跳至主要内容
临床试验/CTRI/2025/01/078943
CTRI/2025/01/078943进行中(未招募)不适用

Studying the domains of communication and interaction skills according to severity of autism spectrum disorder A cross sectional study

DrSushant Sarang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
To screen patients using Indian Scale for assessment of Autism (ISAA)

研究概览

简要总结

The domains of communication and interaction skills

according to severity of autism spectrum disorder a cross sectional  study

Aim This study attempts to study the relationship between severity of autism and communication and interaction skills

Objectives-

1 To screen patients using Indian Scale for assessment of Autism (ISAA)

  1. To administer ACIS (Assessment of communication and interaction skills) scale in mild, moderate and severe group of children with autism spectrum disorder.

  2. To study the various domains of communication and interaction skills within mild, moderate and severe group of participants with autism spectrum disorder.

  3. To study relationship between the various domains of assessment of communication and interaction skills according to the severity of autism spectrum disorder.

Study Design : Quantitative, cross sectional observational study

Study Duration: 18 months

Study Setting: Study will be conducted in a tertiary care hospital.

Sampling Technique: Stratified Sampling

Sample Size: 60 (mild-20, moderate-20 , severe20)

Extensive literature review and existing research on the outcome of children with autism revealed limited references articles.

Conducting both pilot and final study is unfeasible due to several constraints such as absence of multicenter participation, time limitations and limited number of cases meeting the inclusion criteria . It is planned to enrol a total number of 60 participants (mild-20, moderate- 20 , severe20) over the course by including all the patients who meet inclusion criteria.

INCLUSION CRITERIA

Patients with ASD, ASD with ADHD

Male and female gender

Age 2 years to 8 years

Parents who give consent for the study

EXCLUSION CRITERIA

Selective mutism

Intellectual disability without ASD

Stereotypic movement disorder

Social (pragmatic) disorder

PROCEDURE

Approval  taken from EIC.

Permission for use of ACIS (Assessment of communication

and interaction skills) scale taken.

Child with autism spectrum disorder referred in

occupational therapy department would be enrolled in

study with the consent.

Demographic details would be noted. Demographics will be

discussed in discussion .

ISAA (Indian scale for assessment of autism) scale would be

administered in an area other than the sensory integration

unit. i.e, Occupational therapy mental health OPD unit.

Depending on ISAA score participants would be grouped as

mild, moderate and severe.

ACIS scale would be administered in the sensory integration

unit.

Open, simulated life role situation (sensory integration unit)

would be used for assessment of ACISAccording to ASICS, ‘Simulated life role situation’ is defined as - the therapist attempts to simulate communication and  interaction situations that reflects the clients life role.

According to ACIS  is defined as client is in an

unstructured situation.

Relationship between the severity of autism spectrum

disorder and communication and interaction skills will be

studied.

Session 1- Demographics would be taken, ISAA would be

administered

Session 2- ACIS would be done in open, simulated life role

situation, SI unit.

Study toolsIndian scale for assessment of autism (ISAA)

ISAA is an objective assessment tool for persons with autism which uses observation, clinical evaluation of behavior, testing by  interaction with the subject and also information supplemented by parents or caretakers in order to diagnose autism. ISAA consists of 40 items rated on a 5-point scale ranging from 1 (never) to 5 (always).

The 40 items of ISAA are divided under six domains as given

Domain-I Social Relationship and Reciprocity

Domain-II Emotional Responsiveness

Domain-III Speech - Language and Communication

Domain-IV Behaviour Patterns

Domain-V Sensory Aspects

Domain-IV Cognitive Component

Interpretation:

  1. <70 -no autism

  2. 70“ 106 - mild autism

  3. 107-153 -moderate autism

  4. 153 -severe autism

Total time taken for administration of ISAA is 20-30 minutes.19

Assessment of communication and interaction skills (ACIS)

The ACIS is an observational assessment that gathers data on the skill that persons demonstrate when communicating and interacting with others in an occupation. The ACIS gathers data on skill as it is  exhibited during performance of an occupational form and/or within a social group of which the person is a part.

The scale will be administered on participants in open setting. The settings were open, parallel group, cooperative group and one-onone.

The scale has three domains namely physicality, information

exchange and relations. Each domain is further divided into

subdomains which are;

Physicality- Contacts, Gazes, Gestures, Maneuvres, Orients,

Posture.

Information Exchange - Articulates, Asserts, Asks, Engages,

Expresses, Modulates, Shares, Speaks, Sustains.

Relations - Collaborates, Confirms, Focuses, Relates, Respects.

Each of the above can be rated between 1 to 4;

4 = skill supports ongoing social action

3 = questionable skill, however there is no disruption in ongoing

social action

2 = ineffective skill which impacts ongoing social action

1 = deficit skill which causes an unacceptable delay or break down in social action

The total administration time varies from 20-60 minutes.

Observation time ranges from 15-45 minutes.

Rating time ranges from 5-20 minutes depending on

experience using the ACIS.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Patients with ASD, ASD with ADHD Male and female gender Age 2 years to 8 years Parents who give consent for the study.

排除标准

  • Selective mutism Intellectual disability without ASD Stereotypic movement disorder Social (pragmatic) disorder.

结局指标

主要结局

To screen patients using Indian Scale for assessment of Autism (ISAA)

时间窗: 1 week(1 day)

次要结局

  • To administer ACIS (Assessment of communication and interaction skills) scale in mild, moderate and severe group of children with autism spectrum disorder.(3. To study the various domains of communication and interaction skills within mild, moderate and severe group of participants with autism spectrum disorder.)

研究者

发起方
DrSushant Sarang
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sushant Sarang

Seth G.S. Medical College and KEM Hopsital

研究点 (1)

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