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Autistic DisorderNCT02850666

Social Skills in Children With ASD and Process Drama

A study testing Interdisciplinary process drama in people with Autistic Disorder, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 4 yearsHealthy volunteers can take part
Conditions the study is for
Autistic Disorder
What is being tested?
Interdisciplinary process drama
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Jul 2016to 1 Oct 2017
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 3 to 4 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 9Show fewer
  • aged 3-4
  • normal or corrected to normal vision and hearing
  • English speaking

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Building Social Skills in Children With ASD Characteristics Through Process Drama

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.

Read the 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).

Being tested
Interdisciplinary process drama
Keywords
social skills, child, theory of mind, drama, occupational therapy, Speech-language pathology
Medical subject headings
Autistic Disorder, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interdisciplinary process dramaBehavioural

    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.

Study groups in NCT02850666
Study groupRoleWhat they receive
Interdisciplinary Process dramaExperimentalProcess 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.
Receives: Behavioral: Interdisciplinary process drama

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Skills Improvement Scale

    Child primary outcome: Parent rating of statements about child's social interactions

    Measured: 4 weeks post intervention

  2. 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

    Measured: 4 weeks post intervention

  3. Structured Play Assessment

    Performance test of how child plays with toys

    Measured: 4 weeks after intervention

  4. Retention Rate

    Feasibility outcome: number of participants who completed 4 week assessments and 3 month parent interview

    Measured: 3 months after intervenrtion

  5. Recruitment

    ability to recruit needed number of participants in time frame availability

    Measured: at baseline

Secondary outcomes (4)
  1. Brain activity during Theory of Mind tasks

    Dense EEG recordings of brain activity in frontal/temporal/and parietal lobes during TOM tasks

    Measured: 4 weeks after intervention

  2. Parental perceptions of social skills

    Interview with parent regarding changes seen in social skills

    Measured: 3 months

  3. Changes in social skills during program

    observations (via video recording) of social skills during intervention program

    Measured: 1 week

  4. Modifications needed to program

    record of modifications made during the intervention

    Measured: at 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion12 Sep 2017
  4. Study completion1 Oct 2017

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02850666
Sponsor's protocol ID
IRB_00091961
Status last verified
May 2018
First submitted
26 Jul 2016
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15701223
  • 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.

    PubMed 25845529
  • 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.

    PubMed 26419766

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary process drama in people with Autistic Disorder, run by University of Utah at 1 site in United States.

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 9 inclusion and 6 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: finished, as of the sponsor's last update on 15 May 2018. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Social Skills Improvement Scale (time frame: 4 weeks post intervention). The study lists 5 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 NCT02850666, 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 May 2018.

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