Autism Spectrum DisorderASDNCT05829577
Integrated Life Skill Training and Executive Function Strategies in Children With ASD
A study testing Executive Function Strategies and Training, Daily Life skill training and Sensory Integration /Processing training in people with Autism Spectrum Disorder, run by Hamad General Hospital at 1 site in Qatar.
Trial summary
The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Executive Function Strategies and Training, Daily Life skill training and Sensory Integration /Processing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteQatar
- Study dates
- 1 Feb 2023to 30 Dec 2023
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who were diagnosed with ASD
- Those who were referred to Autism Program
- Those aged 3-5 years (Diamond, 2013)
- Patients first admitted to Autism Individual therapy program .
- All children with different language will be included and if parents couldn't complete some of the required outcome measure, they will be excluded on the analysis stage of study
Who cannot join
- Patients who have severe Impairment learning and linguistic acquisition skill based on VB-MAPP (has score 4 on any item of Barrier Assessment)
- Those who did not provide consent for the study
- Elimination criteria
- Children who do not complete 13 intervention sessions following the research protocol .
- Children who received other interventions that may affect the study results .
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, Qatar -doha
INSTITUTIONAL REVIEW BOARD HAMAD MEDICAL CORPORATION, 0097433521137 ext. 4025, irb@hamad.qa
About this study
Official title: The Effectiveness of Using Daily Living Skills and Sensory Integration Training Combined With Executive Function Strategies for Improving Self-Care, Sensory Integration and Fine Motor Skills in Children With ASD in Qatar: A Randomized Control Trial
The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum Disorder , the study will compare between applying regular occupational therapy alone and applying regular occupational therapy plus executive function strategies in improving children with autism spectrum disorder , they will be two group in the study: first group called control group and second group called intervention group, if child is assign on control group he/she will receive regular individual occupational therapy services in autism program which is :Sensory integration which might include things like playing with different interactive games, different textures swinging, bouncing or climbing , and children will also receive life skill training which target training child on self-care skill like grooming, feeding, dressing undressing and toiling skills ) And (if the child assigned on intervention group he/she will receive also regular individual occupational therapy services which described above plus getting executive function training which will be implemented during training the child on daily life skill and this might include using timer during the training, organized schedules, special motivation system and others ,before enrolling children on treatment or control group parent will be asked to sign consent form and after that children will screened based on specific criteria make sure that they are fit for the study then if they meet the study criteria they will also "randomized" into one of two study groups ,Randomization means that putting child into a group by chance. It is like flipping a coin and each child will have a 50% chance of being place in a specific group, following that children will be have detailed assessments which will be done by an experienced occupational therapist and these assessment is aiming to measure the improvement on children condition after receiving therapy ,and will done before treatment , after seven weeks of treatment and completion program at 14 week then data from assessment will be analyzed, each group will receive forty five min regular weekly individual therapy sessions and this extent for thirteen weeks .
Read the detailed description
The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum Disorder , the study will compare between applying regular occupational therapy alone and applying regular occupational therapy plus executive function strategies in improving children with autism spectrum disorder , regular occupational therapy consist of 1. Sensory integration and sensory processing Training which target reduction of sensory problem those children might like : sensitivity to sound or lights, selective and picky eating, hypersensitivity to touch and different texture, avoidant of some body movement or hyperactivity, 2.Dailiy life skills Training : like training children on grooming skills, dressing and undressing and toilet training ,and the main question which aim to answer : Is the use of Executive strategies combined with training Sensory integration / sensory processing and daily life skills training more effective than Sensory integration and daily life skill training alone in improving children with Autism Spectrum Disorder ? they will be 2 group in the study: first group called control group and second group called intervention group, if child is assign on control group he/she will receive regular individual occupational therapy services in autism program which is :Sensory integration therapy which involve activities to stimulate sensory responses from the child ,this might include things like playing with different interactive games, different textures swinging, bouncing or climbing , and child will also receive life skill training which target training child on self-care skill like grooming, feeding, dressing undressing and toiling skills ) And (if the child assigned on intervention group he/she will receive also regular individual occupational therapy services which described above plus getting executive function training which will be implemented during training the child on daily life skill and this might include using timer during the training, organized schedules, special motivation system and others which will be explained in more details by therapist before commencing with treatment .
before enrolling children on treatment or control group parent will be asked to sign consent form and after that children will screened based on specific criteria make sure that they are fit for the study then if they meet the study criteria they will also "randomized" into one of two study groups ,Randomization means that you are put into a group by chance. It is like flipping a coin and each child will have a 50% chance of being place in a specific group, following that children will be have detailed assessments which will be done by an experienced occupational therapist and these assessment is aiming to measure the improvement on child condition after receiving therapy ,and will done before treatment and after seven weeks of treatment and after completion of treatment and after completion all dat from these assessments will analyzed , each group will receive forty five min regular weekly individual therapy sessions and this extent for thirteen weeks .
Primacy outcome measure will be :
- Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) will be used for determining the inclusion criteria and measuring improvement on self help skills,
- Pediatric Functional Independent Measure (WeeFIM): will be used to measure improvement in self-care and social cognition skills,
- Short Sensory Profile™ 2 (SSP2) will be used to measure improvement in sensory processing , Sp2 comprise 34-item caregiver questionnaire
Secondary Outcome measure will be :
Visual Motor Integration Test (Beery-VMI) will be used to monitor changes in visual motor integration skills as part of fine motor skills Primary outcome of the study will be measured based on (VB-MAPP,SP2,VMI,WeeFIM) Changes in the pretest-and posttest scores(Standard Score, Percentile Rank, P value) will be compared between the intervention and control groups using a Linear-mixed regression model and analysis of covariance (ANCOVA)Using repeated-measures analysis of variance, with comparing baseline scores with reassessment and poste treatment scores.
To analyze the data, Statistical Package for Social Science (SPSS-28) software will be used.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Executive Function Strategies and Training, Daily Life skill training, Sensory Integration /Processing training
- Keywords
- ASD
- 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.
Executive Function Strategies and TrainingOther
will be conducted by primary investigator and trained therapist ,EF strategies will be implemented during DLS and SI training and these strategies will target following area which proved by evidences within the context of functional training: Using monitoring system for each child , Improving sense of time, Externalize important information , Externalize Motivation, Provide consequences: Immediately, more frequently, Higher magnitude and more powerful, Richer degree of incentive, Rotated or changed more frequently, Personalize the command, praise, instruction, reprimanding, Process training, remediation and training on executive function skill
Daily Life skill trainingOther
each child will receive 25 minute of DLS training which will focus on training children on Grooming, feeding, dressing undressing, toileting and community reintegration tasks aligned with facilitation fine motor skills for children and Using several techniques for ADL training including : prompting, shaping, forward and backward chaining, and modeling ,training children based on level of independency identified by WeeFIM score
Sensory Integration /Processing trainingOther
each patient will receive 20 min of SI/SP training Manualized SI/SP intervention which will be used is based on the principles of sensory integration as outlined by Ayres ,such as deep pressure, brushing, weighted vests, and swinging will used , individually-tailored treatment activities might include activities such as using a carpeted scooter board while in the prone position to pull oneself up a ramp, then working to turn the scooter board around to ride down the ramp and land in a cushioned area of mats and pillows that are covered with various textures. Intervention is contextualized in play with active involvement of the child will be conducted in a large gym equipped with mats, a variety of suspended swings, large balls, a climbing wall, carpeted barrels, large inner tubes and foam blocks with opportunities for active, guided, sensory motor play.
| Study group | Role | What they receive |
|---|---|---|
| Executive function treatment | Experimental | Patient will receive Individual DLS and SI/SP training combined with EF strategies Receives: Other: Executive Function Strategies and Training; Other: Daily Life skill training; Other: Sensory Integration /Processing training |
| Treatment as usual | Active comparator | patient will receive Individual DLS and SI/SP training. Receives: Other: Daily Life skill training; Other: Sensory Integration /Processing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
will be used for determining if participant is eligible for study and measuring change on self help skills.
Measured: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Pediatric Functional Independent Measure (WeeFIM)
will be used to measure changes in self-care and social cognition skills .
Measured: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Short Sensory Profile™ 2 (SSP2)
will be used to measure improvement in sensory processing skills .
Measured: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Secondary outcomes (1)
Visual Motor Integration Test (Beery-VMI)
will be used to monitor changes in visual motor integration skills as part of fine motor skills
Measured: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Feb 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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.
- 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
- Model description
- Single blind one center randomized control trial (RCT) with one arm :control group will receive Individual Sensory integration / sensory processing and daily life skills training , treatment group will receive Individual Sensory integration / sensory processing and daily life skills training training combined with EF strategies both groups will receive 1 session individual OT/week for 45 min for 14 weeks .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad General Hospital
- Sponsor type
- Other government
- Collaborators
- Universiti Sultan Zainal Abidin
- Responsible party
- Principal investigator, Bara Yousef, Hamad General Hospital
- Investigators
- BARA M YOUSEF, Bsc, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829577
- Sponsor's protocol ID
- MRC-01-22-509
- Acronym
- ASD
- Status last verified
- May 2023
- First submitted
- 1 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using Daily Living Skills and Sensory Integration Training Combined With Executive Function Strategies for Improving Self-Care, Sensory Integration and Fine Motor Skills in Children With ASD in Qatar: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05829577
- Acronym / sponsor ID
- ASD / MRC-01-22-509
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hamad General HospitalOther government
- Collaborators
- Universiti Sultan Zainal Abidin
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum Disorder , the study will compare between applying regular occupational therapy alone and applying regular occupational therapy plus executive function strategies in improving children with autism spectrum disorder , they will be two group in the study: first group called control group and second group called intervention group, if child is assign on control group he/she will receive regular individual occupational therapy services in autism program which is :Sensory integration which might include things like playing with different interactive games, different textures swinging, bouncing or climbing , and children will also receive life skill training which target training child on self-care skill like grooming, feeding, dressing undressing and toiling skills ) And (if the child assigned on intervention group he/she will receive also regular individual occupational therapy services which described above plus getting executive function training which will be implemented during training the child on daily life skill and this might include using timer during the training, organized schedules, special motivation system and others ,before enrolling children on treatment or control group parent will be asked to sign consent form and after that children will screened based on specific criteria make sure that they are fit for the study then if they meet the study criteria they will also "randomized" into one of two study groups ,Randomization means that putting child into a group by chance. It is like flipping a coin and each child will have a 50% chance of being place in a specific group, following that children will be have detailed assessments which will be done by an experienced occupational therapist and these assessment is aiming to measure the improvement on children condition after receiving therapy ,and will done before treatment , after seven weeks of treatment and completion program at 14 week then data from assessment will be analyzed, each group will receive forty five min regular weekly individual therapy sessions and this extent for thirteen weeks .
Detailed description
The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum Disorder , the study will compare between applying regular occupational therapy alone and applying regular occupational therapy plus executive function strategies in improving children with autism spectrum disorder , regular occupational therapy consist of 1. Sensory integration and sensory processing Training which target reduction of sensory problem those children might like : sensitivity to sound or lights, selective and picky eating, hypersensitivity to touch and different texture, avoidant of some body movement or hyperactivity, 2.Dailiy life skills Training : like training children on grooming skills, dressing and undressing and toilet training ,and the main question which aim to answer : Is the use of Executive strategies combined with training Sensory integration / sensory processing and daily life skills training more effective than Sensory integration and daily life skill training alone in improving children with Autism Spectrum Disorder ? they will be 2 group in the study: first group called control group and second group called intervention group, if child is assign on control group he/she will receive regular individual occupational therapy services in autism program which is :Sensory integration therapy which involve activities to stimulate sensory responses from the child ,this might include things like playing with different interactive games, different textures swinging, bouncing or climbing , and child will also receive life skill training which target training child on self-care skill like grooming, feeding, dressing undressing and toiling skills ) And (if the child assigned on intervention group he/she will receive also regular individual occupational therapy services which described above plus getting executive function training which will be implemented during training the child on daily life skill and this might include using timer during the training, organized schedules, special motivation system and others which will be explained in more details by therapist before commencing with treatment .
before enrolling children on treatment or control group parent will be asked to sign consent form and after that children will screened based on specific criteria make sure that they are fit for the study then if they meet the study criteria they will also "randomized" into one of two study groups ,Randomization means that you are put into a group by chance. It is like flipping a coin and each child will have a 50% chance of being place in a specific group, following that children will be have detailed assessments which will be done by an experienced occupational therapist and these assessment is aiming to measure the improvement on child condition after receiving therapy ,and will done before treatment and after seven weeks of treatment and after completion of treatment and after completion all dat from these assessments will analyzed , each group will receive forty five min regular weekly individual therapy sessions and this extent for thirteen weeks .
Primacy outcome measure will be :
- Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) will be used for determining the inclusion criteria and measuring improvement on self help skills,
- Pediatric Functional Independent Measure (WeeFIM): will be used to measure improvement in self-care and social cognition skills,
- Short Sensory Profile™ 2 (SSP2) will be used to measure improvement in sensory processing , Sp2 comprise 34-item caregiver questionnaire
Secondary Outcome measure will be :
Visual Motor Integration Test (Beery-VMI) will be used to monitor changes in visual motor integration skills as part of fine motor skills Primary outcome of the study will be measured based on (VB-MAPP,SP2,VMI,WeeFIM) Changes in the pretest-and posttest scores(Standard Score, Percentile Rank, P value) will be compared between the intervention and control groups using a Linear-mixed regression model and analysis of covariance (ANCOVA)Using repeated-measures analysis of variance, with comparing baseline scores with reassessment and poste treatment scores.
To analyze the data, Statistical Package for Social Science (SPSS-28) software will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind one center randomized control trial (RCT) with one arm :control group will receive Individual Sensory integration / sensory processing and daily life skills training , treatment group will receive Individual Sensory integration / sensory processing and daily life skills training training combined with EF strategies both groups will receive 1 session individual OT/week for 45 min for 14 weeks .
| Arm | Type | Receives |
|---|---|---|
| Executive function treatment | Experimental | Other: Executive Function Strategies and Training, Other: Daily Life skill training, Other: Sensory Integration /Processing trainingPatient will receive Individual DLS and SI/SP training combined with EF strategies |
| Treatment as usual | Active comparator | Other: Daily Life skill training, Other: Sensory Integration /Processing trainingpatient will receive Individual DLS and SI/SP training. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients who were diagnosed with ASD
- Those who were referred to Autism Program
- Those aged 3-5 years (Diamond, 2013)
- Patients first admitted to Autism Individual therapy program .
- All children with different language will be included and if parents couldn't complete some of the required outcome measure, they will be excluded on the analysis stage of study
Key exclusion criteria (5 listed)
- Patients who have severe Impairment learning and linguistic acquisition skill based on VB-MAPP (has score 4 on any item of Barrier Assessment)
- Those who did not provide consent for the study
- Elimination criteria
- Children who do not complete 13 intervention sessions following the research protocol .
- Children who received other interventions that may affect the study results .
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 |
|---|---|---|
| Executive Function Strategies and Trainingwill be conducted by primary investigator and trained therapist ,EF strategies will be implemented during DLS and SI training and these strategies will target following area which proved by evidences within the context of functional training: Using monitoring system for each child , Improving sense of time, Externalize important information , Externalize Motivation, Provide consequences: Immediately, more frequently, Higher magnitude and more powerful, Richer degree of incentive, Rotated or changed more frequently, Personalize the command, praise, instruction, reprimanding, Process training, remediation and training on executive function skill | Other | Executive function treatment |
| Daily Life skill trainingeach child will receive 25 minute of DLS training which will focus on training children on Grooming, feeding, dressing undressing, toileting and community reintegration tasks aligned with facilitation fine motor skills for children and Using several techniques for ADL training including : prompting, shaping, forward and backward chaining, and modeling ,training children based on level of independency identified by WeeFIM score | Other | Executive function treatment, Treatment as usual |
| Sensory Integration /Processing trainingeach patient will receive 20 min of SI/SP training Manualized SI/SP intervention which will be used is based on the principles of sensory integration as outlined by Ayres ,such as deep pressure, brushing, weighted vests, and swinging will used , individually-tailored treatment activities might include activities such as using a carpeted scooter board while in the prone position to pull oneself up a ramp, then working to turn the scooter board around to ride down the ramp and land in a cushioned area of mats and pillows that are covered with various textures. Intervention is contextualized in play with active involvement of the child will be conducted in a large gym equipped with mats, a variety of suspended swings, large balls, a climbing wall, carpeted barrels, large inner tubes and foam blocks with opportunities for active, guided, sensory motor play. | Other | Executive function treatment, Treatment as usual |
Primary outcome
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
Time frame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
will be used for determining if participant is eligible for study and measuring change on self help skills.
Pediatric Functional Independent Measure (WeeFIM)
Time frame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
will be used to measure changes in self-care and social cognition skills .
Short Sensory Profile™ 2 (SSP2)
Time frame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
will be used to measure improvement in sensory processing skills .
1 secondary outcome
Visual Motor Integration Test (Beery-VMI)
Time frame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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.
BARA M YOUSEF, Bsc principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Function Strategies and Training, Daily Life skill training and Sensory Integration /Processing training in people with Autism Spectrum Disorder, run by Hamad General Hospital at 1 site in Qatar.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 Qatar. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BARA M YOUSEF, Bsc (0097450090427, baraot1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) (time frame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week). The study lists 3 primary outcomes in all. 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 6 May 2023.