NCT05359757

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

January 8, 2022

Last Update Submit

April 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 Sessions ( 2 Months)

Study Arms (2)

Naturalistic therapeutic techniques and PECS therapy.

EXPERIMENTAL
Other: Effect of Naturalistic Teaching Strategies in Children with autism spectrum disorderOther: PECS Therapy only

PECS therapy Only.

ACTIVE COMPARATOR
Other: PECS Therapy only

Interventions

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

Naturalistic therapeutic techniques and PECS therapy.

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

Naturalistic therapeutic techniques and PECS therapy.PECS therapy Only.

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children already taking speech therapy sessions
  • Children with severe to a profound level.
  • Children with any other disorder along with autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 534000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 27679841BACKGROUND
  • Lord 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.

    PMID: 31949163BACKGROUND
  • Ganz 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.

    PMID: 15449515BACKGROUND
  • Mukherjee 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.

    PMID: 28101829BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nameeka Shahid, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 8, 2022

First Posted

May 4, 2022

Study Start

November 25, 2021

Primary Completion

March 1, 2022

Study Completion

April 10, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations