Trial Outcomes & Findings for Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach (NCT NCT02723916)
NCT ID: NCT02723916
Last Updated: 2020-12-31
Results Overview
Measured by the Parent Questionnaire (PQ) Scale scores reported: Warmth (scale range 1-5) - higher score indicates improvement Parent Follow Through (scale range 1-5) - higher score indicates improvement Corporal punishment (scale range 1-5) - lower score indicates improvement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
287 participants
Primary outcome timeframe
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Results posted on
2020-12-31
Participant Flow
Recruitment occurred from April 2016 - April 2018
No pre-assignment in study.
Participant milestones
| Measure |
Intervention: ezParent Program
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
143
|
|
Overall Study
COMPLETED
|
135
|
137
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach
Baseline characteristics by cohort
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 7.70 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
99 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=5 Participants
|
143 participants
n=7 Participants
|
287 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.Measured by the Parent Questionnaire (PQ) Scale scores reported: Warmth (scale range 1-5) - higher score indicates improvement Parent Follow Through (scale range 1-5) - higher score indicates improvement Corporal punishment (scale range 1-5) - lower score indicates improvement
Outcome measures
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Parenting Behaviors
Parental Warmth (T1)
|
4.30 score on a scale
Standard Deviation 0.46
|
4.27 score on a scale
Standard Deviation 0.41
|
|
Parenting Behaviors
Parental Warmth (T2)
|
4.26 score on a scale
Standard Deviation 0.42
|
4.25 score on a scale
Standard Deviation .41
|
|
Parenting Behaviors
Parental Warmth (T3)
|
4.29 score on a scale
Standard Deviation .39
|
4.3 score on a scale
Standard Deviation .44
|
|
Parenting Behaviors
Parental Warmth (T4)
|
4.27 score on a scale
Standard Deviation .46
|
4.34 score on a scale
Standard Deviation .4
|
|
Parenting Behaviors
Parental Follow Through (T1)
|
3.46 score on a scale
Standard Deviation 0.68
|
3.37 score on a scale
Standard Deviation 0.78
|
|
Parenting Behaviors
Parental Follow Through (T2)
|
3.47 score on a scale
Standard Deviation 0.75
|
3.49 score on a scale
Standard Deviation .71
|
|
Parenting Behaviors
Parental Follow Through (T3)
|
3.58 score on a scale
Standard Deviation .77
|
3.52 score on a scale
Standard Deviation .7
|
|
Parenting Behaviors
Parental Follow Through (T4)
|
3.64 score on a scale
Standard Deviation .75
|
3.59 score on a scale
Standard Deviation .76
|
|
Parenting Behaviors
Corporal Punishment (T1)
|
1.43 score on a scale
Standard Deviation 0.49
|
1.51 score on a scale
Standard Deviation 0.53
|
|
Parenting Behaviors
Corporal Punishment (T2)
|
1.47 score on a scale
Standard Deviation 0.55
|
1.49 score on a scale
Standard Deviation 0.55
|
|
Parenting Behaviors
Corporal Punishment (T3)
|
1.44 score on a scale
Standard Deviation .59
|
1.47 score on a scale
Standard Deviation .57
|
|
Parenting Behaviors
Corporal Punishment (T4)
|
1.42 score on a scale
Standard Deviation .58
|
1.39 score on a scale
Standard Deviation .5
|
SECONDARY outcome
Timeframe: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.Measured by the Parenting Young Children (PARYC) Reporting scales (scale range 1-7) (higher scores indicate more effective/improved parenting) Supporting good behavior Setting limits Proactive parenting
Outcome measures
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Change in Parent Behaviors
Supporting Good Behavior (T1)
|
5.63 score on a scale
Standard Deviation 0.96
|
5.70 score on a scale
Standard Deviation 0.98
|
|
Change in Parent Behaviors
Supporting Good Behavior (T2)
|
5.36 score on a scale
Standard Deviation 1.11
|
5.65 score on a scale
Standard Deviation 1.00
|
|
Change in Parent Behaviors
Supporting Good Behavior (T3)
|
5.54 score on a scale
Standard Deviation .99
|
5.7 score on a scale
Standard Deviation 1.07
|
|
Change in Parent Behaviors
Setting Limits (T1)
|
5.17 score on a scale
Standard Deviation 1.18
|
5.24 score on a scale
Standard Deviation 1.04
|
|
Change in Parent Behaviors
Supporting Good Behavior (T4)
|
5.53 score on a scale
Standard Deviation 1.15
|
5.85 score on a scale
Standard Deviation .87
|
|
Change in Parent Behaviors
Setting Limits (T2)
|
5.14 score on a scale
Standard Deviation 1.10
|
5.23 score on a scale
Standard Deviation 1.06
|
|
Change in Parent Behaviors
Setting Limits (T3)
|
5.31 score on a scale
Standard Deviation 1.07
|
5.37 score on a scale
Standard Deviation 1.19
|
|
Change in Parent Behaviors
Setting Limits (T4)
|
5.41 score on a scale
Standard Deviation 1.10
|
5.52 score on a scale
Standard Deviation 1.12
|
|
Change in Parent Behaviors
Proactive Parenting (T1)
|
5.08 score on a scale
Standard Deviation 1.32
|
5.13 score on a scale
Standard Deviation 1.27
|
|
Change in Parent Behaviors
Proactive Parenting (T2)
|
5.04 score on a scale
Standard Deviation 1.12
|
5.08 score on a scale
Standard Deviation 1.26
|
|
Change in Parent Behaviors
Proactive Parenting (T3)
|
5.2 score on a scale
Standard Deviation 1.26
|
5.3 score on a scale
Standard Deviation 1.21
|
|
Change in Parent Behaviors
Proactive Parenting (T4)
|
5.29 score on a scale
Standard Deviation 1.27
|
5.48 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.Strengths and Difficulties Questionnaire (SDQ) scales (range 0-10) Emotional symptoms (higher scores indicate more difficulties) Conduct problems (higher scores indicate more difficulties) Hyperactivity/inattention (higher scores indicate more difficulties) Peer relationship problems (higher scores indicate more difficulties) Prosocial behavior (higher scores indicate more strengths)
Outcome measures
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Change in Child Behavior Problems
Conduct (T1)
|
1.93 score on a scale
Standard Deviation 1.90
|
1.94 score on a scale
Standard Deviation 1.77
|
|
Change in Child Behavior Problems
Emotion (T1)
|
1.06 score on a scale
Standard Deviation 1.39
|
1.12 score on a scale
Standard Deviation 1.33
|
|
Change in Child Behavior Problems
Emotion (T2)
|
1.1 score on a scale
Standard Deviation 1.61
|
1.03 score on a scale
Standard Deviation 1.21
|
|
Change in Child Behavior Problems
Emotion (T3)
|
1.02 score on a scale
Standard Deviation 1.43
|
.97 score on a scale
Standard Deviation 1.36
|
|
Change in Child Behavior Problems
Emotion (T4)
|
1.03 score on a scale
Standard Deviation 1.44
|
.92 score on a scale
Standard Deviation 1.23
|
|
Change in Child Behavior Problems
Conduct (T2)
|
1.63 score on a scale
Standard Deviation 1.79
|
1.77 score on a scale
Standard Deviation 1.64
|
|
Change in Child Behavior Problems
Conduct (T3)
|
1.56 score on a scale
Standard Deviation 1.83
|
1.75 score on a scale
Standard Deviation 1.76
|
|
Change in Child Behavior Problems
Conduct (T4)
|
1.4 score on a scale
Standard Deviation 1.81
|
1.53 score on a scale
Standard Deviation 1.52
|
|
Change in Child Behavior Problems
Hyper (T1)
|
3.50 score on a scale
Standard Deviation 2.29
|
3.38 score on a scale
Standard Deviation 2.28
|
|
Change in Child Behavior Problems
Hyper (T2)
|
3.18 score on a scale
Standard Deviation 2.26
|
3.46 score on a scale
Standard Deviation 2.22
|
|
Change in Child Behavior Problems
Hyper (T3)
|
3.09 score on a scale
Standard Deviation 2.49
|
2.91 score on a scale
Standard Deviation 2.14
|
|
Change in Child Behavior Problems
Hyper (T4)
|
3.09 score on a scale
Standard Deviation 2.32
|
2.84 score on a scale
Standard Deviation 2.2
|
|
Change in Child Behavior Problems
Peer (T1)
|
1.62 score on a scale
Standard Deviation 1.56
|
1.52 score on a scale
Standard Deviation 1.64
|
|
Change in Child Behavior Problems
Peer (T2)
|
1.4 score on a scale
Standard Deviation 1.6
|
1.53 score on a scale
Standard Deviation 1.56
|
|
Change in Child Behavior Problems
Peer (T3)
|
1.27 score on a scale
Standard Deviation 1.41
|
1.31 score on a scale
Standard Deviation 1.47
|
|
Change in Child Behavior Problems
Peer (T4)
|
1.49 score on a scale
Standard Deviation 1.71
|
1.45 score on a scale
Standard Deviation 1.57
|
|
Change in Child Behavior Problems
Prosocial (T1)
|
8.01 score on a scale
Standard Deviation 1.94
|
8.26 score on a scale
Standard Deviation 1.74
|
|
Change in Child Behavior Problems
Prosocial (T2)
|
8.43 score on a scale
Standard Deviation 1.94
|
8.24 score on a scale
Standard Deviation 1.96
|
|
Change in Child Behavior Problems
Prosocial (T3
|
8.5 score on a scale
Standard Deviation 1.81
|
8.6 score on a scale
Standard Deviation 1.55
|
|
Change in Child Behavior Problems
Prosocial (T4)
|
8.72 score on a scale
Standard Deviation 1.92
|
8.45 score on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.Population: Severity (intensity scale) 1 = never happens to 7 = always happening (higher scores more intense problems) - range is 1-7 Frequency (problem Scale of child behaviors. 0 = no; 1 = yes (higher scores more problems) Range 0-1 T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Eyberg Child Behavior Inventory (ECBI) Problem scale (range 0-1) higher scores more problems Intensity scale (range 1-7) higher scores more intense problems
Outcome measures
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Change in Child Externalizing Behavior Problems
Problem Scale (T1)
|
0.18 score on a scale
Standard Deviation 0.22
|
0.19 score on a scale
Standard Deviation 0.21
|
|
Change in Child Externalizing Behavior Problems
Problem Scale (T2)
|
.14 score on a scale
Standard Deviation .18
|
.16 score on a scale
Standard Deviation .19
|
|
Change in Child Externalizing Behavior Problems
Problem Scale (T3)
|
.14 score on a scale
Standard Deviation .2
|
.15 score on a scale
Standard Deviation .19
|
|
Change in Child Externalizing Behavior Problems
Problem Scale (T4)
|
.12 score on a scale
Standard Deviation .18
|
.13 score on a scale
Standard Deviation .19
|
|
Change in Child Externalizing Behavior Problems
Intensity Scale (T1)
|
2.80 score on a scale
Standard Deviation 0.84
|
2.84 score on a scale
Standard Deviation 0.80
|
|
Change in Child Externalizing Behavior Problems
Intensity Scale (T2)
|
2.69 score on a scale
Standard Deviation .85
|
2.69 score on a scale
Standard Deviation .72
|
|
Change in Child Externalizing Behavior Problems
Intensity Scale (T3)
|
2.64 score on a scale
Standard Deviation .8
|
2.67 score on a scale
Standard Deviation .75
|
|
Change in Child Externalizing Behavior Problems
Intensity Scale (T4)
|
2.64 score on a scale
Standard Deviation .74
|
2.56 score on a scale
Standard Deviation .74
|
SECONDARY outcome
Timeframe: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.Parenting Stress Index-Short Form (PSI-SF) Scales (range 12-60): Higher scores indicate higher stress Parental distress Parent-child dysfunctional interaction Difficult child
Outcome measures
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Change in Parenting Stress
Parent Domain (T1)
|
26.06 score on a scale
Standard Deviation 9.58
|
25.53 score on a scale
Standard Deviation 7.86
|
|
Change in Parenting Stress
Parent Domain (T2)
|
25.9 score on a scale
Standard Deviation 9.26
|
25.25 score on a scale
Standard Deviation 8.17
|
|
Change in Parenting Stress
Parent Domain (T3)
|
25.39 score on a scale
Standard Deviation 10.04
|
25.41 score on a scale
Standard Deviation 9.56
|
|
Change in Parenting Stress
Parent Domain (T4)
|
25.3 score on a scale
Standard Deviation 9.72
|
24.64 score on a scale
Standard Deviation 8.18
|
|
Change in Parenting Stress
Parent-Child Domain (T1)
|
20.28 score on a scale
Standard Deviation 6.38
|
19.76 score on a scale
Standard Deviation 6.05
|
|
Change in Parenting Stress
Parent-Child Domain (T2)
|
19.62 score on a scale
Standard Deviation 6.5
|
20.02 score on a scale
Standard Deviation 5.79
|
|
Change in Parenting Stress
Parent-Child Domain (T3)
|
19.62 score on a scale
Standard Deviation 6.53
|
19.7 score on a scale
Standard Deviation 6.87
|
|
Change in Parenting Stress
Parent-Child Domain (T4)
|
19.52 score on a scale
Standard Deviation 6.03
|
19.62 score on a scale
Standard Deviation 6.07
|
|
Change in Parenting Stress
Child Domain (T1)
|
24.72 score on a scale
Standard Deviation 8.02
|
24.24 score on a scale
Standard Deviation 6.86
|
|
Change in Parenting Stress
Child Domain (T2)
|
23.97 score on a scale
Standard Deviation 7.62
|
24.34 score on a scale
Standard Deviation 7.29
|
|
Change in Parenting Stress
Child Domain (T3)
|
23.37 score on a scale
Standard Deviation 7.45
|
23.46 score on a scale
Standard Deviation 7.66
|
|
Change in Parenting Stress
Child Domain (T4)
|
23.11 score on a scale
Standard Deviation 7.18
|
23.18 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.Parenting Sense of Competence Scale (PSOC) - Total Scale (Range 17-102) Higher scores indicate higher self efficacy
Outcome measures
| Measure |
Intervention: ezParent Program
n=144 Participants
ezParent Program: Tablet-based behavioral parent training program.
|
Control: Health-e Kids App
n=143 Participants
Health-e Kids Control App: Tablet based health promotion information App
|
|---|---|---|
|
Change in Parenting Self-efficacy
Total Score (T1)
|
71.07 score on a scale
Standard Deviation 11.41
|
71.28 score on a scale
Standard Deviation 10.62
|
|
Change in Parenting Self-efficacy
Total Score (T2)
|
71.51 score on a scale
Standard Deviation 11.20
|
70.94 score on a scale
Standard Deviation 10.7
|
|
Change in Parenting Self-efficacy
Total Score (T3)
|
72.99 score on a scale
Standard Deviation 11.16
|
71.73 score on a scale
Standard Deviation 12.24
|
|
Change in Parenting Self-efficacy
Total Score (T4)
|
72.9 score on a scale
Standard Deviation 12.10
|
72.1 score on a scale
Standard Deviation 11.00
|
Adverse Events
Intervention: ezParent Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control: Health-e Kids App
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. Susie Breitenstein
The Ohio State University, College of Nursing
Phone: 6146884614
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place