ParentingFTC-SUDNCT04532619

A Substance Use Adaptation of Fathering Through Change

A study testing Fathering Through Change in people with Parenting and Substance Use, run by University of Oregon at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Parenting, Substance Use
What is being tested?: Fathering Through Change
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2020to 31 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Willamette Family Treatment Center
Eugene, Oregon, 97402

Other trials in United States

About this study

Official title: 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.

Conditions: Parenting, Substance Use
Being tested: Fathering Through Change
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fathering Through ChangeBehavioural
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.

Study groups in NCT04532619
Study group	Role	What they receive
Intervention	Experimental	6 weeks of Fathering Through Change videos and 3 individual coaching calls. Receives: Behavioral: Fathering Through Change
Control	No intervention	Links to parenting websites

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: baseline to 6 weeks and baseline to 4 months
SDQ: Group Mean Change at 4 Months on Child Behavior
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.
Measured: baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202031 Dec 2021

First posted31 Aug 2020
Study start1 Jul 2020
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ParentingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04532619
Sponsor's protocol ID: 12132019.029
Acronym: FTC-SUD
Status last verified: Mar 2022
First submitted: 22 Jul 2020
Last updated: 8 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 31489831
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.
PubMed 37695329

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the Fathering Through Change Intervention for Fathers With Substance Use Disorders
ClinicalTrials.gov ID: NCT04532619
Acronym / sponsor ID: FTC-SUD / 12132019.029
Conditions: Parenting, Substance Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of OregonUniversity, hospital or other
Study start: 1 Jul 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 31 Aug 2020 (actual)
Results: Posted 8 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Fathering Through Change6 weeks of Fathering Through Change videos and 3 individual coaching calls.
Control	No intervention	–Links to parenting websites

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fathering Through ChangeFathering 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.	Behavioural	Intervention

Primary outcome

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.
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.
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.
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.

3 secondary outcomes

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: 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
SDQ: Group Mean Change at 4 Months on Child Behavior
Time frame: baseline to 4 months

Results and safety

Results posted to the registry on 8 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	21	18
Control	20	19

Primary outcome: 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. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Intervention n = 18	Control n = 19
6 weeks	8.77 (7.84 to 9.32)	7.50 (7.10 to 8.53)
4 months	8.70 (7.96 to 9.38)	7.65 (7.22 to 8.33)

Intervention vs Control: Slope: .5 (95% CI 0.10 to 0.89), p = 0.014, Mixed Models Analysis

Population analysed: Overall number analyzed is the number of participants with at least one follow-up.

Primary outcome: 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. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Intervention n = 18	Control n = 19
6 weeks	1.67 (1.33 to 2.83)	2.08 (1.71 to 2.62)
4 months	1.83 (1.33 to 2.00)	2.00 (1.50 to 2.83)

Intervention vs Control: Slope: -0.05 (95% CI -0.41 to 0.32), p = 0.80, Mixed Models Analysis

Population analysed: Overall number analyzed is the number of participants with at least one follow-up.

Primary outcome: 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. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Intervention n = 18	Control n = 19
6 weeks	2.09 (1.91 to 2.82)	2.91 (2.68 to 3.55)
4 months	2.09 (1.73 to 2.64)	2.64 (2.27 to 3.18)

Intervention vs Control: Slope: -0.29 (95% CI -0.51 to -0.07), p = 0.009, Mixed Models Analysis

Population analysed: Overall number analyzed is the number of participants with at least one follow-up.

Primary outcome: 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. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Intervention n = 18	Control n = 19
6 weeks	5.07 (4.67 to 5.40)	4.33 (4.17 to 4.77)
4 months	4.93 (4.60 to 5.40)	4.80 (4.07 to 5.00)

Intervention vs Control: Slope: 0.17 (95% CI -0.04 to 0.38), p = 0.118, Mixed Models Analysis

Population analysed: Overall number analyzed is the number of participants with at least one follow-up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Control	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): This was an underpowered randomized controlled trial. The purpose of the study was to assess feasibility of the Fathering In Recovery intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31489831DeGarmo 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.
Derived from this study: PubMed 37695329Cioffi 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Parenting

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"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Camille C Cioffi, PhD study director

University of Oregon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fathering Through Change in people with Parenting and Substance Use, run by University of Oregon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04532619, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.