Autism Spectrum DisorderVDTNCT06522490
Effects of Virtual Discrete Trial Training on Children With Autism Spectrum Disorder
A study testing Virtual discrete trial training in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder categorized by deficits in social communication and the occurrence of restricted interests and repetitive behaviors. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual discrete trial training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2023to 1 Feb 2024
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range between 3-10 years.
- Clinically diagnosed children from Psychologists were taken for study who had 2-3 words in vocabulary or no vocabulary at all.
- Each group received 3 weekly sessions for 45 minutes for 12 weeks.
- Video training was given through animated videos.
Who cannot join
- Children with any comorbidities e.g. Intellectual Disability, Cerebral Palsy, Attention Deficit Hyperactive Disorder, Down's Syndrome and Hearing Impaired children will exclude from this study.
- Children diagnosed with severe autism.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan society for rehabilitation of differently abled
Lahore, Punjab Province
About this study
Autism spectrum disorder (ASD) is a neurodevelopmental disorder categorized by deficits in social communication and the occurrence of restricted interests and repetitive behaviors. The cautionary needs of children with ASD are significant, it affects parents and siblings as well and requires substantial social support. If adequate intervention is not provided to children with ASD on time, then they may face many difficulties for example in academic work. They face social isolation and may develop additional challenging behaviors. Applied behavior analysis (ABA) is one of the most commonly used supported treatments for autism spectrum disorder. Discrete Trial Training (DTT) is one of the most structured Applied Behavior Analysis (ABA) types. DTT is the best standardized therapy for ASD. The ABA explores human interactions with their environment over time and develops interventional strategies to diminish the decline in the troublesomeness of social behavior among individuals with ASD. DTT through video training Program will be an effective in improving the communication skills of children with ASD. The video training program offers excellent accessibility and is inexpensive because it can be administered remotely and at home as well. It also reduces the resource barrios.
A randomized controlled study was conducted on children aged between 3-10 years diagnosed with ASD at PSRD hospital having Different severity levels. DTT was provided through a video training program using digital technology with informed consent from their caregivers/parents. The sample size was 10. Both groups contain 5 participants. The treatment group will be trained on DTT through the video training program. Sessions were conducted thrice a week for 45 minutes. The duration of the experiment was 12 weeks. The control group did not intervene with the video training program during the experiment. Pre \& Post language assessment was done through British Picture Vocabulary Scale.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual discrete trial training
- 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.
Virtual discrete trial trainingOther
Also called Face to face therapy
VDT was given to Experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Video Training was used for the experimental group Receives: Other: Virtual discrete trial training |
| Controlled group | Active comparator | Face to face therapy was used for the control group Receives: Other: Virtual discrete trial training |
What is being measured
The primary outcome is the main question the study is designed to answer.
British Picture Vocabulary Scale
It helps you identify any delay in vocabulary development, even before children are in full-time education. BPVS3 is a one-to-one test in a simple and easy to administer format. For each question, you say a word and the pupil responds by selecting a picture from four options that best illustrates that word's meaning
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start2 Nov 2023
- Primary completion5 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahzadi Arshad, MS SLP, Principal investigator, Pakistan Society for Rehabilitation of differently abled
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522490
- Sponsor's protocol ID
- RiphahIU-123 Shahzadi Arshad
- Acronym
- VDT
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Discrete Trial Training on Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06522490
- Acronym / sponsor ID
- VDT / RiphahIU-123 Shahzadi Arshad
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- 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.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder categorized by deficits in social communication and the occurrence of restricted interests and repetitive behaviors. The cautionary needs of children with ASD are significant, it affects parents and siblings as well and requires substantial social support. If adequate intervention is not provided to children with ASD on time, then they may face many difficulties for example in academic work. They face social isolation and may develop additional challenging behaviors. Applied behavior analysis (ABA) is one of the most commonly used supported treatments for autism spectrum disorder. Discrete Trial Training (DTT) is one of the most structured Applied Behavior Analysis (ABA) types. DTT is the best standardized therapy for ASD. The ABA explores human interactions with their environment over time and develops interventional strategies to diminish the decline in the troublesomeness of social behavior among individuals with ASD. DTT through video training Program will be an effective in improving the communication skills of children with ASD. The video training program offers excellent accessibility and is inexpensive because it can be administered remotely and at home as well. It also reduces the resource barrios.
A randomized controlled study was conducted on children aged between 3-10 years diagnosed with ASD at PSRD hospital having Different severity levels. DTT was provided through a video training program using digital technology with informed consent from their caregivers/parents. The sample size was 10. Both groups contain 5 participants. The treatment group will be trained on DTT through the video training program. Sessions were conducted thrice a week for 45 minutes. The duration of the experiment was 12 weeks. The control group did not intervene with the video training program during the experiment. Pre \& Post language assessment was done through British Picture Vocabulary Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Virtual discrete trial trainingVideo Training was used for the experimental group |
| Controlled group | Active comparator | Other: Virtual discrete trial trainingFace to face therapy was used for the control group |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age range between 3-10 years.
- Clinically diagnosed children from Psychologists were taken for study who had 2-3 words in vocabulary or no vocabulary at all.
- Each group received 3 weekly sessions for 45 minutes for 12 weeks.
- Video training was given through animated videos.
Key exclusion criteria (2 listed)
- Children with any comorbidities e.g. Intellectual Disability, Cerebral Palsy, Attention Deficit Hyperactive Disorder, Down's Syndrome and Hearing Impaired children will exclude from this study.
- Children diagnosed with severe autism.
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 |
|---|---|---|
| Virtual discrete trial trainingAlso: Face to face therapyVDT was given to Experimental group. | Other | Controlled group, Experimental group |
Primary outcome
British Picture Vocabulary Scale
Time frame: 3 months
It helps you identify any delay in vocabulary development, even before children are in full-time education. BPVS3 is a one-to-one test in a simple and easy to administer format. For each question, you say a word and the pupil responds by selecting a picture from four options that best illustrates that word's meaning
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 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Shahzadi Arshad, MS SLP principal investigator
Pakistan Society for Rehabilitation of differently abled
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual discrete trial training in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 2 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 26 Jul 2024. 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 Pakistan. 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?
British Picture Vocabulary Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2024.