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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 6 weeks of Fathering Through Change videos and 3 individual coaching calls. |
|
| Control | No Intervention | Links to parenting websites |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fathering Through Change | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 6 weeks and baseline to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
-
Must identify as a father.
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| Name | Affiliation | Role |
|---|---|---|
| Camille C Cioffi, PhD | University of Oregon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Willamette Family Treatment Center | Eugene | Oregon | 97402 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31489831 | Background | 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. | |
| 37695329 | Derived | 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. |
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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.
The Center on Parenting and Opioids will determine the data's availability.
Initially only to Center on Parenting and Opioids researchers. Future public access will be determined by the Center on Parenting and Opioids (PI: Leve)
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No pre-assignment details to report
Recruited from substance use disorder treatment centers
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 6 weeks of Fathering Through Change videos and 3 individual coaching calls. Fathering Through Change: 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. |
| FG001 | Control | Links to parenting websites |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 6 weeks of Fathering Through Change videos and 3 individual coaching calls. Fathering Through Change: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Overall number analyzed is the number of participants with at least one follow-up. | Posted | Median | Inter-Quartile Range | score on a scale | baseline to 6 weeks and baseline to 4 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 6 weeks of Fathering Through Change videos and 3 individual coaching calls. Fathering Through Change: 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. |
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This was an underpowered randomized controlled trial. The purpose of the study was to assess feasibility of the Fathering In Recovery intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Camille C. Cioffi | University of Oregon | 541-525-4886 | ccioffi@uoregon.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2021 | Aug 23, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2023 | Aug 23, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2020 | Aug 23, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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. | 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. | baseline to 4 months |
| BG001 |
| Control |
Links to parenting websites |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| TOPSE: 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. | Median | Inter-Quartile Range | units on a scale |
|
| Parenting Practices: Harsh parenting | 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. | Complete scores | Median | Inter-Quartile Range | units on a scale |
|
| Parenting Practices: Inept parenting | 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. | Complete scores | Median | Inter-Quartile Range | units on a scale |
|
| Parenting Practices: Prosocial parenting | Parenting Practices Interview is a standardized instrument to measure parenting skills. The prosocial parenting sub-scale is computed as the average (1-7) of 15 items. Higher scores are more desirable. | Complete scores | Median | Inter-Quartile Range | units on a scale |
|
| Substance Use: 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. | Non-missing values | Count of Participants | Participants |
|
| Substance Use: Days of Use the Last 30 | Substance use is collected using the Center on Parenting and Opioids substance use questionnaire. We measured substance use continuous variable: number of days using of alcohol, cannabis, and illicit substances in the past thirty days. | Median | Inter-Quartile Range | Days |
|
| Child Behavior: Strengths and Difficulties Questionnaire | 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 sub-scales each composed of 5 items: emotional regulation, conduct, hyperactivity, peer problems, and prosocial behavior. The prosocial sub-scale was not used for analyses and the twenty items remaining were summed into an overall score (0-40). Higher scores are more desirable. | Complete scores | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Control | Links to parenting websites |
|
|
|
| Primary | 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. | Overall number analyzed is the number of participants with at least one follow-up. | Posted | Median | Inter-Quartile Range | units on a scale | baseline to 6 weeks and baseline to 4 months |
|
|
|
|
| Primary | 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. | Overall number analyzed is the number of participants with at least one follow-up. | Posted | Median | Inter-Quartile Range | units on a scale | baseline to 6 weeks and baseline to 4 months |
|
|
|
|
| Primary | 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. | Overall number analyzed is the number of participants with at least one follow-up. | Posted | Median | Inter-Quartile Range | units on a scale | baseline to 6 weeks and baseline to 4 months |
|
|
|
|
| Secondary | 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. | Number analyzed is the number of participants with at least one follow-up. | Posted | Count of Participants | Participants | baseline to 6 weeks and baseline to 4 months |
|
|
|
|
| Secondary | 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. | Number analyzed is the number of participants with at least one follow-up. | Posted | Median | Inter-Quartile Range | days | baseline to 6 weeks and baseline to 4 months |
|
|
|
|
| Secondary | 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. | Overall number analyzed is the number of participants with at least one follow-up. | Posted | Median | Inter-Quartile Range | units on a scale | baseline to 4 months |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Control | Links to parenting websites | 0 | 20 | 0 | 20 | 0 | 20 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| 4 months |
|
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| 4 months |
|
|
| 4 months |
|
|
| 4 months |
|
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