Trial Outcomes & Findings for Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two (NCT NCT01424943)
NCT ID: NCT01424943
Last Updated: 2019-04-18
Results Overview
Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline, 5 months
Results posted on
2019-04-18
Participant Flow
Participant milestones
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
IDEA Part C services as usual based on IFSP
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
12
|
23
|
|
Overall Study
NOT COMPLETED
|
13
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two
Baseline characteristics by cohort
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
n=25 Participants
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
n=24 Participants
IDEA Part C services as usual based on IFSP
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.77 months
STANDARD_DEVIATION 3.64 • n=5 Participants
|
19.25 months
STANDARD_DEVIATION 3.13 • n=7 Participants
|
19.00 months
STANDARD_DEVIATION 3.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 5 monthsParenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.
Outcome measures
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
n=25 Participants
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
n=24 Participants
IDEA Part C services as usual based on IFSP
|
|---|---|---|
|
Parenting Style
baseline Parenting Scale
|
2.65 scores on a scale
Standard Deviation .57
|
2.61 scores on a scale
Standard Deviation .70
|
|
Parenting Style
Post-Tx Parenting Scale
|
2.09 scores on a scale
Standard Deviation .73
|
2.21 scores on a scale
Standard Deviation .66
|
PRIMARY outcome
Timeframe: Baseline, 5 monthsChild Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.
Outcome measures
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
n=25 Participants
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
n=24 Participants
IDEA Part C services as usual based on IFSP
|
|---|---|---|
|
Child Behavior
CBCL Total Score Baseline
|
53.56 T-score
Standard Deviation 8.54
|
51.00 T-score
Standard Deviation 10.67
|
|
Child Behavior
CBCL Total Score Post-Tx
|
53.45 T-score
Standard Deviation 10.91
|
51.61 T-score
Standard Deviation 9.09
|
PRIMARY outcome
Timeframe: Baseline, 5 monthsToddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.
Outcome measures
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
n=25 Participants
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
n=24 Participants
IDEA Part C services as usual based on IFSP
|
|---|---|---|
|
Parenting Self-confidence
baseline
|
152.32 units on a scale
Standard Deviation 21.93
|
155.13 units on a scale
Standard Deviation 19.19
|
|
Parenting Self-confidence
midpoint
|
157.45 units on a scale
Standard Deviation 19.68
|
159.17 units on a scale
Standard Deviation 14.65
|
PRIMARY outcome
Timeframe: Baseline, 5 monthsKIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.
Outcome measures
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
n=25 Participants
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
n=24 Participants
IDEA Part C services as usual based on IFSP
|
|---|---|---|
|
KIPS
Scores at 5 months
|
3.52 scores on a scale
Standard Deviation .70
|
3.52 scores on a scale
Standard Deviation .63
|
|
KIPS
scores at Baseline
|
3.39 scores on a scale
Standard Deviation .54
|
3.52 scores on a scale
Standard Deviation .59
|
SECONDARY outcome
Timeframe: baseline, 5 monthsDASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.
Outcome measures
| Measure |
Stepping Stones Triple P Plus IDEA Part C Services as Usual
n=25 Participants
10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes
Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP.
|
IDEA Part C Services As Usual
n=24 Participants
IDEA Part C services as usual based on IFSP
|
|---|---|---|
|
Parent Symptoms of Depression, Anxiety and Stress
5 month DASS 21 Depression
|
3.00 scores on a scale
Standard Deviation 4.22
|
4.09 scores on a scale
Standard Deviation 5.92
|
|
Parent Symptoms of Depression, Anxiety and Stress
5 month DASS 21 Anxiety
|
3.45 scores on a scale
Standard Deviation 3.56
|
2.96 scores on a scale
Standard Deviation 5.25
|
|
Parent Symptoms of Depression, Anxiety and Stress
5 month DASS 21 Stress
|
9.55 scores on a scale
Standard Deviation 6.35
|
10.70 scores on a scale
Standard Deviation 9.12
|
|
Parent Symptoms of Depression, Anxiety and Stress
baseline DASS 21 depression
|
4.80 scores on a scale
Standard Deviation 6.16
|
4.58 scores on a scale
Standard Deviation 9.16
|
|
Parent Symptoms of Depression, Anxiety and Stress
baseline DASS 21 anxiety
|
3.68 scores on a scale
Standard Deviation 5.59
|
3.50 scores on a scale
Standard Deviation 7.11
|
|
Parent Symptoms of Depression, Anxiety and Stress
baseline DASS 21 stress
|
11.20 scores on a scale
Standard Deviation 6.98
|
10.83 scores on a scale
Standard Deviation 8.50
|
Adverse Events
Stepping Stones Triple P Plus IDEA Part C Services as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IDEA Part C Services As Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Cheri Shapiro
Institute for Families in Society, University of South Carolina
Phone: 803-777-8760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place