Trial Outcomes & Findings for CPI Training for Parents of Children With ASD (NCT NCT03537261)
NCT ID: NCT03537261
Last Updated: 2021-06-29
Results Overview
The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy and a positive change indicating improvement from baseline. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.
COMPLETED
NA
81 participants
Baseline and 2-weeks
2021-06-29
Participant Flow
One participant withdrew consent prior to randomization.
Participant milestones
| Measure |
CPI-Parent Training
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
|
Waitlist Control
Will not receive active P-CPI training during the experimental treatment interval.
NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
Completed Baseline Assessment
|
35
|
28
|
|
Overall Study
COMPLETED
|
33
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
CPI-Parent Training
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
|
Waitlist Control
Will not receive active P-CPI training during the experimental treatment interval.
NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Did not return study questionnaires
|
0
|
1
|
Baseline Characteristics
CPI Training for Parents of Children With ASD
Baseline characteristics by cohort
| Measure |
CPI-Parent Training
n=35 Participants
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
|
Waitlist Control
n=28 Participants
Will not receive active P-CPI training during the experimental treatment interval.
NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
60 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 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
|
35 participants
n=99 Participants
|
28 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score
|
111.3 units on a scale
STANDARD_DEVIATION 21.8 • n=99 Participants
|
101.3 units on a scale
STANDARD_DEVIATION 17.8 • n=107 Participants
|
106.8 units on a scale
STANDARD_DEVIATION 20.6 • n=206 Participants
|
|
Parent Stress Index - Short Form Total Score
|
115.0 units on a scale
STANDARD_DEVIATION 19.4 • n=99 Participants
|
117.6 units on a scale
STANDARD_DEVIATION 21.0 • n=107 Participants
|
116.2 units on a scale
STANDARD_DEVIATION 20.0 • n=206 Participants
|
|
Family Quality of Life Scale Total Score
|
93.3 units on a scale
STANDARD_DEVIATION 11.8 • n=99 Participants
|
90.5 units on a scale
STANDARD_DEVIATION 13.9 • n=107 Participants
|
92.1 units on a scale
STANDARD_DEVIATION 12.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2-weeksPopulation: All 35 participants assigned to P-CPI training and 28 participants assigned to waitlist who completed the baseline assessment contributed at least one CAPES-DD self-efficacy total score to the analysis. Five of these participants contributed only one score: two assigned to P-CPI training and one assigned to waitlist who discontinued study participation between baseline and two weeks, and one at baseline and one at two weeks assigned to P-CPI training who provided incomplete CAPES-DD data.
The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy and a positive change indicating improvement from baseline. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.
Outcome measures
| Measure |
CPI-Parent Training
n=35 Participants
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
|
Waitlist Control
n=28 Participants
Will not receive active P-CPI training during the experimental treatment interval.
NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.
|
|---|---|---|
|
Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score
|
8.3 units on a scale
Interval 3.3 to 13.3
|
2.5 units on a scale
Interval -2.9 to 7.8
|
SECONDARY outcome
Timeframe: Baseline and 2-weeksPopulation: All 35 participants assigned to P-CPI training and 28 participants assigned to waitlist who completed the baseline assessment contributed at least one PSI-SF total score to the analysis. Five of these participants contributed only one score: two assigned to P-CPI training and one assigned to waitlist who discontinued study participation between baseline and two weeks, and two at two weeks assigned to P-CPI training who provided incomplete PSI-SF data or did not complete the scale.
The PSI-SF is a self-report measure of severity and domain of parenting stress which includes 36 items rated on a 5-point, Likert scale. The range of possible values for the total stress raw score is 36-180, with higher scores corresponding to greater levels of parental stress and negative change corresponding to reduced levels of parental stress. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.
Outcome measures
| Measure |
CPI-Parent Training
n=35 Participants
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
|
Waitlist Control
n=28 Participants
Will not receive active P-CPI training during the experimental treatment interval.
NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.
|
|---|---|---|
|
Change in the Parent Stress Index - Short Form Total Score
|
-2.7 units on a scale
Interval -6.3 to 0.8
|
-0.5 units on a scale
Interval -4.4 to 3.3
|
SECONDARY outcome
Timeframe: Baseline and 2-weeksPopulation: All 35 participants assigned to P-CPI training and 28 participants assigned to waitlist who completed the baseline assessment contributed at least one FQOL total score to the analysis. Four of these participants contributed only one score: two assigned to P-CPI training and one assigned to waitlist who discontinued study participation between baseline and two weeks, and one at baseline assigned to waitlist who provided incomplete FQOL data.
The FQOL is a 25-item measure assessing families' perceptions of their satisfaction with different aspects of family quality of life. It assesses five domains: family interaction, parenting, general resources, health and safety, and support for persons with disabilities. Instructions were modified to ask about the previous two weeks instead of the previous 12 months. The range of possible values for the FQOL total score is 25-125, with higher scores corresponding to better quality of life and positive change corresponding to improved quality of life. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.
Outcome measures
| Measure |
CPI-Parent Training
n=35 Participants
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI): Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
|
Waitlist Control
n=28 Participants
Will not receive active P-CPI training during the experimental treatment interval.
NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.
|
|---|---|---|
|
Change in the Family Quality of Life Scale Total Score
|
1.9 units on a scale
Interval -0.5 to 4.3
|
1.3 units on a scale
Interval -1.4 to 4.0
|
Adverse Events
CPI-Parent Training
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Nowinski, PhD
Massachusetts General Hospital Lurie Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place