skills. It includes three subscales: harsh discipline, inept discipline, and positive parenting. It includes 35 items on all rated on a 7-point scale. Higher scores in each subscale indicate greater frequency of the behavior.
Secondary Outcome Measures
Group mean change at 6 weeks and 4 months on substance use
Substance use is collected using the Center on Parenting and Opioids substance use questionnaire. We will measure substance use as a both a dichotomous variable (using or not using) and as frequency of use of alcohol, cannabis, and illicit substances in the past thirty days.
Group mean change at 4 months on child behavior
Child behavior as measured by the Strengths and Difficulties Questionnaire prosocial behavior scale. This scale includes five items, rated on a 3-point scale ranging from 0 to 2. Higher scores indicate greater prosocial behavior.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04532619
Brief Title
A Substance Use Adaptation of Fathering Through Change
Acronym
FTC-SUD
Official Title
A Pilot Study of the Fathering Through Change Intervention for Fathers With Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Substance Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
6 weeks of Fathering Through Change videos and 3 individual coaching calls.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Links to parenting websites
Intervention Type
Behavioral
Intervention Name(s)
Fathering Through Change
Intervention Description
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.
Primary Outcome Measure Information:
Title
Group mean change at 6 weeks and 4 months on parenting self-efficacy on the Tool of Parenting Self-Efficacy
Description
TOPSE consists of 48 self-efficacy statements that address six domains of parenting; emotion and affection, play and enjoyment, empathy and understanding, control, discipline and boundary setting, pressures of parenting, self-acceptance, and learning and knowledge. 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. A higher overall score indicates greater self-efficacy.
Time Frame
baseline to 6 weeks and baseline to 4 months
Title
Group mean change at 6 weeks and 4 months on parenting skills on the Parenting Practices Interview
Description
Parenting Practices Interview is a standardized instrument to measure parenting skills. It includes three subscales: harsh discipline, inept discipline, and positive parenting. It includes 35 items on all rated on a 7-point scale. Higher scores in each subscale indicate greater frequency of the behavior.
Time Frame
baseline to 6 weeks and baseline to 4 months
Secondary Outcome Measure Information:
Title
Group mean change at 6 weeks and 4 months on substance use
Description
Substance use is collected using the Center on Parenting and Opioids substance use questionnaire. We will measure substance use as a both a dichotomous variable (using or not using) and as frequency of use of alcohol, cannabis, and illicit substances in the past thirty days.
Time Frame
baseline to 6 weeks and baseline to 4 months
Title
Group mean change at 4 months on child behavior
Description
Child behavior as measured by the Strengths and Difficulties Questionnaire prosocial behavior scale. This scale includes five items, rated on a 3-point scale ranging from 0 to 2. Higher scores indicate greater prosocial behavior.
Time Frame
baseline to 4 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Must identify as a father.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille C Cioffi, PhD
Organizational Affiliation
University of Oregon
Official's Role
Study Director
Facility Information:
Facility Name
Willamette Family Treatment Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97402
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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)
Citations:
PubMed Identifier
31489831
Citation
DeGarmo DS, Jones JA. Fathering Through Change (FTC) intervention for single fathers: Preventing coercive parenting and child problem behaviors. Dev Psychopathol. 2019 Dec;31(5):1801-1811. doi: 10.1017/S0954579419001019.
Results Reference
background
Learn more about this trial
A Substance Use Adaptation of Fathering Through Change
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