Parenting, Substance Use
Conditions
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.
Interventions
BEHAVIORALFathering 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.
Sponsors
University of Oregon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| SDQ: Group Mean Change at 4 Months on Child Behavior | 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. |
| 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 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. |
Countries
United States
Participant flow
Recruitment details
Recruited from substance use disorder treatment centers
Pre-assignment details
No pre-assignment details to report
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Control Links to parenting websites | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 20 Participants | 41 Participants |
| Age, Continuous | 40 years | 35 years | 39 years |
| Child Behavior: Strengths and Difficulties Questionnaire | 11 units on a scale | 11 units on a scale | 11 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 16 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parenting Practices: Harsh parenting | 2.08 units on a scale | 2.17 units on a scale | 2.17 units on a scale |
| Parenting Practices: Inept parenting | 2.5 units on a scale | 3.00 units on a scale | 2.64 units on a scale |
| Parenting Practices: Prosocial parenting | 4.87 units on a scale | 4.27 units on a scale | 4.60 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 41 Participants |
| Substance Use: Any Use in the Last 30 Days | 4 Participants | 7 Participants | 11 Participants |
| Substance Use: Days of Use the Last 30 | 0 Days | 0 Days | 0 Days |
| TOPSE: Parenting Self-Efficacy | 7.78 units on a scale | 7.87 units on a scale | 7.78 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: baseline to 6 weeks and baseline to 4 months
Population: Overall number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | PPI Harsh: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Harsh Parenting Subscale | 6 weeks | 1.67 units on a scale |
| Intervention | PPI Harsh: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Harsh Parenting Subscale | 4 months | 1.83 units on a scale |
| Control | PPI Harsh: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Harsh Parenting Subscale | 6 weeks | 2.08 units on a scale |
| Control | PPI Harsh: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Harsh Parenting Subscale | 4 months | 2.00 units on a scale |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.p-value: 0.895% CI: [-0.41, 0.32]Mixed Models Analysis
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.
Time frame: baseline to 6 weeks and baseline to 4 months
Population: Overall number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | PPI Inept: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Inept Parenting Subscale | 6 weeks | 2.09 units on a scale |
| Intervention | PPI Inept: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Inept Parenting Subscale | 4 months | 2.09 units on a scale |
| Control | PPI Inept: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Inept Parenting Subscale | 6 weeks | 2.91 units on a scale |
| Control | PPI Inept: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Inept Parenting Subscale | 4 months | 2.64 units on a scale |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.p-value: 0.00995% CI: [-0.51, -0.07]Mixed Models Analysis
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.
Time frame: baseline to 6 weeks and baseline to 4 months
Population: Overall number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | PPI Prosocial: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Prosocial Parenting Subscale | 6 weeks | 5.07 units on a scale |
| Intervention | PPI Prosocial: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Prosocial Parenting Subscale | 4 months | 4.93 units on a scale |
| Control | PPI Prosocial: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Prosocial Parenting Subscale | 6 weeks | 4.33 units on a scale |
| Control | PPI Prosocial: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Prosocial Parenting Subscale | 4 months | 4.80 units on a scale |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.p-value: 0.11895% CI: [-0.04, 0.38]Mixed Models Analysis
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.
Time frame: baseline to 6 weeks and baseline to 4 months
Population: Overall number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy | 6 weeks | 8.77 score on a scale |
| Intervention | TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy | 4 months | 8.70 score on a scale |
| Control | TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy | 6 weeks | 7.50 score on a scale |
| Control | TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy | 4 months | 7.65 score on a scale |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.p-value: 0.01495% CI: [0.1, 0.89]Mixed Models Analysis
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.
Time frame: baseline to 4 months
Population: Overall number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | SDQ: Group Mean Change at 4 Months on Child Behavior | 9 units on a scale |
| Control | SDQ: Group Mean Change at 4 Months on Child Behavior | 16 units on a scale |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.p-value: 0.0795% CI: [-4.27, 0.15]Mixed Models Analysis
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.
Time frame: baseline to 6 weeks and baseline to 4 months
Population: Number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days | 4 months | 4 Participants |
| Intervention | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days | 6 weeks | 4 Participants |
| Control | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days | 4 months | 8 Participants |
| Control | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days | 6 weeks | 6 Participants |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology. A logistic link function was used for this binary outcome.p-value: 0.24Mixed Models Analysis
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.
Time frame: baseline to 6 weeks and baseline to 4 months
Population: Number analyzed is the number of participants with at least one follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30 | 6 weeks | 0 days |
| Intervention | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30 | 4 months | 0 days |
| Control | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30 | 6 weeks | 0 days |
| Control | Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30 | 4 months | 0 days |
Comparison: We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.p-value: 0.4395% CI: [-4.64, 1.98]Mixed Models Analysis