Social Skills in Children With ASD and Process Drama
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interdisciplinary process drama
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring social skills, child, theory of mind, drama, occupational therapy, Speech-language pathology
Eligibility Criteria
Inclusion Criteria: Participants with ASD:
- aged 3-4 years old
- documented diagnosis of ASD from a licensed professional using DSM 5 criteria12; If no documentation available, meets cut off on Autism Diagnostic Observation Scale (ADOS -2)13 that will be administered by trained study staff.
- passes language and cognitive screen (see attached screening document with decision rules) and a receptive language age equivalence of ≥18 months and a non-verbal age equivalent score of ≥24 months on the Mullen Scale of Early Learning14
- have a caregiver willing/able to bring them to the University for the study sessions and to schedule up to 3 assessment visits prior to intervention start and 3 assessment sessions after intervention end
- family's primary language is English
Typically developing children
- aged 3-4
- normal or corrected to normal vision and hearing
- English speaking
Exclusion Criteria: Participants with ASD
- have no other major medical conditions (i.e., no genetic disorders such as Fragile X, Down syndrome)
- seizure disorder
- uncorrected hearing or visual impairment
- other condition causing motor impairment, such as Cerebal Palsy
Typically developing children
-no history of developmental delay or neurological disorder
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interdisciplinary Process drama
Arm Description
Process drama program (5 days/week, 1 week, 25-3 hour sessions) of movement-based activities combining music, art, and drama. Activities have been planned by a collaborative team of drama teachers, occupational therapists, and speech language pathologists.
Outcomes
Primary Outcome Measures
Social Skills Improvement Scale
Child primary outcome: Parent rating of statements about child's social interactions
Theory of Mind Battery and Inventory
Child primary outcome: performance test of theory of mind activities and parent ratings of statements of child behavior in theory of mind situations
Structured Play Assessment
Performance test of how child plays with toys
Retention Rate
Feasibility outcome: number of participants who completed 4 week assessments and 3 month parent interview
Recruitment
ability to recruit needed number of participants in time frame availability
Secondary Outcome Measures
Brain activity during Theory of Mind tasks
Dense EEG recordings of brain activity in frontal/temporal/and parietal lobes during TOM tasks
Parental perceptions of social skills
Interview with parent regarding changes seen in social skills
Changes in social skills during program
observations (via video recording) of social skills during intervention program
Modifications needed to program
record of modifications made during the intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02850666
Brief Title
Social Skills in Children With ASD and Process Drama
Official Title
Building Social Skills in Children With ASD Characteristics Through Process Drama
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a one-group, pre-post feasibility study of an intensive, interdisciplinary (theatre, Occupational Therapy (OT), and Speech Language Pathology (SLP)) intervention targeted at social skill development in children, aged 3-4. The intervention uses process drama modified with OT and SLP techniques and using typically developing peer models. Feasibility outcomes are recruitment rates, retention rates, daily program records of ease of implementing program, and record of modifications needed. Child primary outcomes are Social Skills Improvement Scale (SSIS), Theory of Mind (T0M) Battery and Inventory, Structured Play Assessment (SPA), and Communication and Symbolic Behavior Scales (CSBS) scores within 4 weeks of program end. Secondary outcomes are brain activity in frontal lobe and temporal/parietal areas measured by high density EEG within 4 weeks of program end, parental interview at 3 months related to child's social skills, and observational data on social skills during the program.
Detailed Description
Six children with Autism Spectrum Disorder (ASD) and 6 typically developing (TD) preschool children participate will complete baseline testing. The TD children will only complete the EEG testing, while the ASD children and their parents will complete all outcome assessments. In addition to the outcome measures listed in the Brief Summary, the children we will administer the the Vineland Adaptive Behavioral Scales (Vineland - II), the Mullen Scales of Early Learning, and the Autism Diagnostic Observation Scale - II (if they have not had one administered within the past 12 months) for sample description.
During the EEG session, brain activity during theory of mind and other social stimuli will be used to measure brain behavior relationships. The recordings will adhere to standard clinical EEG procedures, using high density EEG providing a high spatial resolution for electrical source imaging in brain space. They will be conducted by a Registered EEG Technologist (R. EEG T) with a specially trained student assistant. The procedure will involve first explaining to the parent and child what will be done. The participants will sit within a chair or a parent's lap while the EEG is recorded. The EEG tasks will consist of the following: First the child will be asked to open and close their eyes for a few minutes to record a baseline resting EEG. Then there will be both auditory sounds (intonations and word components) and images of social stimuli embedded between fun cartoon stimuli to maintain the child's attention displayed on a screen. The pictures will consist of eye movements, facial gestures, and point light diagrams of body movements.
The process drama program will be conducted with 6 children with ASD and 6 TD peer models 5 days per week for 1 week for 2.5-3 hours each day. The program will consist of several sections. Each day will open with an opening ritual that is movement based involving mirroring activity. This is followed by a welcome/greeting activity, involving things like a song and Name activity. The remainder of the activities build around a story for the day. The story will be one that holds interest for young children, such as a day in the life of a tree who gets visited by animals and people. The story unfolds with problems to solve and social interactions to do. Participants and the drama teachers take on different roles to bring out the story. Engagement starts out with drama pieces that the children can do individually and progress to those requiring a partner and then small groups. Other artistic experiences related to the story are included in the session, such as music and movement related to the story and an art activity related to the story. The sessions close with a closing ritual, reminding the participants of what was done during the session and a song. All the activities focus on building understanding the emotions and intentions of others and appropriate social interactions. The setting of the program and the specific activities have been planned with a collaborative team of drama teachers, an occupational therapists, and a speech language pathologists.
The process drama sessions will be videotaped and later scored for social interactions and social verbal and non-verbal communication. We will also examine the engagement of the participants with ASD to determine if we need to change/alter any procedures/techniques that we are using during the process drama sessions in subsequent versions of this research. We will also examine the behavior of the peer models to identify areas in which the research team may need to change to better engage the peer models in subsequent sessions.
After the end of the process drama intervention, the participants with ASD will repeat the baseline assessments within 4 weeks of intervention end. The assessments that will be repeated are the ToMT, CSBS, SPA and SSiS. The children with ASD will also complete another EEG session as they did at baseline.
Three months after the last testing session, the parents will be contacted to complete an interview to ask how their children are functioning related to play and other interactions with other children and with adults. These interviews may occur face-to-face at a mutually agreed upon location, could be over the phone, or could be via a video conferencing system, such as Business Skype. The interviews will be audio-recorded for later thematic analysis. After these themes are identified, the parents will be re-contacted and shown the identified themes to make sure that we have accurately represented what they intended to convey (member checking).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
social skills, child, theory of mind, drama, occupational therapy, Speech-language pathology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interdisciplinary Process drama
Arm Type
Experimental
Arm Description
Process drama program (5 days/week, 1 week, 25-3 hour sessions) of movement-based activities combining music, art, and drama. Activities have been planned by a collaborative team of drama teachers, occupational therapists, and speech language pathologists.
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary process drama
Intervention Description
Process drama program (5 days/week, 1 week, 25-3 hour sessions) of movement-based activities combining music, art, and drama. Activities have been planned by a collaborative team of drama teachers, occupational therapists, and speech language pathologists.
Primary Outcome Measure Information:
Title
Social Skills Improvement Scale
Description
Child primary outcome: Parent rating of statements about child's social interactions
Time Frame
4 weeks post intervention
Title
Theory of Mind Battery and Inventory
Description
Child primary outcome: performance test of theory of mind activities and parent ratings of statements of child behavior in theory of mind situations
Time Frame
4 weeks post intervention
Title
Structured Play Assessment
Description
Performance test of how child plays with toys
Time Frame
4 weeks after intervention
Title
Retention Rate
Description
Feasibility outcome: number of participants who completed 4 week assessments and 3 month parent interview
Time Frame
3 months after intervenrtion
Title
Recruitment
Description
ability to recruit needed number of participants in time frame availability
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Brain activity during Theory of Mind tasks
Description
Dense EEG recordings of brain activity in frontal/temporal/and parietal lobes during TOM tasks
Time Frame
4 weeks after intervention
Title
Parental perceptions of social skills
Description
Interview with parent regarding changes seen in social skills
Time Frame
3 months
Title
Changes in social skills during program
Description
observations (via video recording) of social skills during intervention program
Time Frame
1 week
Title
Modifications needed to program
Description
record of modifications made during the intervention
Time Frame
at 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants with ASD:
aged 3-4 years old
documented diagnosis of ASD from a licensed professional using DSM 5 criteria12; If no documentation available, meets cut off on Autism Diagnostic Observation Scale (ADOS -2)13 that will be administered by trained study staff.
passes language and cognitive screen (see attached screening document with decision rules) and a receptive language age equivalence of ≥18 months and a non-verbal age equivalent score of ≥24 months on the Mullen Scale of Early Learning14
have a caregiver willing/able to bring them to the University for the study sessions and to schedule up to 3 assessment visits prior to intervention start and 3 assessment sessions after intervention end
family's primary language is English
Typically developing children
aged 3-4
normal or corrected to normal vision and hearing
English speaking
Exclusion Criteria: Participants with ASD
have no other major medical conditions (i.e., no genetic disorders such as Fragile X, Down syndrome)
seizure disorder
uncorrected hearing or visual impairment
other condition causing motor impairment, such as Cerebal Palsy
Typically developing children
-no history of developmental delay or neurological disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorie G Richards, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15701223
Citation
Pelphrey KA, Morris JP, McCarthy G. Grasping the intentions of others: the perceived intentionality of an action influences activity in the superior temporal sulcus during social perception. J Cogn Neurosci. 2004 Dec;16(10):1706-16. doi: 10.1162/0898929042947900.
Results Reference
background
PubMed Identifier
25845529
Citation
Thomas MS, Davis R, Karmiloff-Smith A, Knowland VC, Charman T. The over-pruning hypothesis of autism. Dev Sci. 2016 Mar;19(2):284-305. doi: 10.1111/desc.12303. Epub 2015 Apr 6.
Results Reference
background
PubMed Identifier
26419766
Citation
Corbett BA, Key AP, Qualls L, Fecteau S, Newsom C, Coke C, Yoder P. Improvement in Social Competence Using a Randomized Trial of a Theatre Intervention for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Feb;46(2):658-72. doi: 10.1007/s10803-015-2600-9.
Results Reference
result
Learn more about this trial
Social Skills in Children With ASD and Process Drama
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