NCT02772432

Brief Summary

This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with special needs, this study aims to identify the psychosocial needs of parents of children with learning disabilities, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP). Phase II: Informed by Phase I findings, this study aims to develop and determine the feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP) program for parents of children with Specific Learning Disabilities (SPLD). Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial, establishing efficacy of a virtual resiliency program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

May 12, 2016

Results QC Date

May 25, 2019

Last Update Submit

September 9, 2019

Conditions

Keywords

resiliency trainingparentingspecial learning disability

Outcome Measures

Primary Outcomes (2)

  • Distress

    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.

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

  • Current Experiences Scale

    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.

    Change between baseline and 12-weeks

Secondary Outcomes (1)

  • Stress Reactivity

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

Study Arms (2)

3RP treatment

EXPERIMENTAL

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.

Behavioral: Relaxation Response Resiliency Training for Parents of SPLD

Waitlist control

ACTIVE COMPARATOR

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

Behavioral: Relaxation Response Resiliency Training for Parents of SPLD

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being the parent of at least one elementary school aged child with a diagnosed specific learning disability
  • Age 18 or older

You may not qualify if:

  • Being the parent of a child with a severe mental or physical disability up to the discretion of the principal investigator
  • Unable or unwilling to sign the informed consent documents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02141, United States

Location

Related Publications (1)

  • Park ER, Perez GK, Millstein RA, Luberto CM, Traeger L, Proszynski J, Chad-Friedman E, Kuhlthau KA. A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial. Matern Child Health J. 2020 Jan;24(1):39-53. doi: 10.1007/s10995-019-02815-3.

Results Point of Contact

Title
Elyse Park
Organization
Mass General Hospital

Study Officials

  • Elyse Park, PhD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are assigned to the immediate or wait-list control intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Psychiatry (HMS)

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 13, 2016

Study Start

September 1, 2016

Primary Completion

May 18, 2018

Study Completion

May 18, 2018

Last Updated

September 10, 2019

Results First Posted

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations