Trial Outcomes & Findings for Early Parenting Intervention Comparison (NCT NCT01517867)
NCT ID: NCT01517867
Last Updated: 2018-05-03
Results Overview
parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
baseline, first follow-up (up to 2 years)
Results posted on
2018-05-03
Participant Flow
Participant milestones
| Measure |
Intervention Chicago Parent Program Arm
The Chicago Parent Program is a 12-session group-based parenting skills training program
Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
|
Parent-Child Interaction Therapy
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
80
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
63
|
65
|
Reasons for withdrawal
| Measure |
Intervention Chicago Parent Program Arm
The Chicago Parent Program is a 12-session group-based parenting skills training program
Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
|
Parent-Child Interaction Therapy
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
|
|---|---|---|
|
Overall Study
never started treatment
|
29
|
32
|
|
Overall Study
Withdrawal by Subject
|
34
|
30
|
|
Overall Study
Still in treatment at study end
|
0
|
3
|
Baseline Characteristics
Early Parenting Intervention Comparison
Baseline characteristics by cohort
| Measure |
Intervention Chicago Parent Program Arm
n=81 Participants
The Chicago Parent Program is a 12-session group-based parenting skills training program
Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
|
Parent-Child Interaction Therapy
n=80 Participants
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 years
n=99 Participants
|
34.5 years
n=107 Participants
|
33.76 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
55 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
81 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, first follow-up (up to 2 years)Population: First follow-up data collected from 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect follow-up data from remaining participants who enrolled in study but never attended any treatment.
parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.
Outcome measures
| Measure |
Intervention Chicago Parent Program Arm
n=42 Participants
The Chicago Parent Program is a 12-session group-based parenting skills training program
Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
|
Parent-Child Interaction Therapy
n=34 Participants
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
|
|---|---|---|
|
Change in Child Behavior Problems
Baseline
|
67.0 units on a scale
Standard Deviation 13.42
|
67.6 units on a scale
Standard Deviation 11.75
|
|
Change in Child Behavior Problems
first follow-up (up to 2 years)
|
60.4 units on a scale
Standard Deviation 12.92
|
59.9 units on a scale
Standard Deviation 13.34
|
SECONDARY outcome
Timeframe: through end of study (up to 2 years)Population: Cost collected for 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect cost data from the remaining participants who enrolled in study but never attended any treatment.
Combined provider (based on billing records) and parent cost (based on self-report).
Outcome measures
| Measure |
Intervention Chicago Parent Program Arm
n=42 Participants
The Chicago Parent Program is a 12-session group-based parenting skills training program
Chicago Parent Program: The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
|
Parent-Child Interaction Therapy
n=34 Participants
Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems
Parent-Child Interaction Therapy: Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
|
|---|---|---|
|
Aggregate Cost
|
1413 dollars
Standard Deviation 1211
|
2151 dollars
Standard Deviation 2583
|
Adverse Events
Intervention Chicago Parent Program Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent-Child Interaction Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place