NCT02384486

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

March 4, 2015

Last Update Submit

May 16, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Parent Stress Index Short From (PSI-SF)

    10 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

intervention group will receive the "Training to Reduce Stress in Mothers of Children with (ASD)"

Behavioral: Training to Reduce Stress in Mothers of Children with (ASD)

control group

OTHER

control group will receive nothing but for ethical purposes will receive the same intervention after the end of the trial for the intervention group

Other: Nothing (treatment as usual)

Interventions

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

intervention group

Mothers in the control group will continue to receive treatment as usual during the trial

control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Voluntary sector ASD organization no.1

Jeddah, Saudi Arabia

Location

Related Publications (1)

  • Hemdi A, Daley D. The Effectiveness of a Psychoeducation Intervention delivered via WhatsApp for mothers of children with Autism Spectrum Disorder (ASD) in the Kingdom of Saudi Arabia: A randomized controlled trial. Child Care Health Dev. 2017 Nov;43(6):933-941. doi: 10.1111/cch.12520. Epub 2017 Sep 20.

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 10, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations