Efficacy of Training Programme to Reduce Stress

Autism Spectrum Disorder (ASD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384486
• Other study ID #: OVS12022015 SA SoM PAPsych PhD
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: May 16, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: King Abdulaziz University
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• 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:
• Nothing (treatment as usual)
Mothers in the control group will continue to receive treatment as usual during the trial

Locations

Country	Name	City	State
Saudi Arabia	Voluntary sector ASD organization no.1	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Stress Index Short From (PSI-SF)		10 weeks	No