Emergence of Generative Language

Autism Spectrum Disorder Clinical Trial

Official title:

Instructional Programming to Promote the Emergence of Generative Language in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555241
• Other study ID #: IRB00080641
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: December 2, 2016
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder (ASD)

• Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)

• Speaks primarily in one word utterances

• English as their primary language

• Follows simple 1-step instructions

• Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks

Exclusion Criteria:

• Children with significant problem behavior that interferes with structured intervention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Mand Training
The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
• Matrix
The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
• Stimulus Equivalence Training
The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Length of Utterances (MLU) during manding	The mean length of utterances (MLU) during manding will be evaluated in a 10 minute probe. The goal of intervention is to increase of MLU to an average of 3 words per mand.	Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)	No
Primary	Acquisition of noun-verb and color-shape combinations during tacting	The goal of intervention is mastery of 80% of evaluated noun-verb and color-shape targets.	Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)	No
Primary	Emergence of intraverbal responses	The goal of intervention is the mastery of 80% of evaluated intraverbal responses (2 for each target, 18 total).	Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)	No
Secondary	Change in Macarthur Bates-Communicative Development Inventory (CDI) Score	The Macarthur Bates-Communicative Development Inventory (CDI) is completed by a parent/caregiver and evaluates current word use . A higher score indicates the use of more words.	Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)	No
Secondary	Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).	A goal of the intervention is to observe an increase in spontaneous mands, an increase in spontaneous tacts, as well as an increase in intraverbal responses.	Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)	No