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Completed

NCT Number: NCT04675580

Telehealth Language Intervention for Children With Autism Ages 2-4 Years

The main goal of this intervention is to increase caregivers' use of interactive play and communication strategies to improve the child's early sentence development using telemedicine and video-based feedback.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Autism and the Developing Brain/New York-Presbyterian Hospital

White Plains, New York, 10605, United States

About this study

Record was updated 11/2/2021 to include more detailed information about outcome measure time points. Specifically, secondary outcome measures will be collected more frequently over the course of the study (i.e., at baseline [before starting intervention], immediate follow-up [week 12], and long-term follow-up [3 months after intervention] assessments). No changes were made to outcome measures or how they are operationalized.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of autism spectrum disorder (ASD) and/or communication disorder
  • Child speaks at least 50 single words or uses emerging word combinations
  • Caregivers have Internet availability from their home

Exclusion criteria

  • Child speaks using complex sentences
  • Child is not within 2 to 4 years of age at time of enrollment

Treatment and study plan

Toy Talk

Behavioral

Language modeling strategy encouraging caregivers to (1) talk about the toys the child is playing with, including the states, actions, and properties of the toys and (2) give the object its name using a lexical noun phrase.

Primary outcomes

  1. Change in number of unique combinations of subjects and verbs - caregiver

    Time frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12

    Number of unique combinations of subjects and verbs used by the caregiver at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

  2. Change in number of unique combinations of subjects and verbs - child

    Time frame: Baseline (Before starting intervention); Week 4; Week 8; Week 12

    Number of unique combinations of subjects and verbs used by the child at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

  3. Change in caregiver mean length of utterance

    Time frame: Baseline (before starting intervention); Week 4; Week 8; Week 12

    Mean length of utterance used by caregiver at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

  4. Change in child mean length of utterance

    Time frame: Baseline (before starting intervention); Week 4; Week 8; Week 12

    Mean length of utterance used by child at baseline, intervention midpoint, and post-evaluation. This will be calculated by transcribing 12-minute language samples from the BOSCC using Systematic Analysis of Language Transcripts (SALT) software.

  5. Change in Brief Observation of Social Communication Change (BOSCC) scores

    Time frame: Baseline (before starting intervention); Week 4; Week 8; Week 12

    Child's scores on the Brief Observation of Social Communication Change (BOSCC) at baseline, intervention midpoint, and post-evaluation. BOSCC scores are not linear. Each item is rated on a 6-point scale from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning).

Secondary outcomes

  1. Change in scores on the Observation of Spontaneous Expressive Language (OSEL) - baseline

    Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)

    Child's scores on the Observation of Spontaneous Expressive Language at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). Scores on the OSEL are not linear. Scores range from 0 to 3, with higher scores indicating more impairment.

  2. Change in scores on the Vineland-3

    Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention)

    Scores on the Vineland-3 at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The Vineland-3 provides norm-referenced scaled scores for 11 skill areas (M = 10; SD = 3) as well as standard scores (M =100, SD = 15) for three adaptive domains.

Other outcomes

  1. Change in scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II)

    Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).

    Caregiver scores on the Acceptance and Action Questionnaire, Second Version (AAQ-II) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after end of intervention). Items are rated on a Likert-type scale of 1 through 7, and scores range from 7 to 49.

  2. Change in scores on the Emotion Regulation Questionnaire (ERQ)

    Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).

    Caregiver scores on the Emotion Regulation Questionnaire (ERQ) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The ERQ is a 10-item scale with each item consisting of a 7-point Likert-type scale ranging from 1 to 7.

  3. Change in scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7)

    Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).

    Scores on the Caregiver Strain Questionnaire - Short Form 7 (CSQ-SF 7) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The CSQ-SF7 contains seven items, with response options on a five-point Likert-type scale.

  4. Change in scores on the Parent Stress Index-4th Edition (PSI-4)

    Time frame: Baseline (before starting intervention); Week 12; Follow-up assessment (3 months after end of intervention).

    Scores on the Parent Stress Index (PSI-4) at baseline, post-evaluation, and long-term follow-up evaluation (3 months after ending intervention). The PSI-4 is a 120-item inventory that provides two domain scores that are quantified using T scores (mean of 50; standard deviation of 10).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Tele Toy Talk: Telehealth Language Intervention

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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