Autism Spectrum DisordersNCT06292520
Comparison of ABLLS-R and Portage Guide in the Development of Receptive Language Skills Autism Spectrum Disorder.
A study testing Portage Guide Protocol and ABLLS-R protocol in people with Autism Spectrum Disorders and Non-verbal Learning Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders, Non-verbal Learning Disorder
- What is being tested?
- Portage Guide Protocol and ABLLS-R protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2023to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with autism spectrum disorder with mild to moderate severity level will be included in the study.
- The age range of the children will be from three years to seven years.
Who cannot join
- Children with other neurological disorders or any comorbid conditions will be excluded from the study.
- Children who are not participated in any kind of other intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABLLS-R and Portage Guide in the Development of Receptive Language Skills in Children With Autism Spectrum Disorder.
Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. However, some studies found that toddlers and kids with ASD had a relatively greater impairment in receptive language skills than in expressive language skills. The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder (N=12).
The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABLLS-R protocol and other will receive Interventions under portage guide protocol. The data will be analysed by using SPSS 22 statistical software. The results of the study of both the groups will be compared and conclusion will be made on the basis of results. Receptive language skills are crucial for communication and social interaction. Research comparing these assessment tools can contribute to the development of more effective early intervention programs for children with ASD. By identifying the most appropriate assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes. By understanding the strengths and limitations of each assessment tool, professionals can create more individualized treatment plans for children with ASD
- Being tested
- Portage Guide Protocol, ABLLS-R protocol
- 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.
Portage Guide ProtocolOther
Portage Guide Protocol will be given to this group The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABL
ABLLS-R protocolOther
ABLLS-R protocol will be given to this group
| Study group | Role | What they receive |
|---|---|---|
| ABLLS-R protocol | Experimental | The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and compare their effectiveness in developing the Receptive. Receives: Other: ABLLS-R protocol |
| Portage Guide Protocol | Experimental | The study will evaluate Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder. Receives: Other: Portage Guide Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABLLS-R for the development of receptive language in children with Autism
Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) is a criterion referenced assessment tool, curriculum planning manual, and tracking system for the prerequisite skills required for the development of basic language and communication as well as skills required to support learning in significant academic, adaptive, and motor domains assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes.
Measured: 6 months
Portage Guide for the development of receptive language in children with Autism
A home-based early intervention program called Portage Guide to Early Education is for preschoolers who are developmentally delayed. It consists of a method of teaching parents how to instruct their own children, a set of reading materials, and the triadic model of service delivery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start10 Jun 2023
- Primary completion20 Aug 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleena Irum, MS-SLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292520
- Sponsor's protocol ID
- 4847
- Status last verified
- Mar 2024
- First submitted
- 25 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maljaars J, Noens I, Scholte E, van Berckelaer-Onnes I. Language in low-functioning children with autistic disorder: differences between receptive and expressive skills and concurrent predictors of language. J Autism Dev Disord. 2012 Oct;42(10):2181-91. doi: 10.1007/s10803-012-1476-1.
PubMed 22350453Sket GM, Overfeld J, Styner M, Gilmore JH, Entringer S, Wadhwa PD, Rasmussen JM, Buss C. Neonatal White Matter Maturation Is Associated With Infant Language Development. Front Hum Neurosci. 2019 Dec 17;13:434. doi: 10.3389/fnhum.2019.00434. eCollection 2019.
PubMed 31920593Plesa Skwerer D, Jordan SE, Brukilacchio BH, Tager-Flusberg H. Comparing methods for assessing receptive language skills in minimally verbal children and adolescents with autism spectrum disorders. Autism. 2016 Jul;20(5):591-604. doi: 10.1177/1362361315600146. Epub 2015 Sep 25.
PubMed 26408635Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
PubMed 30078460
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABLLS-R and Portage Guide in the Development of Receptive Language Skills in Children With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06292520
- Acronym / sponsor ID
- 4847
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 5 Mar 2024 (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.
Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. However, some studies found that toddlers and kids with ASD had a relatively greater impairment in receptive language skills than in expressive language skills. The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder (N=12).
The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABLLS-R protocol and other will receive Interventions under portage guide protocol. The data will be analysed by using SPSS 22 statistical software. The results of the study of both the groups will be compared and conclusion will be made on the basis of results. Receptive language skills are crucial for communication and social interaction. Research comparing these assessment tools can contribute to the development of more effective early intervention programs for children with ASD. By identifying the most appropriate assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes. By understanding the strengths and limitations of each assessment tool, professionals can create more individualized treatment plans for children with ASD
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABLLS-R protocol | Experimental | Other: ABLLS-R protocolThe study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and compare their effectiveness in developing the Receptive. |
| Portage Guide Protocol | Experimental | Other: Portage Guide ProtocolThe study will evaluate Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with autism spectrum disorder with mild to moderate severity level will be included in the study.
- The age range of the children will be from three years to seven years.
Key exclusion criteria (2 listed)
- Children with other neurological disorders or any comorbid conditions will be excluded from the study.
- Children who are not participated in any kind of other intervention.
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 |
|---|---|---|
| Portage Guide ProtocolPortage Guide Protocol will be given to this group The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABL | Other | Portage Guide Protocol |
| ABLLS-R protocolABLLS-R protocol will be given to this group | Other | ABLLS-R protocol |
Primary outcome
ABLLS-R for the development of receptive language in children with Autism
Time frame: 6 months
Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) is a criterion referenced assessment tool, curriculum planning manual, and tracking system for the prerequisite skills required for the development of basic language and communication as well as skills required to support learning in significant academic, adaptive, and motor domains assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes.
Portage Guide for the development of receptive language in children with Autism
Time frame: 6 months
A home-based early intervention program called Portage Guide to Early Education is for preschoolers who are developmentally delayed. It consists of a method of teaching parents how to instruct their own children, a set of reading materials, and the triadic model of service delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 22350453Maljaars J, Noens I, Scholte E, van Berckelaer-Onnes I. Language in low-functioning children with autistic disorder: differences between receptive and expressive skills and concurrent predictors of language. J Autism Dev Disord. 2012 Oct;42(10):2181-91. doi: 10.1007/s10803-012-1476-1.
- Background: PubMed 31920593Sket GM, Overfeld J, Styner M, Gilmore JH, Entringer S, Wadhwa PD, Rasmussen JM, Buss C. Neonatal White Matter Maturation Is Associated With Infant Language Development. Front Hum Neurosci. 2019 Dec 17;13:434. doi: 10.3389/fnhum.2019.00434. eCollection 2019.
- Background: PubMed 26408635Plesa Skwerer D, Jordan SE, Brukilacchio BH, Tager-Flusberg H. Comparing methods for assessing receptive language skills in minimally verbal children and adolescents with autism spectrum disorders. Autism. 2016 Jul;20(5):591-604. doi: 10.1177/1362361315600146. Epub 2015 Sep 25.
- Background: PubMed 30078460Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorders
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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. This study is not recruiting at the moment.
Aleena Irum, 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 Portage Guide Protocol and ABLLS-R protocol in people with Autism Spectrum Disorders and Non-verbal Learning 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABLLS-R for the development of receptive language in children with Autism (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT06292520, which also lists 4 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 5 Mar 2024.