Trial Outcomes & Findings for Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities (NCT NCT02772432)

Last Updated: 2019-09-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

change between baseline (week 0) to 12 weeks post intervention

Results posted on

2019-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	3RP Treatment 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	Waitlist Control 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 Study STARTED	31	22
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	12	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3RP Treatment n=31 Participants 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	Waitlist Control n=22 Participants 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 n=53 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 6.2 • n=93 Participants	47 years STANDARD_DEVIATION 4.9 • n=4 Participants	47 years STANDARD_DEVIATION 5.7 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	22 Participants n=4 Participants	48 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=93 Participants	21 Participants n=4 Participants	51 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	20 Participants n=4 Participants	48 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: change between baseline (week 0) to 12 weeks post intervention

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.

Outcome measures

Outcome measures
Measure	3RP Treatment n=31 Participants 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	Waitlist Control n=22 Participants 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
Distress	-1.47 score on a scale Standard Deviation 2.44	.48 score on a scale Standard Deviation 2.33

PRIMARY outcome

Timeframe: Change between baseline and 12-weeks

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.

Outcome measures

Outcome measures
Measure	3RP Treatment n=31 Participants 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	Waitlist Control n=22 Participants 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
Current Experiences Scale	7.67 score on a scale Standard Deviation 7.33	1.29 score on a scale Standard Deviation 8.03

SECONDARY outcome

Timeframe: change between baseline (week 0) to 12 weeks post intervention

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.

Outcome measures

Outcome measures
Measure	3RP Treatment n=31 Participants 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	Waitlist Control n=22 Participants 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
Stress Reactivity	7.74 score on a scale Standard Deviation 7.59	-.95 score on a scale Standard Deviation 4.57

Adverse Events

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

Elyse Park

Mass General Hospital

Phone: 6177246836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place