- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02384486
Efficacy of Training Programme to Reduce Stress
May 16, 2016 updated by: University of Nottingham
Evaluating the Efficacy of a Proposed Training Programme to Reduce Stress in Mothers of Children With Autism Spectrum Disorder (ASD) in Saudi Arabia: A Pilot Study
This study aims to reduce stress in mothers of children with autism in Saudi Arabia.
The researcher has designed a training programme for mothers whose children are young and just in their early stage at the autism organisations they are attending.
The programme will include stress reduction tips, behavioural modification strategies for children with autism, and financial resources available to parents (how they can access government funding).
The study will have two parts.
Part one involves conducting an experiment by dividing the participants into two groups, one group will receive the training and the other group will wait until the end of the study then they will also receive the same training.
Both groups will fill questionnaire at the beginning of the study, then after the first group finishes training, and then again 6 weeks later.
Part two of the study will involve interviewing mothers of the first group who attended the training session.
They will be interviewed by the researcher asking them about their experience with the training programme and their suggestions for future improvements.
Mothers will be given a training manual at the beginning of the training.
Training involves attending five sessions, one of which is a face to face session at the autism organisation their children are attending and the other four sessions will be through a Smartphone application called whatsapp which is widely used in Saudi Arabia.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jeddah, Saudi Arabia
- Voluntary sector ASD organization no.1
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers aged 18 years or over
- mothers of ASD children who are in the early intervention stage (first year in the programme) at autism organizations in Saudi Arabia
Exclusion Criteria:
Mothers whose children with ASD are not in the early intervention stage or did not joint autism organization
- Mothers who will not be willing to commence to the full duration of the trial
- Mothers who will not be able to use whatsapp in their smart phones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
intervention group will receive the "Training to Reduce Stress in Mothers of Children with (ASD)"
|
The main objective of the proposed study is to examine the effect of implementing the proposed intervention on stress in mothers of children with ASD in SA
|
Other: control group
control group will receive nothing but for ethical purposes will receive the same intervention after the end of the trial for the intervention group
|
Mothers in the control group will continue to receive treatment as usual during the trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parent Stress Index Short From (PSI-SF)
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 4, 2015
First Submitted That Met QC Criteria
March 4, 2015
First Posted (Estimate)
March 10, 2015
Study Record Updates
Last Update Posted (Estimate)
May 17, 2016
Last Update Submitted That Met QC Criteria
May 16, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OVS12022015 SA SoM PAPsych PhD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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