Emergence of Generative Language

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Mand Training
* Behavioral: Matrix
* Behavioral: Stimulus Equivalence Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Baseline Session<br>Designated for participants #1 and #2. Participants complete 1 Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. | Behavioral: Mand Training<br>* The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.<br>Behavioral: Matrix<br>* 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.<br>Behavioral: Stimulus Equivalence Training<br>* The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.<br>|
| Experimental: Two Baseline Sessions<br>Designated for participants #3 and #4. Participants complete a Baseline Session followed by a 12 week wait period before repeating a Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. | Behavioral: Mand Training<br>* The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.<br>Behavioral: Matrix<br>* 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.<br>Behavioral: Stimulus Equivalence Training<br>* The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.<br>|
| Experimental: Three Baseline Sessions<br>Designated for participants #5 and #6. Participants complete a Baseline Session followed by two repetitions of the Baseline Session (each 12 weeks apart) and 12 weeks of standard treatment immediately following the third session. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training. | Behavioral: Mand Training<br>* The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.<br>Behavioral: Matrix<br>* 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.<br>Behavioral: Stimulus Equivalence Training<br>* The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASD, Children