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Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities (SPLD)

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ClinicalTrials.gov Identifier: NCT02772432
Recruitment Status : Completed
First Posted : May 13, 2016
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Marino Foundation
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stress
Intervention Behavioral: Relaxation Response Resiliency Training for Parents of SPLD
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3RP Treatment Waitlist Control
Hide Arm/Group Description

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Relaxation Response Resiliency Training for Parents of SPLD

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Relaxation Response Resiliency Training for Parents of SPLD

Period Title: Overall Study
Started 31 22
Completed 19 21
Not Completed 12 1
Arm/Group Title 3RP Treatment Waitlist Control Total
Hide Arm/Group Description

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Relaxation Response Resiliency Training for Parents of SPLD

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Relaxation Response Resiliency Training for Parents of SPLD

Total of all reporting groups
Overall Number of Baseline Participants 31 22 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 22 participants 53 participants
47  (6.2) 47  (4.9) 47  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 22 participants 53 participants
Female
26
  83.9%
22
 100.0%
48
  90.6%
Male
5
  16.1%
0
   0.0%
5
   9.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 22 participants 53 participants
Hispanic or Latino
1
   3.2%
1
   4.5%
2
   3.8%
Not Hispanic or Latino
30
  96.8%
21
  95.5%
51
  96.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 22 participants 53 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.2%
1
   4.5%
2
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.2%
1
   4.5%
2
   3.8%
White
28
  90.3%
20
  90.9%
48
  90.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.2%
0
   0.0%
1
   1.9%
1.Primary Outcome
Title Distress
Hide Description The Visual Analog Scale (VAS)-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.
Time Frame change between baseline (week 0) to 12 weeks post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3RP Treatment Waitlist Control
Hide Arm/Group Description:

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Relaxation Response Resiliency Training for Parents of SPLD

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Relaxation Response Resiliency Training for Parents of SPLD

Overall Number of Participants Analyzed 31 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.47  (2.44) .48  (2.33)
2.Primary Outcome
Title Current Experiences Scale
Hide Description The CES is a 25-item measure of resilience adapted from the Post-Traumatic Growth Inventory (PTGI) to reflect current functioning in the domains of appreciation for life (AL), adaptive perspectives (AP), personal strength (PS), spiritual connectedness (SC), relating to others (RO), and an additional four items to assess current adaptive health behaviors (HB) that are not part of the PTGI. The CES is scored on a scale from 0-125 with higher scores indicating greater resilience.
Time Frame Change between baseline and 12-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3RP Treatment Waitlist Control
Hide Arm/Group Description:

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Relaxation Response Resiliency Training for Parents of SPLD

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Relaxation Response Resiliency Training for Parents of SPLD

Overall Number of Participants Analyzed 31 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.67  (7.33) 1.29  (8.03)
3.Secondary Outcome
Title Stress Reactivity
Hide Description The Measure of Current Status Part A (MOCS-A) is a 13-item self-report measure developed to assess participants' current self-perceived status on several skills: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Scores can range from 0 to 52, and higher scores are correlated with greater self- perceived proficiency with these skills.
Time Frame change between baseline (week 0) to 12 weeks post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3RP Treatment Waitlist Control
Hide Arm/Group Description:

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Relaxation Response Resiliency Training for Parents of SPLD

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Relaxation Response Resiliency Training for Parents of SPLD

Overall Number of Participants Analyzed 31 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.74  (7.59) -.95  (4.57)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3RP Treatment Waitlist Control
Hide Arm/Group Description

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Relaxation Response Resiliency Training for Parents of SPLD

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Relaxation Response Resiliency Training for Parents of SPLD

All-Cause Mortality
3RP Treatment Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
3RP Treatment Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3RP Treatment Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elyse Park
Organization: Mass General Hospital
Phone: 6177246836
EMail: epark@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Elyse Park, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02772432    
Other Study ID Numbers: 2016P000423
First Submitted: May 12, 2016
First Posted: May 13, 2016
Results First Submitted: May 25, 2019
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019