Autism Spectrum Disorder (ASD)NCT02384486
Efficacy of Training Programme to Reduce Stress
A study testing Training to Reduce Stress in Mothers of Children with (ASD) and Nothing (treatment as usual) in people with Autism Spectrum Disorder (ASD), run by University of Nottingham at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Training to Reduce Stress in Mothers of Children with (ASD) and Nothing (treatment as usual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Training to Reduce Stress in Mothers of Children with (ASD), Nothing (treatment as usual)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training to Reduce Stress in Mothers of Children with (ASD)Behavioural
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
Nothing (treatment as usual)Other
Mothers in the control group will continue to receive treatment as usual during the trial
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | intervention group will receive the "Training to Reduce Stress in Mothers of Children with (ASD)" Receives: 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 Receives: Other: Nothing (treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Stress Index Short From (PSI-SF)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384486
- Sponsor's protocol ID
- OVS12022015 SA SoM PAPsych PhD
- Status last verified
- May 2016
- First submitted
- 4 Mar 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28929582
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02384486
- Acronym / sponsor ID
- OVS12022015 SA SoM PAPsych PhD
- Conditions
- Autism Spectrum Disorder (ASD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Training to Reduce Stress in Mothers of Children with (ASD)intervention group will receive the "Training to Reduce Stress in Mothers of Children with (ASD)" |
| control group | Other | Other: Nothing (treatment as usual)control group will receive nothing but for ethical purposes will receive the same intervention after the end of the trial for the intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Mothers whose children with ASD are not in the early intervention stage or did not joint autism organization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | intervention group |
| Nothing (treatment as usual)Mothers in the control group will continue to receive treatment as usual during the trial | Other | control group |
Primary outcome
Parent Stress Index Short From (PSI-SF)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 28929582Hemdi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training to Reduce Stress in Mothers of Children with (ASD) and Nothing (treatment as usual) in people with Autism Spectrum Disorder (ASD), run by University of Nottingham at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Stress Index Short From (PSI-SF) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.