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A Pilot Trial of Mindfulness Based Intervention Program for People With Intellectual Disabilities in a Low Income Setting

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability focused on measuring Care givers, Adults, Intellectual Disability, Mindfulness

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years and above
  • Able to cope with 90 minute session (with 10 minute break)
  • Able to be in a group setting
  • Able to get to the location of the group
  • Able to attend most sessions
  • All abilities welcome (including individuals who may struggle with language comprehension/expression)
  • Able to attend with a consistent staff member/carer for all sessions.

Exclusion Criteria:

  • Unable to cope with 90 minute session (with 10 minute break)
  • Person struggles with proximity of others or bring in a group setting
  • If physically unwell (new onset of severe illness)
  • Inconsistent staff team/carers supporting person to sessions
  • Ongoing experience of trauma or symptoms of Post-Traumatic Stress Disorder

Sites / Locations

  • Dar Ul Sakoon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Based Intervention

Arm Description

Mindfulness principles based manualized intervention will be provided to the participants which is developed by colleagues in Manchester. This intervention will be adapted to be accessible for people having intellectual disability (ID) in Pakistan.Sessions will take place once-weekly for 12 weeks including an initial orientation session. It will include breathing, soles of the feet, body scan, guided meditation, mindful stretching and walking

Outcomes

Primary Outcome Measures

sessions log
We aim to determine whether the mindfulness intervention would be feasible to deliver and acceptable to the participants measured through sessions log

Secondary Outcome Measures

Psychological Therapies Outcome Scale for Intellectual Disabilities (PTOS-ID)
PTOS-D will be used to assess psychological distress and positive well being of the participants and caregivers. it is a 29 item scale with 16 questions (Measuring Psychological Distress: higher score indicates higher psychological distress) and 11 questions measuring positive well-being: higher scores indicates higher positive well-being. The other two questions: Q-12 and Q-13 does not contribute to the indexes.

Full Information

First Posted
April 5, 2018
Last Updated
March 19, 2019
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT03501914
Brief Title
A Pilot Trial of Mindfulness Based Intervention Program for People With Intellectual Disabilities in a Low Income Setting
Official Title
Mindfulness Based Intervention for Individuals With Intellectual Disabilities and Their Care Givers: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed study is a pre-post intervention study to investigate the acceptability and feasibility of a mindfulness based program for people with intellectual disabilities and their caregivers in a low income setting in Pakistan.
Detailed Description
In Pakistan, prevalence of intellectual disability is 19.1/1000 severe intellectual disability and 65/1000 for mild level of intellectual disability. Disability not only affects the individual but also the family in general and caretaker specifically. Several researches proved that parents of children with disabilities experience number of problems related to parenting stress. There is a dire need to develop feasible, cost-effective, community level interventions, that would augment existing healthcare systems. Mindfulness as a relatively new therapeutic strategy, has not been practiced as far as individuals with intellectual disability are concerned. This study aims to explore the feasibility and acceptability of mindfulness-based strategies for individuals with intellectual disability and their care takers in improving their well-being. A sample of 12 participants will be recruited from rehabilitation centers. The study will be conducted in Karachi. The group intervention will consist of twelve sessions; approx. 90-minutes per session weekly. therapy logswill be used to measure feasibility and acceptability of the intervention and the full Psychological Therapies Outcome Scale - intellectual disabilities (PTOS)-ID (psychological distress and positive well-being scales) will be used as secondary outcome measure. In addition, the positive well-being section of the PTOS-ID will also be administered at session 3 and 6 as an interim measure of well-being. Baseline assessment will be done following the consent. Post assessments will be conducted at the end of intervention (at 3 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
Care givers, Adults, Intellectual Disability, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mindfulness based intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Intervention
Arm Type
Experimental
Arm Description
Mindfulness principles based manualized intervention will be provided to the participants which is developed by colleagues in Manchester. This intervention will be adapted to be accessible for people having intellectual disability (ID) in Pakistan.Sessions will take place once-weekly for 12 weeks including an initial orientation session. It will include breathing, soles of the feet, body scan, guided meditation, mindful stretching and walking
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
A mindfulness program based on mindfulness-based principles developed by colleagues in Manchester will be adapted to be accessible for people with intellectual disabilities (ID) in Pakistan. This intervention will be translated into Urdu afterwards focus group will be conducted to get the views from people with ID, thei care takers and other stake holders to adapt and culturally modify the program. It will include some mindfulness based exercises i.e.welcome & introduction, exploring senses, its all in the mind, Mindful eating, breathing, soles of the feet, body scan, guided meditation, mindful stretching and walking.
Primary Outcome Measure Information:
Title
sessions log
Description
We aim to determine whether the mindfulness intervention would be feasible to deliver and acceptable to the participants measured through sessions log
Time Frame
from start of intervention till end i.e., 12 Weeks
Secondary Outcome Measure Information:
Title
Psychological Therapies Outcome Scale for Intellectual Disabilities (PTOS-ID)
Description
PTOS-D will be used to assess psychological distress and positive well being of the participants and caregivers. it is a 29 item scale with 16 questions (Measuring Psychological Distress: higher score indicates higher psychological distress) and 11 questions measuring positive well-being: higher scores indicates higher positive well-being. The other two questions: Q-12 and Q-13 does not contribute to the indexes.
Time Frame
Change in scores from Baseline to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and above Able to cope with 90 minute session (with 10 minute break) Able to be in a group setting Able to get to the location of the group Able to attend most sessions All abilities welcome (including individuals who may struggle with language comprehension/expression) Able to attend with a consistent staff member/carer for all sessions. Exclusion Criteria: Unable to cope with 90 minute session (with 10 minute break) Person struggles with proximity of others or bring in a group setting If physically unwell (new onset of severe illness) Inconsistent staff team/carers supporting person to sessions Ongoing experience of trauma or symptoms of Post-Traumatic Stress Disorder
Facility Information:
Facility Name
Dar Ul Sakoon
City
Karachi
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Citations:
Citation
Chapman, M.J., Hare, D.J., Caton, S., Donalds, D., McInnis, E., & Mitchell, D. (2013). The use of mindfulness with people with intellectual disability: A systematic review and narrative analysis. Mindfulness, 4. Doi: 10.1007/s12671-013-0197-7.
Results Reference
background

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A Pilot Trial of Mindfulness Based Intervention Program for People With Intellectual Disabilities in a Low Income Setting

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