NCT03791385

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

December 23, 2018

Last Update Submit

December 29, 2018

Conditions

Keywords

Autism Spectrum DisorderPicture Exchange Communication System (PECS)Tooth-brushing programGingival indexPlaque index

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months

  • 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.

    6 months

Secondary Outcomes (2)

  • Parents' rating of PECS difficulty

    6 months

  • PECS usefulness

    6 months

Study Arms (1)

Study subjects

EXPERIMENTAL

Children 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.

Behavioral: Picture Exchange Communication System (PECS)

Interventions

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 subjects

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (4)

  • 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.

    PMID: 15663439BACKGROUND
  • 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.

    PMID: 12365736BACKGROUND
  • 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.

    PMID: 24655345BACKGROUND
  • 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.

    PMID: 30085870BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ola B Al-Batayneh

    Jordan University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Children with ASD ages 4-16 years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2018

First Posted

January 2, 2019

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 2, 2019

Record last verified: 2018-12

Locations