Autism Spectrum DisorderNCT05902832
Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools
A study testing EmotiPlay in people with Autism Spectrum Disorder and Intellectual Disability, Mild, run by Bar-Ilan University, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability, Mild
- What is being tested?
- EmotiPlay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2022to 1 Dec 2023
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- autism spectrum condition
Who cannot join
- Verbal Intelligence (according to Wechsler) 3 or lower.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- EmotiPlay
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmotiPlayBehavioural
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),
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - Autistic children | Experimental | 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. Receives: Behavioral: EmotiPlay |
| Control group- Autistic children | No intervention | 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. |
| Control group-Neurotypical | No intervention | 30 6-10-years-old children, from regular education match in cognitive and linguistic abilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before intervention
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.
Measured: immediately after the intervention
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.
Measured: 15 weeks after the end of the intervention
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.
Measured: before intervention
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.
Measured: immediately after the intervention
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.
Measured: 15 weeks after the end of the intervention
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
Measured: before intervention
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
Measured: immediately after the intervention
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
Measured: 15 weeks after the end of the intervention
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.
Measured: before intervention
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.
Measured: immediately after the intervention
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.
Measured: 15 weeks after the end of the intervention
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)
Measured: before intervention
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)
Measured: immediately after the intervention
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)
Measured: 15 weeks after the end of the intervention
Secondary outcomes (4)
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").
Measured: before the intervention
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").
Measured: immediately after the intervention
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.
Measured: before the intervention
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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Mar 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ofer Golan, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902832
- Sponsor's protocol ID
- Bar Ilan University
- Status last verified
- Jun 2023
- First submitted
- 9 Feb 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28018573Golan 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.
PubMed 18311514Macrostructure, 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Mediated Intervention to Enhance Emotional Competence in Children With Autism in Schools
- ClinicalTrials.gov ID
- NCT05902832
- Acronym / sponsor ID
- Bar Ilan University
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental group - Autistic children | Experimental | Behavioral: EmotiPlay60 7-10-years-old autistic children, from special education classes integrated in regular schools. this group will receive EmotiPlay's intervention in the curriculum. |
| Control group- Autistic children | No intervention | –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. |
| Control group-Neurotypical | No intervention | –30 6-10-years-old children, from regular education match in cognitive and linguistic abilities. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- autism spectrum condition
Key exclusion criteria (1 listed)
- Verbal Intelligence (according to Wechsler) 3 or lower.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmotiPlayEmotiPlay 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), | Behavioural | Experimental group - Autistic children |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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
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
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.
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.
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.
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)
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)
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)
4 secondary outcomes
Autistic traits
Time frame: before the intervention
Autistic traits
Time frame: immediately after the intervention
adaptive skills
Time frame: before the intervention
adaptive skills
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 28018573Fridenson-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.
- Results publication: PubMed 18311514Golan 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.
- Results publicationMacrostructure, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmotiPlay in people with Autism Spectrum Disorder and Intellectual Disability, Mild, run by Bar-Ilan University, Israel at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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 Israel. 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?
Results are not available in the source record.
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?
Emotion recognition task (time frame: before intervention). The study lists 15 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 NCT05902832, which also lists 3 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 15 Jun 2023.