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Completed

NCT Number: NCT02276534

SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Kennedy Center

Nashville, Tennessee, 37203, United States

About this study

The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.

Objectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children diagnosed with autism spectrum disorder with IQ ≥ to 70.

Exclusion criteria

  • IQ ≤ 70, children with current aggression toward self or others.

Treatment and study plan

SENSE Theatre

Behavioral

A peer-mediated, theatre-based intervention.

Delayed Intervention

Behavioral

Primary outcomes

  1. NEPSY Memory for faces

    Time frame: Change from Baseline at Week 10 and Week 16

    The measure requires the child to observe 16 faces of children and then remember them immediately and following a 30-minute delay. Raw scores are generated which are converted to standardized scores based on normative data.

  2. Measurement of Salivary Cortisol levels

    Time frame: Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes

  3. Event Related Potentials (ERP) incidental memory task

    Time frame: Change from baseline at Week 10 and Week 16

  4. Social Responsiveness Scale

    Time frame: Change from baseline at Week 10 and Week 16

  5. Peer Interaction Playground Paradigm

    Time frame: Change from baseline at Week 10 and Week 16

    A playground play session conducted with trained typically developing peers.

  6. Adaptive Behavior Assessment System

    Time frame: Change from baseline at Week 10 and Week 16

    Parent questionnaire of child's adaptive behavior

  7. Parenting Stress Index

    Time frame: Change from baseline at Week 10 and Week 16

    parent-based questionnaire

Secondary outcomes

  1. Clinical Evaluation of Fundamentals Recalling Sentences subtest

    Time frame: Change from baseline at Week 10 and Week 16

  2. Peabody Picture Vocabulary Test

    Time frame: Change from baseline at Week 10 and Week 16

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

SENSE Theatre Research Program

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2014
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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