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Integrated Life Skill Training and Executive Function Strategies in Children With ASD (ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Executive Function Strategies and Training
Daily Life skill training
Sensory Integration /Processing training
Sponsored by
Hamad General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Executive function treatment

Treatment as usual

Arm Description

Patient will receive Individual DLS and SI/SP training combined with EF strategies

patient will receive Individual DLS and SI/SP training.

Outcomes

Primary Outcome Measures

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.
Pediatric Functional Independent Measure (WeeFIM)
will be used to measure changes in self-care and social cognition skills .
Short Sensory Profile™ 2 (SSP2)
will be used to measure improvement in sensory processing skills .

Secondary Outcome Measures

Visual Motor Integration Test (Beery-VMI)
will be used to monitor changes in visual motor integration skills as part of fine motor skills

Full Information

First Posted
April 1, 2023
Last Updated
May 3, 2023
Sponsor
Hamad General Hospital
Collaborators
Universiti Sultan Zainal Abidin
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1. Study Identification

Unique Protocol Identification Number
NCT05829577
Brief Title
Integrated Life Skill Training and Executive Function Strategies in Children With ASD
Acronym
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad General Hospital
Collaborators
Universiti Sultan Zainal Abidin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Administration of assessment will be done by(individuals blinded of the outcome assessor) as an Independent evaluators, whose trained in the administration of study assessments, will conduct the pre-intervention, re assessment and post intervention assessments and this therapist will be blinded for intervention and control group, and thire qualification as follow : highly experienced therapist who has been licensed to practice occupational therapy for a mean of 10 years, and who had experience with working with children with ASD (mean = 5 years). also were trained on conducting these standardized assessment and certified on Wee FIM
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Executive function treatment
Arm Type
Experimental
Arm Description
Patient will receive Individual DLS and SI/SP training combined with EF strategies
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
patient will receive Individual DLS and SI/SP training.
Intervention Type
Other
Intervention Name(s)
Executive Function Strategies and Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Daily Life skill training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sensory Integration /Processing training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
Description
will be used for determining if participant is eligible for study and measuring change on self help skills.
Time Frame
Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Title
Pediatric Functional Independent Measure (WeeFIM)
Description
will be used to measure changes in self-care and social cognition skills .
Time Frame
Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Title
Short Sensory Profile™ 2 (SSP2)
Description
will be used to measure improvement in sensory processing skills .
Time Frame
Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week
Secondary Outcome Measure Information:
Title
Visual Motor Integration Test (Beery-VMI)
Description
will be used to monitor changes in visual motor integration skills as part of fine motor skills
Time Frame
Will be done before treatment ,after 7 week of treatment , and after treatment completion at 14 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BARA M YOUSEF, Bsc
Phone
0097450090427
Email
baraot1982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BARA M YOUSEF, Bsc
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
State/Province
Qatar -doha
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
INSTITUTIONAL REVIEW BOARD HAMAD MEDICAL CORPORATION
Phone
0097433521137
Ext
4025
Email
irb@hamad.qa

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrated Life Skill Training and Executive Function Strategies in Children With ASD

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