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Autism Spectrum DisorderNCT03791385

Effectiveness of Picture Exchange Communication System on Gingival Health of Children With Autism Spectrum Disorders

A study testing Picture Exchange Communication System (PECS) in people with Autism Spectrum Disorder, run by Jordan University of Science and Technology at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Picture Exchange Communication System (PECS) is a communication system for children with autism spectrum disorders (ASD). The aim of this study was to assess the effect of a PECS-based tooth-brushing program on gingival health in children with ASD and assess parents' perception of PECS. Read more about this study

Who is it for?
Ages 4 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Picture Exchange Communication System (PECS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteJordan
Study dates
Apr 2011to Oct 2011
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 4 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Children diagnosed with ASD.
  • Age between 4 and 18 years old.

Who cannot join

  • Children unable to cooperate for data collection (poor behavior during dental examination).

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Jordan University of Science and Technology

    Irbid, 22110

Other trials in Jordan

About this study

Official title: Effectiveness of Picture Exchange Communication System (PECS) on Dental Plaque and Gingival Health of Children With Autism

The Picture Exchange Communication System (PECS) is a communication system for children with autism spectrum disorders (ASD). The aim of this study was to assess the effect of a PECS-based tooth-brushing program on gingival health in children with ASD and assess parents' perception of PECS. This was a prospective interventional study. Using PECS as a pictures/cards series showing a structured tooth-brushing method, 37 children with ASD (31 males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two weeks apart. Data collected after examinations (baseline, 3, 6-months) included gingival and plaque indices (GI, PI) and two questionnaires (baseline, 6-months) for demographic data and parents' perception of PECS including: difficulty rating (easy, hard, very hard) and PECS usefulness.

Read the detailed description

The need for improved oral hygiene routines in individuals with autism spectrum disorders (ASD) has been documented in many reports. The Picture Exchange Communication System (PECS), which is a series of pictures that show a structured method and technique for teeth brushing, was chosen for this study since it is a proven communication system for children with autism spectrum disorders (ASD).

The aim of the study was to assess the effect of a PECS-based tooth-brushing program on gingival health in children with ASD and assess parents' perception of PECS.

This was a prospective interventional study. Using PECS as a pictures/cards series showing a structured tooth-brushing method, 37 children with ASD (31 males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two weeks apart. The pictures were placed in the bathroom, at home and/or at the autism center. Data collected after examinations (baseline, 3, 6-months) included gingival and plaque indices (GI, PI) and two questionnaires (baseline, 6-months) for demographic data and parents' perception of PECS including: difficulty rating (easy, hard, very hard) and whether they found PECS useful in teaching their children how to brush their teeth (yes or no).

Being tested
Picture Exchange Communication System (PECS)
Keywords
Autism Spectrum Disorder, Picture Exchange Communication System (PECS), Tooth-brushing program, Gingival index, Plaque index
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.

  • Picture Exchange Communication System (PECS)Behavioural

    A communication system frequently used with non-verbal children with autism spectrum disorders (ASD) that uses a series of pictures that describe how a certain activity is done, in our case showing a structured method and technique for teeth brushing.

Study groups in NCT03791385
Study groupRoleWhat they receive
Study subjectsExperimentalChildren with ASD and their parents/caregivers were trained on tooth-brushing twice, two weeks apart using Picture Exchange Communication System (PECS) PECS as a pictures/cards series showing a structured tooth-brushing method.
Receives: Behavioral: Picture Exchange Communication System (PECS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gingival index score

    This score indicates the level of gingival inflammation upon examination of teeth, reported as the average score calculated as (total score for all teeth/number of examined teeth): Score 0 (Absence of inflammation), Score 1 (Mild inflammation: slight change in colour (more red) and little change in texture (loss of stippling), No bleeding on probing), Score 2 (Moderate inflammation: moderate glazing, redness, edema and hypertrophy; bleeding on probing), Score 3 (Severe inflammation: marked redness and edema; tendency to spontaneous bleeding; ulceration). A lower score indicates less gingival inflammation (better gingival health) and vice versa.

    Measured: 6 months

  2. Plaque index score

    This score indicates the level of plaque (and reflects level of oral hygiene) upon examination of teeth, reported as the average score, calculated as (total score for all teeth/number of examined teeth): Score 0 (No plaque), Score 1 (Plaque not visible by eye, only detectable using a dental probe), Score 2 (Plaque visible by eye \& detectable with a dental probe along the gingival margin of the tooth), Score 4 (Thick layer of plaque visible by eye \& detectable by probe covering more than the gingival margin of the tooth). A lower score indicates less plaque (meaning better oral hygiene) and vice versa.

    Measured: 6 months

Secondary outcomes (2)

  1. Parents' rating of PECS difficulty

    Parents were asked to rate PECS difficulty as: easy, hard, very hard. This was assessed through a questionnaire.

    Measured: 6 months

  2. PECS usefulness

    Parents were asked whether PECS was useful in teaching their children how to brush their teeth: yes, no. This was assessed through a questionnaire.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study startApr 2011
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Children with ASD ages 4-16 years
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791385
Sponsor's protocol ID
20110011
Status last verified
Dec 2018
First submitted
23 Dec 2018
Last updated
2 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pilebro C, Backman B. Teaching oral hygiene to children with autism. Int J Paediatr Dent. 2005 Jan;15(1):1-9. doi: 10.1111/j.1365-263X.2005.00589.x.

    PubMed 15663439

  • Charlop-Christy MH, Carpenter M, Le L, LeBlanc LA, Kellet K. Using the picture exchange communication system (PECS) with children with autism: assessment of PECS acquisition, speech, social-communicative behavior, and problem behavior. J Appl Behav Anal. 2002 Fall;35(3):213-31. doi: 10.1901/jaba.2002.35-213.

    PubMed 12365736

  • Lerna A, Esposito D, Conson M, Massagli A. Long-term effects of PECS on social-communicative skills of children with autism spectrum disorders: a follow-up study. Int J Lang Commun Disord. 2014 Jul-Aug;49(4):478-85. doi: 10.1111/1460-6984.12079. Epub 2014 Mar 21.

    PubMed 24655345

  • Eslami N, Movahed T, Asadi M. Parents' Perceptions of the Oral Health-related Quality of Life of their Autistic Children in Iran. J Clin Pediatr Dent. 2018;42(6):422-426. doi: 10.17796/1053-4625-42.6.3. Epub 2018 Aug 7.

    PubMed 30085870

Questions about this trial

What is this clinical trial studying?

A study testing Picture Exchange Communication System (PECS) in people with Autism Spectrum Disorder, run by Jordan University of Science and Technology at 1 site in Jordan.

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 1 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 2 Jan 2019. 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 Jordan. 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?

Gingival index score (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 NCT03791385, 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 2 Jan 2019.

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