Trial Outcomes & Findings for A Substance Use Adaptation of Fathering Through Change (NCT NCT04532619)
NCT ID: NCT04532619
Last Updated: 2024-11-08
Results Overview
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.
COMPLETED
NA
41 participants
baseline to 6 weeks and baseline to 4 months
2024-11-08
Participant Flow
Recruited from substance use disorder treatment centers
No pre-assignment details to report
Participant milestones
| Measure |
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.
|
Control
Links to parenting websites
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Complete scores
Baseline characteristics by cohort
| Measure |
Intervention
n=21 Participants
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.
|
Control
n=20 Participants
Links to parenting websites
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=21 Participants
|
20 Participants
n=20 Participants
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
40 years
n=21 Participants
|
35 years
n=20 Participants
|
39 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=21 Participants
|
20 Participants
n=20 Participants
|
41 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=21 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=21 Participants
|
16 Participants
n=20 Participants
|
34 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=21 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=21 Participants
|
11 Participants
n=20 Participants
|
28 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=21 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=41 Participants
|
|
TOPSE: Parenting Self-Efficacy
|
7.78 units on a scale
n=21 Participants
|
7.87 units on a scale
n=20 Participants
|
7.78 units on a scale
n=41 Participants
|
|
Parenting Practices: Harsh parenting
|
2.08 units on a scale
n=20 Participants • Complete scores
|
2.17 units on a scale
n=20 Participants • Complete scores
|
2.17 units on a scale
n=40 Participants • Complete scores
|
|
Parenting Practices: Inept parenting
|
2.5 units on a scale
n=20 Participants • Complete scores
|
3.00 units on a scale
n=20 Participants • Complete scores
|
2.64 units on a scale
n=40 Participants • Complete scores
|
|
Parenting Practices: Prosocial parenting
|
4.87 units on a scale
n=20 Participants • Complete scores
|
4.27 units on a scale
n=20 Participants • Complete scores
|
4.60 units on a scale
n=40 Participants • Complete scores
|
|
Substance Use: Any Use in the Last 30 Days
|
4 Participants
n=20 Participants • Non-missing values
|
7 Participants
n=20 Participants • Non-missing values
|
11 Participants
n=40 Participants • Non-missing values
|
|
Substance Use: Days of Use the Last 30
|
0 Days
n=21 Participants
|
0 Days
n=20 Participants
|
0 Days
n=41 Participants
|
|
Child Behavior: Strengths and Difficulties Questionnaire
|
11 units on a scale
n=20 Participants • Complete scores
|
11 units on a scale
n=20 Participants • Complete scores
|
11 units on a scale
n=40 Participants • Complete scores
|
PRIMARY outcome
Timeframe: baseline to 6 weeks and baseline to 4 monthsPopulation: Overall number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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.
|
Control
n=19 Participants
Links to parenting websites
|
|---|---|---|
|
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
Interval 7.84 to 9.32
|
7.50 score on a scale
Interval 7.1 to 8.53
|
|
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
Interval 7.96 to 9.38
|
7.65 score on a scale
Interval 7.22 to 8.33
|
PRIMARY outcome
Timeframe: baseline to 6 weeks and baseline to 4 monthsPopulation: Overall number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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.
|
Control
n=19 Participants
Links to parenting websites
|
|---|---|---|
|
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
Interval 1.33 to 2.83
|
2.08 units on a scale
Interval 1.71 to 2.62
|
|
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
Interval 1.33 to 2.0
|
2.00 units on a scale
Interval 1.5 to 2.83
|
PRIMARY outcome
Timeframe: baseline to 6 weeks and baseline to 4 monthsPopulation: Overall number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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.
|
Control
n=19 Participants
Links to parenting websites
|
|---|---|---|
|
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
Interval 1.91 to 2.82
|
2.91 units on a scale
Interval 2.68 to 3.55
|
|
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
Interval 1.73 to 2.64
|
2.64 units on a scale
Interval 2.27 to 3.18
|
PRIMARY outcome
Timeframe: baseline to 6 weeks and baseline to 4 monthsPopulation: Overall number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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.
|
Control
n=19 Participants
Links to parenting websites
|
|---|---|---|
|
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
Interval 4.67 to 5.4
|
4.33 units on a scale
Interval 4.17 to 4.77
|
|
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
Interval 4.6 to 5.4
|
4.80 units on a scale
Interval 4.07 to 5.0
|
SECONDARY outcome
Timeframe: baseline to 6 weeks and baseline to 4 monthsPopulation: Number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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.
|
Control
n=19 Participants
Links to parenting websites
|
|---|---|---|
|
Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days
6 weeks
|
4 Participants
|
6 Participants
|
|
Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days
4 months
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: baseline to 6 weeks and baseline to 4 monthsPopulation: Number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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.
|
Control
n=19 Participants
Links to parenting websites
|
|---|---|---|
|
Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30
6 weeks
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 2.5
|
|
Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30
4 months
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: baseline to 4 monthsPopulation: Overall number analyzed is the number of participants with at least one follow-up.
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.
Outcome measures
| Measure |
Intervention
n=16 Participants
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.
|
Control
n=16 Participants
Links to parenting websites
|
|---|---|---|
|
SDQ: Group Mean Change at 4 Months on Child Behavior
|
9 units on a scale
Interval 4.5 to 11.0
|
16 units on a scale
Interval 6.75 to 21.0
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place