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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05902832
• Other study ID #: Bar Ilan University
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2023
• Source: Bar-Ilan University, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• autism spectrum condition

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Intellectual Disability

Intervention

Behavioral:
• EmotiPlay
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),

Locations

Country	Name	City	State
Israel	Bar Ilan University	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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 20 — View 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/s10803-0 — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion recognition task	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
Primary	Emotion recognition	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
Primary	Emotion recognition	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
Primary	Emotion understanding	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
Primary	Emotion understanding	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
Primary	Emotion understanding	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
Primary	Emotional-mental vocabulary	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
Primary	Emotional-mental vocabulary	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
Primary	Emotional-mental vocabulary	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
Primary	social functioning	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
Primary	social functioning	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
Primary	social functioning	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
Primary	spontaneous emotional mental language	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
Primary	spontaneous emotional mental language	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
Primary	spontaneous emotional mental language	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	Autistic traits	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
Secondary	Autistic traits	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
Secondary	adaptive skills	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
Secondary	adaptive skills	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