NCT06927518

Brief Summary

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and social interaction and the presence of restricted, repetitive behaviors. Atypical behaviors, conditioning, and difficulties interacting with others are emblems of Autism spectrum disorder (ASD). Autism spectrum disorder (ASD) frequently affects receptive language skills essential for comprehension and communication. Early intervention is crucial for optimizing language outcomes. This randomized controlled trial (RCT) investigates the comparative efficacy of receptive language intervention (RLI) in group versus individual therapy settings for preschool children with ASD. This study aims to investigate the efficacy of receptive language intervention (RLI) in group versus individual therapy settings for preschool children with Autism Spectrum Disorder (ASD) aged 3-5 years. The study aims to address the knowledge gap regarding optimal delivery methods for receptive language interventions. Twenty preschool children (ages 3-5) with ASD will be randomly assigned to either group (n=10) or individual (n=10) therapy conditions. Outcome measures will assess by Laura Mize Teach Me To Talk receptive language checklist, noted before therapy and after completing 20 sessions post-therapy (after 7 weeks). Statistical analysis was done using SPSS 20. An Independent t-test was utilized to see any difference between groups. The study's findings will inform evidence-based practice, enhancing receptive language skills in preschool children with ASD. The study could give precious perceptivity to clinicians, preceptors, and policymakers, helping them make informed, substantiation-based opinions about the most effective and doable intervention strategies. The expected outcomes include comparable receptive language outcomes between group and individual therapy, identification of setting-specific benefits and challenges, and child characteristics influencing treatment response.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 7, 2025

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Laura Mize Teach Me To Talk receptive language checklist, Me To Talk receptive language checklist,

    Laura Mize, a pediatric speech-language pathologist, created the "Teach Me To Talk" resources, including a Receptive Language Skills Checklist. This checklist is designed to help parents, therapists, and educators assess and track a child's receptive language development, particularly for toddlers and young children with language delays or disorders, including autism.

    2 months

Study Arms (2)

Individual Therapy

EXPERIMENTAL

14 participant will receive individual therapy. Each participant will receive 3 session per week for 2 Months.

Other: Receptive language intervention by using the total communication

Group Therapy

ACTIVE COMPARATOR

16 participants will divided in 2 groups. each group will receive 3 session per week for 2 Months.

Other: Receptive language intervention by using the total communication

Interventions

Receptive language intervention using Total Communication (TC) for children with autism can be highly effective. Total Communication involves using a combination of communication methods to support language comprehension and expression. It recognizes that individuals with autism often benefit from multi-modal communication rather than relying solely on spoken language.

Group TherapyIndividual Therapy

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 3 to 5 years diagnosed with ASD.
  • Children who are able to attend regular therapy sessions as scheduled in the study (either group or individual therapy).
  • Both male and female will be included.

You may not qualify if:

  • Children with co-occurring severe medical conditions.
  • Children who have already received intensive speech and language therapy for receptive language skills within the last 6 months.
  • Children with behavioral issues so severe (e.g., aggression, extreme hyperactivity) that they might disrupt group therapy sessions or be unable to focus in individual therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irum Khara

Lahore, Punjab Province, 42000, Pakistan

RECRUITING

Related Publications (2)

  • Gajre MP, Shah M, Pradhan SV, Aseri H. Examining the Impact of Group-Based Social Skills Intervention in Autistic Children Aged Eight to 15 Years. Cureus. 2024 Feb 1;16(2):e53376. doi: 10.7759/cureus.53376. eCollection 2024 Feb.

    PMID: 38435203BACKGROUND
  • Akbar RF, Kiyani HS, Saqulain G. Effectiveness of group therapy versus individual therapy in acquisition of pre-linguistic skills in children with expressive language disorders. The Rehabilitation Journal. 2023.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Syeda Mariam Zahra, MS SLP

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Syeda Mariam Zahra, MS SLP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

July 29, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations