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

NCT05829577 | Unknown DMC

• 1 other identifier: MRC-01-22-509
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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 .

Conditions

Autism Spectrum Disorder

Keywords

ASD

Outcome Measures

Primary Outcomes (3)

• 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.

  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 .

  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 .

  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 done before treatment ,after 7 week of treatment , and after treatment completion at 14 week

Study Arms (2)

Executive function treatment

EXPERIMENTAL

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

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.

Other: Daily Life skill training; Other: Sensory Integration /Processing training

Interventions

Executive Function Strategies and Training OTHER

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

Executive function treatment

Daily Life skill training OTHER

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

Executive function treatment; Treatment as usual

Sensory Integration /Processing training OTHER

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.

Executive function treatment; Treatment as usual

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Hamad General Hospital: lead
• Universiti Sultan Zainal Abidin: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar -doha, Qatar

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• BARA M YOUSEF, Bsc

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BARA M YOUSEF, Bsc

CONTACT

0097450090427; baraot1982@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapy Specialist

Model Details: 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 .

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 25, 2023
• Study Start: February 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)