Autism Spectrum DisorderNCT06927518
Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With Autism Spectrum Disorder.
A study testing Receptive language intervention by using the total communication in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Receptive language intervention by using the total communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Irum Khara
Lahore, Punjab Province, 42000
Irum Khara, MS, 03203986465
About this study
Official title: Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Receptive language intervention by using the total communication
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receptive language intervention by using the total communicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual Therapy | Experimental | 14 participant will receive individual therapy. Each participant will receive 3 session per week for 2 Months. Receives: 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. Receives: Other: Receptive language intervention by using the total communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion29 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syeda Mariam Zahra, MS SLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927518
- Sponsor's protocol ID
- REC/RCR & AHS/24/0655
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38435203Akbar 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With
- ClinicalTrials.gov ID
- NCT06927518
- Acronym / sponsor ID
- REC/RCR & AHS/24/0655
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 29 Jul 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Therapy | Experimental | Other: Receptive language intervention by using the total communication14 participant will receive individual therapy. Each participant will receive 3 session per week for 2 Months. |
| Group Therapy | Active comparator | Other: Receptive language intervention by using the total communication16 participants will divided in 2 groups. each group will receive 3 session per week for 2 Months. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receptive language intervention by using the total communicationReceptive 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. | Other | Group Therapy, Individual Therapy |
Primary outcome
Laura Mize Teach Me To Talk receptive language checklist, Me To Talk receptive language checklist,
Time frame: 2 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 38435203Gajre 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.
- BackgroundAkbar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syeda Mariam Zahra, MS SLP principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receptive language intervention by using the total communication in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laura Mize Teach Me To Talk receptive language checklist, Me To Talk receptive language checklist, (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06927518, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.