NCT02850666

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

July 26, 2016

Last Update Submit

May 14, 2018

Conditions

Autistic Disorder

Keywords

social skillschildtheory of minddramaoccupational therapySpeech-language pathology

Outcome Measures

Primary Outcomes (5)

  • Social Skills Improvement Scale

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

    4 weeks post intervention

  • 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

    4 weeks post intervention

  • Structured Play Assessment

    Performance test of how child plays with toys

    4 weeks after intervention

  • Retention Rate

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

    3 months after intervenrtion

  • Recruitment

    ability to recruit needed number of participants in time frame availability

    at baseline

Secondary Outcomes (4)

  • Brain activity during Theory of Mind tasks

    4 weeks after intervention

  • Parental perceptions of social skills

    3 months

  • Changes in social skills during program

    1 week

  • Modifications needed to program

    at 1 week

Study Arms (1)

Interdisciplinary Process drama

EXPERIMENTAL

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.

Behavioral: Interdisciplinary process drama

Interventions

Interdisciplinary process dramaBEHAVIORAL

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.

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 ≥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

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 Cerebal Palsy
  • Typically developing children
  • no 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)

  • 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.

    PMID: 15701223BACKGROUND

  • 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.

    PMID: 25845529BACKGROUND

  • 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.

    PMID: 26419766RESULT

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Associate Professor

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

September 12, 2017

Study Completion

October 1, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)