Autism Spectrum DisorderNCT05359757
Naturalistic Teaching Strategies in Children With Autism
A study testing Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorder and PECS Therapy only in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will show the effect of naturalistic teaching strategies and picture exchange communication systems in children with an autism spectrum disorder. There will be two groups in this study. One control group and the other experimental group. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorder and PECS Therapy only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Nov 2021to 10 Apr 2022
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who will be diagnosed with autism spectrum disorder and with speech and language impairments and will fall in the chronological age of language development (3-8) years
- Both genders
- Children who will have a vocabulary of 0-10 meaningful words
- Children with mild and moderate autism
Who cannot join
- Children already taking speech therapy sessions
- Children with severe to a profound level.
- Children with any other disorder along with autism
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 534000
About this study
Official title: Effect of Naturalistic Teaching Strategies in Children With Autism Spectrum Disorder
The study will show the effect of naturalistic teaching strategies and picture exchange communication systems in children with an autism spectrum disorder. There will be two groups in this study. One control group and the other experimental group.
One group will be provided with the naturalistic teaching strategies and pecs therapy both and the other group will be provided with the PECS therapy. The research will be conducted within the duration of six months after the approval from BASR.
The two groups will be first assessed using the portage early education program and pecs manual. After 20 sessions of respective therapeutic techniques, both of the groups will be reassessed. The results of both of the groups will be then compared and conclusions will be drawn.
Read the detailed description
The Naturalistic Teaching approach is both adaptive and reactive to the needs of the kids with autism. Its methods are designed to be incorporated into the routines of children with an autism spectrum disorder. The naturalistic methods are intended to mimic the natural instructions a child receives in a variety of contexts.
PictureExchange Communication System (PECS) is a unique communication training program that was developed as a means of evading some shortcomings associated with these strategies. Many individuals with autism are candidates for augmentative and alternative communication (AAC) systems, either to supplement (i.e., augment) their existing speech or to act as their primary (i.e., alternative) method of expressive communication. Presently, aided, picture-based AAC systems are used more frequently and successfully with individuals with ASD. PECS consists of six phases and begins by teaching an individual to give a single picture of a desired item or action to a "communicative partner" who immediately honors the exchange as a request.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorder, PECS Therapy only
- 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.
Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorderOther
In this group, the patients will be provided with both the naturalistic therapeutic techniques the PECS Therapy.
A baseline of the kids in this group will be made using the portage guide and PECS
- Incidental teaching trial, natural language paradigm, and time delay concepts will be incorporated in the therapy sessions and communication using picture cards will be made.
- 40 minutes session will be conducted in which 20 minutes session will be for naturalistic teaching techniques and 20 minutes will be for PECS.
- This will be followed for 30 sessions
PECS Therapy onlyOther
A baseline will be developed using the portage guide and PECS.
- Communication strategies using the PECS picture cards will be made
- 30 minutes session will be conducted
- This will be followed for 30 sessions
| Study group | Role | What they receive |
|---|---|---|
| Naturalistic therapeutic techniques and PECS therapy. | Experimental | Not described Receives: Other: Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorder; Other: PECS Therapy only |
| PECS therapy Only. | Active comparator | Not described Receives: Other: PECS Therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portage Early Education Program for Naturalistic Teaching Strategies for children with autism spectrum disorder.
Portage Guide to Early Education is a naturalistic teaching strategy. It consists of a set of reading materials and a method of training parents to teach their own children.It is a valid and reliable tool and is used in clinics as an assessment method. These strategies are treatment procedures in the natural environment, and promotes motivation, functional relationships, generalization and maintenance for children with autism spectrum disorder. The four parts of this technique includes: Natural Language Paradigm, Speech/Play Enhancement for Autistic Kids, Multiple Incidental Teaching Sessions, and Time Delay. These training procedures are incorporate components and strategies which are known to facilitate acquisition, generalization and maintenance of new behaviors. This teaching strategies are designed for therapists, parents and siblings.
Measured: 30 Sessions (2 Months)
Picture Exchange Communication System (PECS), an AAC system designed to minimize difficulties with communication skills experienced by individuals with Autism Spectrum Disorder
The Picture Exchange Communication System (PECS) is an AAC system designed specifically to minimize difficulties with communication skills experienced by individuals with ASD. Presently, aided, picture-based AAC systems are used more frequently and successfully with individuals with ASD. PECS consists of six phases and begins by teaching an individual to give a single picture of a desired item or action to a "communicative partner" who immediately honors the exchange as a request. The system goes on to teach discrimination of pictures and how to put them together in sentences. In the more advanced phases, individuals are taught to use modifiers, answer questions and comment. The primary goal of PECS is to teach functional communication. It is a treatment choice for teaching speech to non-verbal children with autism but there is little empirical evidence available regarding the usefulness of picture exchange communication system in managing social and communication issues in autism.
Measured: 30 Sessions ( 2 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start25 Nov 2021
- Primary completion1 Mar 2022
- Study completion10 Apr 2022
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 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
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nameeka Shahid, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359757
- Sponsor's protocol ID
- REC/Lhr/21/0627 Maha Nasir
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thiemann-Bourque K, Brady N, McGuff S, Stump K, Naylor A. Picture Exchange Communication System and Pals: A Peer-Mediated Augmentative and Alternative Communication Intervention for Minimally Verbal Preschoolers With Autism. J Speech Lang Hear Res. 2016 Oct 1;59(5):1133-1145. doi: 10.1044/2016_JSLHR-L-15-0313.
PubMed 27679841Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.
PubMed 31949163Ganz JB, Simpson RL. Effects on communicative requesting and speech development of the Picture Exchange Communication System in children with characteristics of autism. J Autism Dev Disord. 2004 Aug;34(4):395-409. doi: 10.1023/b:jadd.0000037416.59095.d7.
PubMed 15449515Mukherjee SB. Autism Spectrum Disorders - Diagnosis and Management. Indian J Pediatr. 2017 Apr;84(4):307-314. doi: 10.1007/s12098-016-2272-2. Epub 2017 Jan 19.
PubMed 28101829
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Naturalistic Teaching Strategies in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05359757
- Acronym / sponsor ID
- REC/Lhr/21/0627 Maha Nasir
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 4 May 2022 (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.
The study will show the effect of naturalistic teaching strategies and picture exchange communication systems in children with an autism spectrum disorder. There will be two groups in this study. One control group and the other experimental group.
One group will be provided with the naturalistic teaching strategies and pecs therapy both and the other group will be provided with the PECS therapy. The research will be conducted within the duration of six months after the approval from BASR.
The two groups will be first assessed using the portage early education program and pecs manual. After 20 sessions of respective therapeutic techniques, both of the groups will be reassessed. The results of both of the groups will be then compared and conclusions will be drawn.
Detailed description
The Naturalistic Teaching approach is both adaptive and reactive to the needs of the kids with autism. Its methods are designed to be incorporated into the routines of children with an autism spectrum disorder. The naturalistic methods are intended to mimic the natural instructions a child receives in a variety of contexts.
PictureExchange Communication System (PECS) is a unique communication training program that was developed as a means of evading some shortcomings associated with these strategies. Many individuals with autism are candidates for augmentative and alternative communication (AAC) systems, either to supplement (i.e., augment) their existing speech or to act as their primary (i.e., alternative) method of expressive communication. Presently, aided, picture-based AAC systems are used more frequently and successfully with individuals with ASD. PECS consists of six phases and begins by teaching an individual to give a single picture of a desired item or action to a "communicative partner" who immediately honors the exchange as a request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naturalistic therapeutic techniques and PECS therapy. | Experimental | Other: Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorder, Other: PECS Therapy only |
| PECS therapy Only. | Active comparator | Other: PECS Therapy only |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who will be diagnosed with autism spectrum disorder and with speech and language impairments and will fall in the chronological age of language development (3-8) years
- Both genders
- Children who will have a vocabulary of 0-10 meaningful words
- Children with mild and moderate autism
Key exclusion criteria (3 listed)
- Children already taking speech therapy sessions
- Children with severe to a profound level.
- Children with any other disorder along with autism
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 |
|---|---|---|
| Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorderIn this group, the patients will be provided with both the naturalistic therapeutic techniques the PECS Therapy. A baseline of the kids in this group will be made using the portage guide and PECS * Incidental teaching trial, natural language paradigm, and time delay concepts will be incorporated in the therapy sessions and communication using picture cards will be made. * 40 minutes session will be conducted in which 20 minutes session will be for naturalistic teaching techniques and 20 minutes will be for PECS. * This will be followed for 30 sessions | Other | Naturalistic therapeutic techniques and PECS therapy. |
| PECS Therapy onlyA baseline will be developed using the portage guide and PECS. * Communication strategies using the PECS picture cards will be made * 30 minutes session will be conducted * This will be followed for 30 sessions | Other | Naturalistic therapeutic techniques and PECS therapy., PECS therapy Only. |
Primary outcome
Portage Early Education Program for Naturalistic Teaching Strategies for children with autism spectrum disorder.
Time frame: 30 Sessions (2 Months)
Portage Guide to Early Education is a naturalistic teaching strategy. It consists of a set of reading materials and a method of training parents to teach their own children.It is a valid and reliable tool and is used in clinics as an assessment method. These strategies are treatment procedures in the natural environment, and promotes motivation, functional relationships, generalization and maintenance for children with autism spectrum disorder. The four parts of this technique includes: Natural Language Paradigm, Speech/Play Enhancement for Autistic Kids, Multiple Incidental Teaching Sessions, and Time Delay. These training procedures are incorporate components and strategies which are known to facilitate acquisition, generalization and maintenance of new behaviors. This teaching strategies are designed for therapists, parents and siblings.
Picture Exchange Communication System (PECS), an AAC system designed to minimize difficulties with communication skills experienced by individuals with Autism Spectrum Disorder
Time frame: 30 Sessions ( 2 Months)
The Picture Exchange Communication System (PECS) is an AAC system designed specifically to minimize difficulties with communication skills experienced by individuals with ASD. Presently, aided, picture-based AAC systems are used more frequently and successfully with individuals with ASD. PECS consists of six phases and begins by teaching an individual to give a single picture of a desired item or action to a "communicative partner" who immediately honors the exchange as a request. The system goes on to teach discrimination of pictures and how to put them together in sentences. In the more advanced phases, individuals are taught to use modifiers, answer questions and comment. The primary goal of PECS is to teach functional communication. It is a treatment choice for teaching speech to non-verbal children with autism but there is little empirical evidence available regarding the usefulness of picture exchange communication system in managing social and communication issues in autism.
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 4 May 2022.
- Background: PubMed 27679841Thiemann-Bourque K, Brady N, McGuff S, Stump K, Naylor A. Picture Exchange Communication System and Pals: A Peer-Mediated Augmentative and Alternative Communication Intervention for Minimally Verbal Preschoolers With Autism. J Speech Lang Hear Res. 2016 Oct 1;59(5):1133-1145. doi: 10.1044/2016_JSLHR-L-15-0313.
- Background: PubMed 31949163Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.
- Background: PubMed 15449515Ganz JB, Simpson RL. Effects on communicative requesting and speech development of the Picture Exchange Communication System in children with characteristics of autism. J Autism Dev Disord. 2004 Aug;34(4):395-409. doi: 10.1023/b:jadd.0000037416.59095.d7.
- Background: PubMed 28101829Mukherjee SB. Autism Spectrum Disorders - Diagnosis and Management. Indian J Pediatr. 2017 Apr;84(4):307-314. doi: 10.1007/s12098-016-2272-2. Epub 2017 Jan 19.
- 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. This study is not recruiting at the moment.
Nameeka Shahid, PhD* 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 Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorder and PECS Therapy only 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 4 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: finished, as of the sponsor's last update on 4 May 2022. 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?
Portage Early Education Program for Naturalistic Teaching Strategies for children with autism spectrum disorder. (time frame: 30 Sessions (2 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 NCT05359757, 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 4 May 2022.