Clinical trial NCT05829577: Integrated Life Skill Training and Executive Function Strategies in Children With ASD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Lead sponsor: Hamad General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Sultan Zainal Abidin
First posted: 2023-04-25
Enrollment: 92
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 .
Primary purpose: TREATMENT

Brief 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 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 :

1. Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) will be used for determining the inclusion criteria and measuring improvement on self help skills,
2. Pediatric Functional Independent Measure (WeeFIM): will be used to measure improvement in self-care and social cognition skills,
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 .

Primary outcomes:
measure: Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
timeFrame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
measure: Pediatric Functional Independent Measure (WeeFIM)
timeFrame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
measure: Short Sensory Profile™ 2 (SSP2)
timeFrame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Secondary outcomes:
measure: Visual Motor Integration Test (Beery-VMI)
timeFrame: Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
state: Qatar -doha
Study officials:
affiliation: Hamad Medical Corporation
name: BARA M YOUSEF, Bsc
role: PRINCIPAL_INVESTIGATOR
References: