Clinical trial NCT03501914: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: Care givers
Adults
Intellectual Disability
Mindfulness
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mindfulness based intervention
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: sessions log
timeFrame: from start of intervention till end i.e., 12 Weeks
Secondary outcomes:
measure: Psychological Therapies Outcome Scale for Intellectual Disabilities (PTOS-ID)
timeFrame: Change in scores from Baseline to 12 Weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dar Ul Sakoon
Study officials:
References:
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.