NCT03152383

Brief Summary

The purpose of this study is to compare how children with autism, typically developing children, and children with other developmental delays value social attention and toys. The first part of the study seeks to determine whether breakpoints when responding on progressive ratio (PR) schedules can be used to determine the value of leisure items and attention. By comparing the breakpoints obtained for leisure items and attention, the researchers will determine the differential valuation of leisure items and attention. It is anticipated that the manner in which individuals with an autism spectrum disorder (ASD) diagnosis and those who do not will differ with respect to the degree to which they value these two types of stimuli. The second part of the study seeks to determine whether an intervention in which social attention is paired with primary reinforcers impacts responding during the PR assessment, in children with ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

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

June 22, 2012

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

8.5 years

First QC Date

May 11, 2017

Last Update Submit

May 10, 2023

Conditions

Keywords

Autism Spectrum DisorderBehavioral ResearchPsychologyCognitive Disorders

Outcome Measures

Primary Outcomes (2)

  • Breakpoint achieved for each stimulus

    The highest schedule requirement completed (i.e., breakpoint) is used as a measure of how much an individual is willing to respond for a given stimulus.

    Up to one week

  • Change in breakpoints

    For children receiving the intervention the change between breakpoints across the two PR assessments conducted before and after intervention will be examined.

    Assessment 1 through repeat assessment (up to 4 weeks)

Study Arms (3)

Autism Spectrum Disorder

EXPERIMENTAL

Children diagnosed as having autism spectrum disorder

Behavioral: Training trialsBehavioral: Progressive Ratio SessionBehavioral: Re-testBehavioral: Pairing Protocol

Typically developing

ACTIVE COMPARATOR

Children who are typically developing

Behavioral: Training trialsBehavioral: Progressive Ratio Session

Other Developmental Delay

ACTIVE COMPARATOR

Children diagnosed with a developmental delay other than autism spectrum disorder

Behavioral: Training trialsBehavioral: Progressive Ratio Session

Interventions

Training trialsBEHAVIORAL

A highly preferred edible item will be selected to teach the contingencies for the assessment. Materials to engage in the work response (i.e., button press) will be placed within arm's reach of the child, and the edible item will be in sight. The therapist will deliver a vocal prompt for the child to engage in the work response (e.g., "press the button and you can have some candy"). If the child engages in the response, the therapist immediately delivers the edible item. The therapist will guide the child to engage in the instrumental response, and will then gradually begin to fade the prompt level. If the child makes an error at any level of prompting, the therapist will guide the participant to emit a correct response. The edible item will be delivered to the child each time that the child responds correctly at any prompt level.

Autism Spectrum DisorderOther Developmental DelayTypically developing

The child will be guided to engage in the instrumental response then the stimulus will be immediately delivered for 30 seconds. The leisure item or the individual who will provide attention will be directly outside of the session room. If the child emits the work response, they will be allowed access to either a leisure item or to attention (depending on the condition) for 30 seconds. The child is initially required to respond one time, then they will be required to respond two times to gain access to the item or attention (then 4, then 8, and so on) such that the response requirement progressively increases according to a pre-determined schedule. A minimum of 3 sessions will be conducted for each condition. The amount of time required for participation depends on the child's responding, and caregiver availability. Participation may take as little as a couple hours, or as long as 3-4 hours per day for approximately one week.

Autism Spectrum DisorderOther Developmental DelayTypically developing
Re-testBEHAVIORAL

10 children with ASD will return to repeat the progressive ratio (PR) assessment one week after completing it the first time to examine the reliability of the measure.

Autism Spectrum Disorder

15 children with ASD will receive an intervention designed to increase social approach after completing the PR assessment. Participants will attend 2 hour appointments 3-5 days per week in which a therapist will deliver highly preferred items, play with the child, work on teaching communication skills, and teach the child to comply with demands. After completing the intervention (once the child is willingly staying near and interacting with the therapist and complying with instructions), the PR assessment will be repeated to measure change due to the intervention.

Autism Spectrum Disorder

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 3 and 6.
  • Presence of an autism diagnosis as determined by The Autism Diagnostic Observation Schedule (ADOS).
  • Adaptive functioning typical of autism as determined by the Vineland Adaptive Behavior Scales (VABS-II; survey interview form).
  • Completion of the Social Responsiveness Scale (SRS) to assess social impairment.
  • Completion of the Early Social Communication Scales to assess non-verbal communication.
  • Between the ages of 3 and 6.
  • Current developmental level determined to be not developmentally delayed per The Mullen Scales of Early Learning (MSEL) or Differential Ability Scale (DAS; depending on participant age).
  • Between the ages of 3 and 6.
  • Current developmental level determined to be developmentally delayed per The Mullen Scales of Early Learning (MSEL) or Differential Ability Scale (DAS; depending on participant age).

You may not qualify if:

  • Caregiver does not give permission for protective procedures and emergency protocols to be used if the child participant exhibits problem behaviors during a study visit.
  • Children who are not able to master the training trial within 10 sessions will not participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderCognitive Dysfunction

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Nathan A Call, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Children with autism, typically developing children, and children with developmental disabilities will participate in the same intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

June 22, 2012

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations