跳至主要内容
临床试验/CTRI/2024/10/075858
CTRI/2024/10/075858尚未招募不适用

Comparison of vocabulary and gestures between children with autism spectrum disorder and global developmental delay

Arunima OG1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年10月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
The tools used in the study provide scores that reflect the early vocabulary and gestures used by children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD). By comparing these scores, we can identify differences and patterns in how each group uses words and gestures.

研究概览

简要总结

Project Title

Comparison of Vocabulary and Gestures Between Children with Autism Spectrum Disorder and Global Developmental Delay

Type of Study

Prospective Cross-Sectional Study

Aims & Objectives

Primary Objective:

  • Identify verbal comprehension, production, and gestures in children diagnosed with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD).

  • Assess spontaneous speech production of vocabulary and gestures in children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD).

Secondary Objective:

  • Analyze speech error patterns in Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD) groups.

Justification for Study

Current literature often assesses developmental milestones across multiple domains but lacks a focused examination of specific language components in children with ASD and GDD. The few existing studies primarily characterize communication patterns using the Communication Developmental Inventory (CDI) in Western populations. Adaptations of CDI to Indian languages (Kannada and Malayalam) exist, yet research on large and varied populations is limited.

This study will validate the adapted versions of the MacArthur-Bates Communicative Development Inventories (MCDI) in Kannada and Malayalam, exploring cultural influences on communication development. By profiling vocabulary and gestures, we aim to enhance intervention strategies tailored to the cultural and linguistic context of children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD).

Departments Involved

Department of Speech and Hearing, Therapy section, 3rd floor, Baliga block, Kasturba Hospital

Study Period

10 months

Sample Size

Sample size calculated using G*power 3.1.9.4 with a target of 39 children per group (Autism Spectrum Disorder  and Global Developmental Delay ) based on expected means and standard deviations.

  1. Materials and Methods

Inclusion Criteria:

  • Diagnosis of ASD or GDD based on DSM-V.

  • Children with a language age below 3 years on REELS-3.

Exclusion Criteria:

  • Associated deficits (e.g., cerebral palsy, seizures, visual or hearing impairment).

  • Language age above 3 years on REELS-3.

Statistical Methods

  • Descriptive Statistics: Mean and SD for normally distributed data; median and IQR for non-normally distributed data.

  • Inferential Statistics: t-test or Mann-Whitney U test for group comparisons; significance set at p < 0.05.

Tools Used

  1. Adapted MCDI (Kannada and Malayalam)- Measures early speech and gestures (Dr. Veena KD / Dr. Sunila John, 2014).

  2. Receptive Expressive Emergent Language Test, Third Edition- Measures receptive and expressive language (Bzoch, League, and Brown, 2003).

  3. Com DEALL - Assesses various developmental skills (Prathibha Karanth, 2011).

Procedure:

  1. Obtain clearance from Institutional Review Committee (IRC) and Ethics Committee (IEC).

  2. Identify and recruit participants meeting the inclusion criteria from the Department of Speech and Hearing.

  3. Obtain informed consent from parents.

  4. Administer the adapted MCDI and conduct play sessions to elicit spontaneous speech from children.

  5. A picture will be selected for the vocabulary and gestures and will be presented to the child during the play session. The child will be asked to name the picture to elicit spontaneous productions.

6.The spontaneous productions will be audio-recorded and stored  for later analysis.

7.Com DEALL , a developmental checklist would also be administered as a part of routine evaluation to evaluate the gross motor, fine motor skills, activities of daily living, receptive language, expressive language, cognitive skills, social skills and emotional skills.

Outcome Measures

The study obtains scores from both the scale and the checklist. This provides the measure of early vocabulary and gestures present in children with Autism Spectrum Disorder  and Global Developmental Delay. This will help us in comparing the patterns of vocabulary and gestures between both the groups.

Potential Risks and Benefits

Risks: Minimal discomfort or anxiety from completing questionnaires; mitigated by allowing sufficient time.

Benefits: Contributing to understanding specific vocabulary patterns, aiding in individualized therapy plans for children with Autism Spectrum Disorder  and Global Developmental Delay.

Ethical Considerations

Approval from IEC and CTRI registration prior to participant recruitment.

Budget

N/A

Review of Literature

Studies highlight significant differences in language and communication development between children with Autism Spectrum Disorder  and Global Developmental Delay. For instance:

  • Luyster et al. (2007) noted delays in vocabulary and nonverbal communication in children with Autism Spectrum Disorder .

  • Lee et al. (2018) emphasized social engagement differences, with children with Global Developmental Delay showing more emotional engagement than those with Autism Spectrum Disorder .

  • Taddei et al. (2023) reported delays in communication and social-emotional skills for both groups, with distinct profiles emerging.

  • Wang et al. (2021) identified developmental imbalances in language and reasoning, indicating different areas of delay for Autism Spectrum Disorder  and Global Developmental Delay children.

These studies underscore the necessity for in-depth investigations of language components to inform targeted interventions for diverse populations.

This structured approach is aimed at addressing the gap in understanding and enhancing the clinical practice related to language development in children with Autism Spectrum Disorder  and Global Developmental Delay.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children diagnosed with ASD and children diagnosed with global developmental disorder (Diagnosis based on DSM-V).
  • Children whose language age in REELS-3 is below 3 years.

排除标准

  • Children with other associated deficits like syndromes cerebral palsy, seizures, Hearing and/or Visual impairment.
  • Language age in REELS 3 is greater than 3 years.

结局指标

主要结局

The tools used in the study provide scores that reflect the early vocabulary and gestures used by children with Autism Spectrum Disorder (ASD) and Global Developmental Delay (GDD). By comparing these scores, we can identify differences and patterns in how each group uses words and gestures.

时间窗: 10 months

次要结局

未报告次要终点

研究者

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

Arunima OG

Manipal College of Health Professions Manipal Academy of Higher Education

研究点 (1)

Loading locations...

相似试验