Clinical trial NCT05902832: Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools
Official title: Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Intellectual Disability, Mild
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participant will be randomly divided to one of two groups: first group will take part in the intervention program and the second will be wait-listed and children will receive treatment as usual
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autism spectrum condition (ASC) is a neurodevelopmental disorder characterized fundamentally by social deficits. Emotional competence - the ability to express, recognize, understand, and regulate emotions - is a key aspect of social communication. Evidence suggests that the developmental trajectories of autistic children differ from that of neuro-typical children regarding their ability to process and recognize emotions from paralinguistic emotional facial, body language, and voice tone cues. They also have difficulty integrating these cues in context and lack in emotional language.

Numerous approaches to teaching people with autism how to recognize and understand emotions have been tried, with recent increased interest in computer-based interventions (CBI). However, most of the research focused only on facial expressions, were limited to autistic children with no intellectual disabilities (ID); and showed limited generalization to real social settings. EmotiPlay, a computer-based intervention program, designed to enhance emotion recognition (ER) by addressing multiple modalities of emotional cues (facial expressions, tone of voice, body language), has shown good outcome when used at home by autistic children and no ID . However, the examination of generalization was partial and depended only on parental reports.

The present study main goals are to: (1) Examine the adaptation and the integration of EmotiPlay into special education classrooms in regular schools. (2) Assess EmotiPlay's effect on emotional competence among autistic children at different functioning levels.

Detailed description: This research is comprised of two main stages:

the first stage is a Pilot, who's main goals are to examine the adaptation and integration of EmotiPlay's intervention to a school setting with autistic children at various ages and levels of functioning, and to test an extended EC battery for EmotiPlay's evaluation.

The pilot includes 5 special education classes that will take part at a short version of the intervention program, and a control group of neurotypical children matched in intellectual and linguistic abilities.

the second stage will include 150 participants, divided into three groups: 60 7-10-year-old autistic children who will participate in the intervention program; 60 7-10-year-old autistic children who will not participate in the intervention; and 30 neuro-typical children matched in cognitive and linguistic skills.

All participant will undergo a pre-assessment tests that include: (1) multi-modal basic and complex ER (2) emotion understanding based on a standardized measure (the Test of Emotion Comprehension - TEC) (3) an emotion definition task (4) a story- telling task (5) an observation of children's prosocial behavior during free-playtime (using the Playground Observation of Peer Engagement - POPE). After evaluations participants will be randomly divided into two groups, the first group will take part in the intervention program and the second will be the control group.

EmotiPlay's intervention program will be administered by a certified educational staff for 18 weeks (36 lessons).

All participant will be evaluated immediately after the intervention; and 15 weeks post-intervention.

The important contribution of this study is twofold. It integrates an intervention program to promote emotional competence into the educational system, which serves as a major platform for acquiring social skills. Concurrently, it offers a way to assess the social functioning in real life situations of children with autism at different levels of functioning.

Eligibility criteria: Inclusion Criteria:

* autism spectrum condition

Exclusion Criteria:

* Verbal Intelligence (according to Wechsler) 3 or lower.

Primary outcomes:
measure: Emotion recognition task
timeFrame: before intervention
measure: Emotion recognition
timeFrame: immediately after the intervention
measure: Emotion recognition
timeFrame: 15 weeks after the end of the intervention
measure: Emotion understanding
timeFrame: before intervention
measure: Emotion understanding
timeFrame: immediately after the intervention
measure: Emotion understanding
timeFrame: 15 weeks after the end of the intervention
measure: Emotional-mental vocabulary
timeFrame: before intervention
measure: Emotional-mental vocabulary
timeFrame: immediately after the intervention
measure: Emotional-mental vocabulary
timeFrame: 15 weeks after the end of the intervention
measure: social functioning
timeFrame: before intervention
measure: social functioning
timeFrame: immediately after the intervention
measure: social functioning
timeFrame: 15 weeks after the end of the intervention
measure: spontaneous emotional mental language
timeFrame: before intervention
measure: spontaneous emotional mental language
timeFrame: immediately after the intervention
measure: spontaneous emotional mental language
timeFrame: 15 weeks after the end of the intervention
Secondary outcomes:
measure: Autistic traits
timeFrame: before the intervention
measure: Autistic traits
timeFrame: immediately after the intervention
measure: adaptive skills
timeFrame: before the intervention
measure: adaptive skills
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Bar Ilan University
Study officials:
References:
citation: Fridenson-Hayo S, Berggren S, Lassalle A, Tal S, Pigat D, Bolte S, Baron-Cohen S, Golan O. Basic and complex emotion recognition in children with autism: cross-cultural findings. Mol Autism. 2016 Dec 19;7:52. doi: 10.1186/s13229-016-0113-9. eCollection 2016.
citation: Golan O, Baron-Cohen S, Golan Y. The 'Reading the Mind in Films' Task [child version]: complex emotion and mental state recognition in children with and without autism spectrum conditions. J Autism Dev Disord. 2008 Sep;38(8):1534-41. doi: 10.1007/s10803-007-0533-7. Epub 2008 Feb 29.
citation: Macrostructure, microstructure, and mental state terms in the narratives of English-Hebrew bilingual preschool children with and without specific language impairment. Applied PsychoLinguistics, 37(1), 165-193.