NCT02555241

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

September 17, 2015

Last Update Submit

December 2, 2016

Conditions

Keywords

ASD, Children

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in Macarthur Bates-Communicative Development Inventory (CDI) Score

    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).

    Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)

Study Arms (3)

One Baseline Session

EXPERIMENTAL

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 TrainingBehavioral: MatrixBehavioral: Stimulus Equivalence Training

Two Baseline Sessions

EXPERIMENTAL

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 TrainingBehavioral: MatrixBehavioral: Stimulus Equivalence Training

Three Baseline Sessions

EXPERIMENTAL

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 TrainingBehavioral: MatrixBehavioral: Stimulus Equivalence Training

Interventions

Mand TrainingBEHAVIORAL

The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.

One Baseline SessionThree Baseline SessionsTwo Baseline Sessions
MatrixBEHAVIORAL

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.

One Baseline SessionThree Baseline SessionsTwo Baseline Sessions

The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.

One Baseline SessionThree Baseline SessionsTwo Baseline Sessions

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children with significant problem behavior that interferes with structured intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alice Shillingsburg

    Emory University Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 21, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12