Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools

June 5, 2023 updated by: Ofer Golan, Bar-Ilan University, Israel

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ramat Gan, Israel, 5290002
        • Bar Ilan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • autism spectrum condition

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group - Autistic children

60 7-10-years-old autistic children, from special education classes integrated in regular schools.

this group will receive EmotiPlay's intervention in the curriculum.

EmotiPlay is 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),
No Intervention: Control group- Autistic children

60 7-10-years-old autistic children, from special education classes integrated in regular schools.

this group will be wait-listed and receive treatment as usual.

No Intervention: Control group-Neurotypical
30 6-10-years-old children, from regular education match in cognitive and linguistic abilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion recognition task
Time Frame: before intervention
Emotion recognition test includes 4 tasks to examine emotion recognition: 1. facial expressions videos 2. decontextualized vocal utterances 3. body language videos 4. Integrative video clips presenting all 3 modalities in context, that were extracted from old television shows, sound track was muffled in order to prevent semantic information, but keep prosodic cues. The test include 12 emotions, for every video or recording 4 answers are presented, the target emotion and the order of the possible answers was counterbalanced. In each modality the subject can achieve 0-12 points, a point for every emotion recognized correctly.
before intervention
Emotion recognition
Time Frame: immediately after the intervention
Emotion recognition test includes 4 tasks to examine emotion recognition: 1. facial expressions videos 2. decontextualized vocal utterances 3. body language videos 4. Integrative video clips presenting all 3 modalities in context, that were extracted from old television shows, sound track was muffled in order to prevent semantic information, but keep prosodic cues. The test include 12 emotions, for every video or recording 4 answers are presented, the target emotion and the order of the possible answers was counterbalanced. In each modality the subject can achieve 0-12 points, a point for every emotion recognized correctly.
immediately after the intervention
Emotion recognition
Time Frame: 15 weeks after the end of the intervention
Emotion recognition test includes 4 tasks to examine emotion recognition: 1. facial expressions videos 2. decontextualized vocal utterances 3. body language videos 4. Integrative video clips presenting all 3 modalities in context, that were extracted from old television shows, sound track was muffled in order to prevent semantic information, but keep prosodic cues. The test include 12 emotions, for every video or recording 4 answers are presented, the target emotion and the order of the possible answers was counterbalanced. In each modality the subject can achieve 0-12 points, a point for every emotion recognized correctly.
15 weeks after the end of the intervention
Emotion understanding
Time Frame: before intervention

TEC - Test of Emotion Competence (Pons & Harris, 2000) design to assess emotion understanding in 3-12 years old children, it is based on Pons et al. (2002) model of 9 developmental stages to emotion understanding among children.

In the test, the subjects are presented with 23 illustrated pictures, in a boy and girl versions. In the first 5 scenarios the child is asked to recognize basic emotions from facial expressions, Next, the child is presented with short stories and the illustrated picture is missing emotional cues in the character face. The examiner reads the story and the child is asked to choose the correct emotion from 4 options. Maximum scoring 21 points.

before intervention
Emotion understanding
Time Frame: immediately after the intervention

TEC - Test of Emotion Competence (Pons & Harris, 2000) design to assess emotion understanding in 3-12 years old children, it is based on Pons et al. (2002) model of 9 developmental stages to emotion understanding among children.

In the test, the subjects are presented with 23 illustrated pictures, in a boy and girl versions. In the first 5 scenarios the child is asked to recognize basic emotions from facial expressions, Next, the child is presented with short stories and the illustrated picture is missing emotional cues in the character face. The examiner reads the story and the child is asked to choose the correct emotion from 4 options. Maximum scoring 21 points.

immediately after the intervention
Emotion understanding
Time Frame: 15 weeks after the end of the intervention

TEC - Test of Emotion Competence (Pons & Harris, 2000) design to assess emotion understanding in 3-12 years old children, it is based on Pons et al. (2002) model of 9 developmental stages to emotion understanding among children.

In the test, the subjects are presented with 23 illustrated pictures, in a boy and girl versions. In the first 5 scenarios the child is asked to recognize basic emotions from facial expressions, Next, the child is presented with short stories and the illustrated picture is missing emotional cues in the character face. The examiner reads the story and the child is asked to choose the correct emotion from 4 options. Maximum scoring 21 points.

15 weeks after the end of the intervention
Emotional-mental vocabulary
Time Frame: before intervention
Emotion definition task - assess the subject's ability to define 12 emotions. Participants were asked to define the emotion (for example: "please explain what is happy?") and to give examples to personalize experience related to each of the emotions (e.g.: "can you describe a situation that you felt happy?"). The definition and examples were audiotaped, and then transcribed. Points will be allocated to the definition of each emotion according the subscale vocabulary in WISC- IV, all emotions falls within the range of 0 to 24 points
before intervention
Emotional-mental vocabulary
Time Frame: immediately after the intervention
Emotion definition task - assess the subject's ability to define 12 emotions. Participants were asked to define the emotion (for example: "please explain what is happy?") and to give examples to personalize experience related to each of the emotions (e.g.: "can you describe a situation that you felt happy?"). The definition and examples were audiotaped, and then transcribed. Points will be allocated to the definition of each emotion according the subscale vocabulary in WISC- IV, all emotions falls within the range of 0 to 24 points
immediately after the intervention
Emotional-mental vocabulary
Time Frame: 15 weeks after the end of the intervention
Emotion definition task - assess the subject's ability to define 12 emotions. Participants were asked to define the emotion (for example: "please explain what is happy?") and to give examples to personalize experience related to each of the emotions (e.g.: "can you describe a situation that you felt happy?"). The definition and examples were audiotaped, and then transcribed. Points will be allocated to the definition of each emotion according the subscale vocabulary in WISC- IV, all emotions falls within the range of 0 to 24 points
15 weeks after the end of the intervention
social functioning
Time Frame: before intervention
socio-emotional functioning will be evaluated by playground observation and coded by POPE - Playground Observation of Peer Engagement (Kasari et al, 2005). This instrument is a time-interval behavior coding system. Independent observers from the research team watched the target child on the playground for 40 consecutive seconds and then coded for 2 seconds for ten minutes during school recess. The observers noted the child's engagement with peers on the playground (solitary, proximity, onlooking, parallel, parallel aware, involved in games and rules and joint engaged with peers) in each interval. Coders will also note positive and negative initiations of the target child towered other children, and positive and negative responses to a peer's social overtures.
before intervention
social functioning
Time Frame: immediately after the intervention
socio-emotional functioning will be evaluated by playground observation and coded by POPE - Playground Observation of Peer Engagement (Kasari et al, 2005). This instrument is a time-interval behavior coding system. Independent observers from the research team watched the target child on the playground for 40 consecutive seconds and then coded for 2 seconds for ten minutes during school recess. The observers noted the child's engagement with peers on the playground (solitary, proximity, onlooking, parallel, parallel aware, involved in games and rules and joint engaged with peers) in each interval. Coders will also note positive and negative initiations of the target child towered other children, and positive and negative responses to a peer's social overtures.
immediately after the intervention
social functioning
Time Frame: 15 weeks after the end of the intervention
socio-emotional functioning will be evaluated by playground observation and coded by POPE - Playground Observation of Peer Engagement (Kasari et al, 2005). This instrument is a time-interval behavior coding system. Independent observers from the research team watched the target child on the playground for 40 consecutive seconds and then coded for 2 seconds for ten minutes during school recess. The observers noted the child's engagement with peers on the playground (solitary, proximity, onlooking, parallel, parallel aware, involved in games and rules and joint engaged with peers) in each interval. Coders will also note positive and negative initiations of the target child towered other children, and positive and negative responses to a peer's social overtures.
15 weeks after the end of the intervention
spontaneous emotional mental language
Time Frame: before intervention

Narrative re-telling task - narratives were elicited using two wordless picture-books, "Frog on His Own (Mayer, 1973) and "Frog, where are you?" (Mayer, 1969). Stories were shortened to a 15-pages, depicting a frog's adventures after departing from his boy companion. Participants are asked to listen to a story the examiner is telling with a predetermined script, while presenting the pictures on an iPad (via book creator app). One book was randomly assigned to each participant, and after listening to the story, the participants will be asked to tell the story in their own words while flipping through the pictures.

The stories will be audiotaped, transcribed and coded according to Capps et al., (2000)

before intervention
spontaneous emotional mental language
Time Frame: immediately after the intervention

Narrative re-telling task - narratives were elicited using two wordless picture-books, "Frog on His Own (Mayer, 1973) and "Frog, where are you?" (Mayer, 1969). Stories were shortened to a 15-pages, depicting a frog's adventures after departing from his boy companion. Participants are asked to listen to a story the examiner is telling with a predetermined script, while presenting the pictures on an iPad (via book creator app). One book was randomly assigned to each participant, and after listening to the story, the participants will be asked to tell the story in their own words while flipping through the pictures.

The stories will be audiotaped, transcribed and coded according to Capps et al., (2000)

immediately after the intervention
spontaneous emotional mental language
Time Frame: 15 weeks after the end of the intervention

Narrative re-telling task - narratives were elicited using two wordless picture-books, "Frog on His Own (Mayer, 1973) and "Frog, where are you?" (Mayer, 1969). Stories were shortened to a 15-pages, depicting a frog's adventures after departing from his boy companion. Participants are asked to listen to a story the examiner is telling with a predetermined script, while presenting the pictures on an iPad (via book creator app). One book was randomly assigned to each participant, and after listening to the story, the participants will be asked to tell the story in their own words while flipping through the pictures.

The stories will be audiotaped, transcribed and coded according to Capps et al., (2000)

15 weeks after the end of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autistic traits
Time Frame: before the intervention

The school-age form (4 to 18 years) of the Social Responsiveness Scale, 2nd edition (SRS-2) (Constantino & Gruber, 2012) to assess severity of autism traits.

The SRS-2 measures social awareness, social communication, social motivation, social cognition and inflexible behaviors applying a dimensional concept of autism. The SRS-2 includes 65 items., each scored on a 4-point Likert scale, from 0 ("not true") to 3 ("almost always true"), yielding a maximum of 195. Out of the 65 items of the SRS-2, 53 focus on social communicative abilities, these items examine the ability to interpret social cues, to maintain social conversation, as well as to initiate social interaction (e.g., "Doesn't recognize when others are trying to take advantage of him or her"). The 12 remaining items probe repetitive behaviors or restricted patterns of interest (e.g., "Shows unusual sensory interests or strange ways of playing with toys").

before the intervention
Autistic traits
Time Frame: immediately after the intervention

The school-age form (4 to 18 years) of the Social Responsiveness Scale, 2nd edition (SRS-2) (Constantino & Gruber, 2012) to assess severity of autism traits.

The SRS-2 measures social awareness, social communication, social motivation, social cognition and inflexible behaviors applying a dimensional concept of autism. The SRS-2 includes 65 items., each scored on a 4-point Likert scale, from 0 ("not true") to 3 ("almost always true"), yielding a maximum of 195. Out of the 65 items of the SRS-2, 53 focus on social communicative abilities, these items examine the ability to interpret social cues, to maintain social conversation, as well as to initiate social interaction (e.g., "Doesn't recognize when others are trying to take advantage of him or her"). The 12 remaining items probe repetitive behaviors or restricted patterns of interest (e.g., "Shows unusual sensory interests or strange ways of playing with toys").

immediately after the intervention
adaptive skills
Time Frame: before the intervention
ABAS-II: Adaptive Behavior Assessment System (Harrison & Oakland, 2003), assessment of the adaptive skills of individuals. This measure evaluates 10 adaptive domains: communication. Functional academics, self-direction. Leisure, social. Community use, home / school living health and safety, self-care and work. ABAS-II was translated to Hebrew and standardized by PsychTech Ltd.
before the intervention
adaptive skills
Time Frame: immediately after the intervention
ABAS-II: Adaptive Behavior Assessment System (Harrison & Oakland, 2003), assessment of the adaptive skills of individuals. This measure evaluates 10 adaptive domains: communication. Functional academics, self-direction. Leisure, social. Community use, home / school living health and safety, self-care and work. ABAS-II was translated to Hebrew and standardized by PsychTech Ltd.
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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