NCT04532619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

November 8, 2024

Completed
Last Updated

November 8, 2024

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

July 22, 2020

Results QC Date

March 20, 2023

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy

    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

    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

    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

    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 Outcomes (3)

  • Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 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

    baseline to 6 weeks and baseline to 4 months

  • SDQ: Group Mean Change at 4 Months on Child Behavior

    baseline to 4 months

Study Arms (2)

Intervention

EXPERIMENTAL

6 weeks of Fathering Through Change videos and 3 individual coaching calls.

Behavioral: Fathering Through Change

Control

NO INTERVENTION

Links to parenting websites

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMust identify as a father.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Willamette Family Treatment Center

Eugene, Oregon, 97402, United States

Location

Related Publications (2)

  • 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.

    PMID: 31489831BACKGROUND
  • Cioffi CC, Browning O'Hagan AM, Halvorson S, DeGarmo DS. A randomized controlled trial to improve fathering among fathers with substance use disorders: Fathering in recovery intervention. J Fam Psychol. 2023 Dec;37(8):1303-1314. doi: 10.1037/fam0001134. Epub 2023 Sep 11.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

This was an underpowered randomized controlled trial. The purpose of the study was to assess feasibility of the Fathering In Recovery intervention.

Results Point of Contact

Title
Camille C. Cioffi
Organization
University of Oregon

Study Officials

  • Camille C Cioffi, PhD

    University of Oregon

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

August 31, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 8, 2024

Results First Posted

November 8, 2024

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The Center on Parenting and Opioids will determine the data's availability.
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)

Locations