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Building Social Skills With Interdisciplinary Process Drama in ASD

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ClinicalTrials.gov Identifier: NCT03536351
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Lorie Richards, University of Utah

Brief Summary:
This is a one group pre-post feasibility study of an 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 the program, and record of modifications needed. Child primary outcomes are Social Skills Improvement Scale (SSIS) and the Theory of Mind (ToM) Battery and Inventory within 4 weeks of program end. Secondary outcomes will be the Structured Play Assessment (SPA) within 4 weeks post-intervention, observations of social interactions (e.g.,eye contract, joint attention, verbal utterances, physical contact) during intervention sessions, brain activity in frontal and temporal/parietal areas during ToM tasks measured by high density EEG within 4 weeks of program end, and parental interview at 3 months related to child's social skills.

Condition or disease Intervention/treatment Phase
Autistic Disorder Behavioral: Interdisciplinary process drama Not Applicable

Detailed Description:

Five children with Autism Spectrum Disorder (ASD) and 3-5 typically developing (TD) children 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, we will administer 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 5 children with ASD and 3-5 TD peer models 3 days per week for 12 week for 1-1.5 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. 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 taped 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, SPA and SSiS. The children with ASD will also complete another EEG session as they did at baseline. Parents will be interviewed at 3 months post-intervention regarding changes in social skills.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: One group design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Building Social Skills With Interdisciplinary Drama With Children With Autism Spectrum Disorder
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interdisciplinary process drama
Process drama program (3 days/week, 12 weeks, 1-1.5 hours per session) of movement-based activities combining music and drama. Activities have been planned by a collaborative team of drama teachers, occupational therapists, and speech language pathologists, and target understanding emotion, intentions and appropriate social interactions.
Behavioral: Interdisciplinary process drama
Process drama program (3 days/week, 12 weeks, 1-1.5 hours per session) of movement-based activities combining music and drama. Activities that target understanding of emotions, intentions, and appropriate social interactions have been planned by a team of drama teachers, occupational therapists, and speech-language pathologists.




Primary Outcome Measures :
  1. Social Skills Improvement Scale [ Time Frame: 4 weeks post intervention ]
    Parent rating of statements about child's social interactions as never, seldom, often, almost always. These are transformed to numeric scores, varying with the content of the item, either ranging from 0-3 or 1-3. Each subscale has a different number of items. Subscales of communication, cooperation, assertion, responsibility, empathy, engagement, self-control scores, externalizing problem behaviors, bullying, hyperactivity/inattention, and internalizing problem behaviors items are summed to obtain subscale raw scores, which are translated into "below average", "average", and "above average", based on age and gender normative data. The autism spectrum subscale is scored the same way.

  2. Theory of Mind Battery & Inventory [ Time Frame: 4 weeks post intervention ]
    Performance test of ToM activities and parent ratings of statements of child behavior in ToM situations

  3. recruitment [ Time Frame: pre intervention ]
    ability to recruit needed number of participants in time frame availability

  4. retention [ Time Frame: 4 weeks post- and 3 months post-intervention ]
    number of participants who completed 4 week assessment and parental interview


Secondary Outcome Measures :
  1. Structured Play Assessment [ Time Frame: 4 weeks post intervention ]
    performance test of how child plays with toys

  2. Brain activity during ToM tasks [ Time Frame: 4 weeks post intervention ]
    Dense EEG recordings of brain activity in front/temporal/parietal areas during ToM tasks

  3. Parental perceptions of social skills [ Time Frame: 3 months post intervention ]
    interview with parent regarding changes seen in social skills

  4. Changes in social skills during program [ Time Frame: 12 weeks during program ]
    observations (via digital recordings) of social skills during intervention program

  5. modifications needed to program [ Time Frame: 12 weeks during program ]
    record of modifications to the program during the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: for children 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 ≥30 months and a non-verbal age equivalent score of ≥30 months on the Mullen Scale of Early Learning
  • 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

INCLUSION for TD children:

  • aged 3-4
  • normal or corrected to normal vision and hearing
  • English speaking

Exclusion Criteria: for children 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 Cerebral Palsy

Exclusion for TD children:

  • history of developmental delay or neurological disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536351


Contacts
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Contact: Lorie G Richards, PhD 801-585-1069 lorie.richards@hsc.utah.edu
Contact: Xan Johnson, PhD 801-581-4927 Xan.S.Johnson@utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Megan Raby, MS    612-325-9802    Megan.Raby@health.utah.edu   
Contact: Lorie G Richards, PhD    801-585-1069    lorie.richards@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Lorie G Richards, PhD University of Utah

Publications of Results:
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Responsible Party: Lorie Richards, Chair and Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03536351     History of Changes
Other Study ID Numbers: IRB_0091961
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorie Richards, University of Utah:
social skills
child
theory of mind
drama
occupational therapy
speech-language pathology
neural activation
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders