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临床试验/CTRI/2024/11/077301
CTRI/2024/11/077301招募中不适用

To compare effectiveness of Sensory Integration Therapy Alone versus Its Combination with Behavioural Intervention in Enhancing Food Acceptance among Children with Autism: A Randomized Controlled Trial

Dr Muskaan Kaul1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
The primary outcome of the study will determine the effectiveness of

研究概览

简要总结

SUMMARY OF PROTOCOL

 TITLE- To compare effectiveness of Sensory Integration Therapy Alone versus Its Combination with Behavioural Intervention in Enhancing Food Acceptance among Children with Autism: A Randomized Controlled Trial

 AIM- The aim of the study is to provide empirical evidence on whether the combination of sensory integration therapy and behavioural intervention can offer a more effective solution in increasing acceptance of non-preferred food

 OBJECTIVES- The primary objective of the study is to determine the effectiveness of integrating behavioural strategies with sensory integration therapy to increase the acceptance of non-preferred food textures in children with ASD aged 3 years 0 months to 6 years 11 months.

 STUDY DESIGN- Randomized controlled trial

 STUDY SETTING- Data will be collected from children and their parents coming

to paediatrics (Sensory Integration) OPD of Occupational therapy Department.

  INCLUSION CRITERIA-

-Children with autism in the age group 3 years 0 months- 6 years 11 months

-Children receiving regular occupational therapy

-Children with feeding problems such as selective eating, meal time> 30 mins, food intake with only certain preferred food textures

    EXCLUSION CRITERIA-

Children diagnosed with any other comorbidity

-Children with dysphagia, tube feeding or any other oral-motor impairment

  METHODOLOGY-

Written consent will be taken from all the participated parents/caregivers.

-Demographic data of the child will be collected

Child will be screened using Indian Scale for assessment of Autism (ISAA) for severity of ASD and child sensory profile-2

Parents will be asked about their child’s food preferences based on texture and will have to complete a non-preferred food texture checklist , where they will be asked to write down 2 most non-preferred food textures of the child.

Children will be randomly allocated to the groups

Child will need to have a 60-70% attendance to remain included in the study

 INTERVENTION

CONTROL GROUP -

Regular Occupational Therapy Protocol which comprises activities based on sensory motor and sensory integration approaches

(activities addressing tactile, vestibular, proprioceptive, oral sensory issues)

Duration of each session -30 minutes,2 times/week

 EXPERIMENTAL GROUP-

In addition to receiving the therapy provided to the control group, participants in the experimental group will also receive the following additional intervention

 During each session the child will be presented both the non-preferred food textures.

The therapist will present the 1st non preferred food texture in front of the child and will give the instruction - ‘take a bite’.

 If the child engages with the food, social reinforcer will be presented to the child.

Social reinforcer will be given by the therapist. Commonly used social reinforcers like (praises, claps, high fives) will be used.

The food will be presented for a duration of 30 seconds

If the child fails to engage with the food item within the given time span, no reinforcer will be given, the food item will be removed and the next food item will be presented, and the procedure will be continued.

A total of 6 trials of the food items will be presented during each session (i.e., each food item will be presented to the child three times)

Duration of each session will be around 10-15 minutes ,2 times per week

This procedure will be continued until the child accepts both the 2 food items or reaches a maximum of 8 weeks.

 Parents will be explained to carry out the intervention at home

  Reinforcer will be presented according to the following hierarchical levels-

(Adapted from- Koegel, Robert & Bharoocha, Amber & Ribnick, Courtney & Ribnick, Ryan & Bucio, Mario & Fredeen, Rosy & Koegel, Lynn. (2011). Using Individualized Reinforcers and Hierarchical Exposure to Increase Food Flexibility in Children with Autism Spectrum Disorders. Journal of autism and developmental disorders. 42. 1574-81. 10.1007/s10803-011-1392-9.)

  

Description

 Hierarchical level of acceptance

  |0

Refuses to try food (with or without disruptive behaviour)

  |1

Touches the food and motions it towards mouth (does not include touching the food as an act of disruptive behaviour such as throwing the food)

  |2

Puts the food to lips

|3

Bites the food

  |4

Bites and puts in mouth, refuses to swallow

  |5

Chews the food but refuses to swallow

  |6

Swallow the food reluctantly

  |7

Accepts the food without any signs of displeasure or disruptive behaviour

   Baseline assessment (0 weeks)

Mid-week assessment (4 weeks)

Post intervention assessment (8 weeks)

Procedure- Child will be presented the food item one by one and asked to take a bite and will be observed for eating behaviour

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • children with autism in the age range -children receiving regular occupational therapy -children with feeding problems such as selective eating,meal time more than thirty mintutes,food intake with onky certain preferred food textures.

排除标准

  • Children diagnosed with any other comorbidity -Children with dysphagia, tube feeding or any other oral motor impairment.

结局指标

主要结局

The primary outcome of the study will determine the effectiveness of

时间窗: Baseline assessment (0 weeks) | Mid-week assessment (4 weeks) | Post intervention assessment (8 weeks)

integrating behavioural strategies with sensory integration therapy to

时间窗: Baseline assessment (0 weeks) | Mid-week assessment (4 weeks) | Post intervention assessment (8 weeks)

increase the acceptance of non-preferred food texture in children with ASD

时间窗: Baseline assessment (0 weeks) | Mid-week assessment (4 weeks) | Post intervention assessment (8 weeks)

aged 3 years 0 months to 6 years 11 months.

时间窗: Baseline assessment (0 weeks) | Mid-week assessment (4 weeks) | Post intervention assessment (8 weeks)

The secondary outcome will be to correlate the acceptance of non preferred food textures with severity of autism

时间窗: Baseline assessment (0 weeks) | Mid-week assessment (4 weeks) | Post intervention assessment (8 weeks)

次要结局

  • The secondary outcome is to correlate the acceptance of non preferred food textures with severity of autism(Baseline assessment (0 weeks))

研究者

发起方
Dr Muskaan Kaul
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Usha Kasar

Occupational Therapy Training School and Centre,Seth GSMC & KEMH Mumbai

研究点 (1)

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