NCT05277103

Brief Summary

This study will examine what child variables (i.e., social attention and peer interest) predict communication gains in response to a peer-mediated intervention for 40 minimally-verbal preschool children with ASD and 80 peers. The Stay-Play-Talk with iPad intervention will be implemented for 8 weeks. Gains in communication and reciprocity with peers will be measured at post-treatment and in non-treatment settings. Another goal is to determine if variance in communication gains accounted for by the two social variables differs based on the pre-treatment measurement context.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

August 9, 2024

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

February 2, 2022

Last Update Submit

August 7, 2024

Conditions

Keywords

Augmentative and Alternative Communication Systems

Outcome Measures

Primary Outcomes (4)

  • Social Attention

    For the semi-structured (12 min total) and naturalistic assessments (30 min total), social attention will be: (a) total % time child visually attends to peer's face, and (b) total % time child visually attends to the adult's face. For eye tracking assessments, social attention will be total % time child visually attends to adult and peer faces in the Static and Dynamic Visual Exploration Tasks.

    Pre-Test

  • Peer interest

    For semi-structured and naturalistic assessments, peer interest will be total rates of (a) child joint attention to peer actions/activities, by looking at the object being acted on then to peer's face within 5 sec, and (b) child imitation of peer actions/activities within 5 sec. For eye tracking assessments, peer interest will be total % time child visually attends to peer faces and activities during the Interactive Visual Exploration Task.

    Pre-Test

  • Rates of focal child communication

    Total frequency of child communication acts will be coded during three 10-min sessions prior to the start of treatment in (1) activities that will be the same as in treatment (30 min total), and (2) activities in two generalization settings (snack and free play) (30 min total). Intentional, spontaneous child communication acts that are clearly directed to the peer using eye contact or body orientation including gestures, speech, SGD use, or speech+SGD (e.g., to request objects/actions, comment, or to protest) will be coded. Communication to adults will not be coded. Data will be averaged across the three observations (or 30 min) and converted to a rate per minute to be used in the analyses.

    Baseline, 16 weeks Post-Treatment, and generalization probes (two 10-min sns) collected at baseline and 16 weeks post-treatment

  • Rates of reciprocal child-peer exchanges

    Total rates of reciprocal communication exchanges between the focal child and peer will be coded during three 10-min sessions in baseline, three 10-min sessions at 8 week post-treatment, and two 10-min non-treatment/generalization sessions. Data will be averaged across each set of observations (or 30 min per baseline and treatment phase; 20 min in generalization phase) and converted to a rate per minute to be used in the analyses. Each intentional communication act will be coded as an initiation or a response, with responses coded if observed within 5 seconds of another child's communication act. A reciprocal exchange requires a minimum of one initiation and one response sequence between the focal child and peer (either partner can begin the exchange).

    Baseline, at 16 weeks Post-Treatment, and generalization probes collected at baseline and 16 weeks post-treatment

Study Arms (1)

Stay-Play-Talk with iPad Intervention

EXPERIMENTAL

Peers without disabilities will be taught to be active communication partners using an iPad with voice output app as a speech-generating device, then paired up to play with one child with ASD for 16 sessions over 8 weeks. Focal child behaviors are assessed in different pre-treatment contexts (i.e., eye tracking, structured play, and naturalistic classroom settings), and rate of communication will be collected to predict gains children make in social communication with peers after treatment.

Behavioral: Exploring predictors of response to a peer-mediated communication intervention for minimally verbal preschoolers with ASD

Interventions

The intervention, Stay-Play-Talk with iPad, incorporates SGD instruction and peer training, both demonstrated to be effective in increasing communication and social interactions of preschool-age children with ASD. Children with ASD will be provided with an iPad with Touch Chat voice output app (the SGD) to use throughout the project. Two peers are recruited for each child with ASD. Research staff will implement peer training for three 30-min sessions, with peers taught to: STAY - sit close; PLAY- share and take turns; and TALK with iPad - look and listen/push and talk. After peers are trained, they will take turns engaging in common preschool games and preferred play activities with one assigned child with ASD (1 child:1 peer). Treatment will be provided for 15-20 min, twice per week for 8 weeks in the classroom.

Also known as: Stay-Play-Talk with iPad
Stay-Play-Talk with iPad Intervention

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with ASD (N=40) between 3 to 6 years of age; diagnosis confirmed based on DSM-V criteria (APA, 2013) and administration of the Autism Diagnostic Observational Schedule-2 (ADOS-2; Lord et al., 2012).
  • minimally verbal defined as less than 20 functional, spontaneous words, signs, or symbols
  • currently using or a candidate for a SGD to augment communication
  • symbol discrimination skills based on pre-treatment assessment with an adult partner using a matching-to-sample procedure and a minimum choice of one preferred item and one foil
  • English as the primary language spoken at home.

You may not qualify if:

  • co-morbid or previously identified genetic conditions associated with ASD (e.g., Fragile X)
  • visual impairment, deafness, or other sensory disabilities
  • a lack of symbol discrimination skills
  • Peer Partners:
  • ages of 3 and 6 years (N=80 total over 2 years).
  • recommended by school staff based on meeting six of the eight following criteria: 1) follows simple 2-step directions, (2) responds positively to adult requests to modify or change undesirable behaviors, (3) appropriately approaches and invites other children to play, (4) is comfortable talking to and interacting with other children while playing, (5) takes turns and shares toys with other children, (6) offers to help other children set up play routines or complete tasks, (7) is well-liked by many children in the classroom, and (8) will stay and play with other children for an appropriate length of time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Kansas City, Kansas, 66101, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderNonverbal Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Study Officials

  • Kathy Thiemann-Bourque, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 14, 2022

Study Start

September 21, 2021

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

August 9, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

The proposed study will include information on child variables that predict response to a peer-mediated intervention, and the impact of different measurement contexts on child performance, for 40 minimally-verbal preschool-age children with autism spectrum disorder (ASD) and 80 peers without disabilities. All data collected will be stripped of identifiers prior to release of sharing data. We will make the data available under a data-sharing agreement that provides for a commitment to use the data only for research purposes and not to identify any participating students or peers. This agreement will also include a commitment to securing the data using appropriate privacy safeguards and computer technology as approved by the Institutional Research Review Board at the University of Kansas, and destroying the data after analyses are complete.

Time Frame
To disseminate the findings of this study, the study results will be reported in clinicaltrials.gov within 1 year of study completion.

Locations