NCT03536351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

May 14, 2018

Last Update Submit

August 18, 2020

Conditions

Keywords

social skillschildtheory of minddramaoccupational therapyspeech-language pathologyneural activation

Outcome Measures

Primary Outcomes (4)

  • Social Skills Improvement Scale

    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.

    4 weeks post intervention

  • Theory of Mind Battery & Inventory

    Performance test of ToM activities and parent ratings of statements of child behavior in ToM situations

    4 weeks post intervention

  • recruitment

    ability to recruit needed number of participants in time frame availability

    pre intervention

  • retention

    number of participants who completed 4 week assessment and parental interview

    4 weeks post- and 3 months post-intervention

Secondary Outcomes (5)

  • Structured Play Assessment

    4 weeks post intervention

  • Brain activity during ToM tasks

    4 weeks post intervention

  • Parental perceptions of social skills

    3 months post intervention

  • Changes in social skills during program

    12 weeks during program

  • modifications needed to program

    12 weeks during program

Study Arms (1)

Interdisciplinary process drama

EXPERIMENTAL

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

Interventions

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.

Interdisciplinary process drama

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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
  • history of developmental delay or neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Autistic DisorderSocial Skills

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Lorie G Richards, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Associate Professor

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

July 1, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations