Trial Outcomes & Findings for Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder (NCT NCT02995408)
NCT ID: NCT02995408
Last Updated: 2024-03-12
Results Overview
Visual Analogue Scale-Distress is a 1-item scale which asks responders to rate their level of distress on a scale of 0 to 10. A higher score indicates more distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
change between baseline (week 0) to post intervention (week 12)
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Experimental: 3RP Treatment
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
Experimental arm participated in the 8-week 3RP program starting immediately after enrollment.
|
Waitlist Control
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
The waitlist arm participated in the 8-week 3RP program starting 3 months after enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
Baseline characteristics by cohort
| Measure |
Experimental: 3RP Treatment
n=25 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
Waitlist Control
n=26 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
45 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
45 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change between baseline (week 0) to post intervention (week 12)Visual Analogue Scale-Distress is a 1-item scale which asks responders to rate their level of distress on a scale of 0 to 10. A higher score indicates more distress.
Outcome measures
| Measure |
Experimental: 3RP Treatment
n=20 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
Waitlist Control
n=22 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
|---|---|---|
|
Distress
|
-1.35 score on a scale
Standard Deviation 2.5
|
-.36 score on a scale
Standard Deviation 2.74
|
PRIMARY outcome
Timeframe: change between baseline (week 0) to post intervention (week 12)Current Experiences Scale is a 25-item measure of resilience adapted from the Post-Traumatic Growth Inventory to reflect current functioning in the domains of appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and an additional four items to assess current adaptive health behaviors. Total scores range from 0-25 and higher scores indicate greater resilience.
Outcome measures
| Measure |
Experimental: 3RP Treatment
n=20 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
Waitlist Control
n=22 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
|---|---|---|
|
Resiliency
|
6.05 score on a scale
Standard Deviation 8.04
|
.27 score on a scale
Standard Deviation 8.04
|
PRIMARY outcome
Timeframe: change between baseline (week 0) to post-intervention (week 12)Measure of Current Status (MOCS-A) is a 13-item self-report measure developed to assess perceived status on ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses. Total score range is 0 to 52, and higher scores indicate greater perceived proficiency with these skills.
Outcome measures
| Measure |
Experimental: 3RP Treatment
n=20 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
Waitlist Control
n=22 Participants
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Relaxation Response Resiliency Program for Parents of Children with ASD
|
|---|---|---|
|
Stress Reactivity/Coping
|
7.60 score on a scale
Standard Deviation 7.24
|
-.18 score on a scale
Standard Deviation 6.66
|
Adverse Events
Experimental: 3RP Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
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
Karen Kuhlthau, PhD Researcher
Massachusetts General Hospital
Phone: 6177242842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place