Trial Outcomes & Findings for Pivotal Response Group Treatment for Parents of Young Children With Autism (NCT NCT01881750)
NCT ID: NCT01881750
Last Updated: 2019-08-16
Results Overview
Total frequency of child's utterances during 10 minute videotaped SLO assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2019-08-16
Participant Flow
Recruitment occurred over 2 years (July 2010-June 2012). Participants were recruited through distribution of fliers at clinics and autism awareness events, referral by local professionals, and word of mouth.
One hundred and thirty-five potential subjects were screened after inquiring about the study; 104 signed a consent form. Forty one did not meet eligibility criteria and 10 decided not to participate before baseline measures.
Participant milestones
| Measure |
Pivotal Response Training (PRT)
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Pivotal Response Training (PRT)
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Overall Study
Changes in concomitant therapies
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Pivotal Response Group Treatment for Parents of Young Children With Autism
Baseline characteristics by cohort
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=26 Participants
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Age, Categorical
<=18 years
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Total frequency of child's utterances during 10 minute videotaped SLO assessment.
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=25 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=22 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
Baseline Total Utterances of SLO
|
45.7 Utterances
Standard Deviation 23.1
|
40.8 Utterances
Standard Deviation 22.4
|
|
Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
Week 12 Total Utterances of SLO
|
64.5 Utterances
Standard Deviation 28.9
|
51.4 Utterances
Standard Deviation 33.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=26 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Parenting Stress Index Total Score
Baseline
|
92.04 score on a scale
Standard Deviation 25.07
|
98.38 score on a scale
Standard Deviation 26.97
|
|
Parenting Stress Index Total Score
12 Weeks
|
90.91 score on a scale
Standard Deviation 22.33
|
95.95 score on a scale
Standard Deviation 28.53
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=26 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Family Empowerment Scale Total Score
Baseline
|
127.78 score on a scale
Standard Deviation 18.18
|
121.73 score on a scale
Standard Deviation 19.91
|
|
Family Empowerment Scale Total Score
Week 12
|
130.14 score on a scale
Standard Deviation 18.78
|
121.68 score on a scale
Standard Deviation 14.25
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=26 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score
Baseline
|
124.19 score on a scale
Standard Deviation 21.17
|
124.19 score on a scale
Standard Deviation 24.69
|
|
Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score
Week 12
|
113.28 score on a scale
Standard Deviation 21.44
|
119.91 score on a scale
Standard Deviation 24.05
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=26 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Repetitive Behavior Scale- Revised Total Score
Baseline
|
21.70 score on a scale
Standard Deviation 14.62
|
26.23 score on a scale
Standard Deviation 22.70
|
|
Repetitive Behavior Scale- Revised Total Score
Week 12
|
20.04 score on a scale
Standard Deviation 16.69
|
30.05 score on a scale
Standard Deviation 24.78
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=25 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Sensory Profile Questionnaire Sensory Seeking Raw Score
Baseline
|
60.81 score on a scale
Standard Deviation 9.51
|
60.92 score on a scale
Standard Deviation 12.02
|
|
Sensory Profile Questionnaire Sensory Seeking Raw Score
Week 12
|
61.52 score on a scale
Standard Deviation 11.09
|
65.52 score on a scale
Standard Deviation 11.86
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants with available data.
Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).
Outcome measures
| Measure |
Pivotal Response Training (PRT)
n=27 Participants
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
|
Parent Education Group (PEG)
n=26 Participants
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
|
|---|---|---|
|
Pediatric Quality of Life Scale Scaled Total Mean Score
Baseline
|
64.86 score on a scale
Standard Deviation 15.72
|
67.18 score on a scale
Standard Deviation 15.66
|
|
Pediatric Quality of Life Scale Scaled Total Mean Score
Week 12
|
67.38 score on a scale
Standard Deviation 14.06
|
67.45 score on a scale
Standard Deviation 16.26
|
Adverse Events
Pivotal Response Training (PRT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent Education Group (PEG)
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
Antonio Hardan, MD
Stanford University School of Medicine
Phone: 650-736-1235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place