TerminatedNot Applicable

Training Early Social Language in Autism

Stopped: The 2020-2022 Covid-19 pandemic ended this study before completion

United States89 participantsStarted 2016-07-01

Plain-language summary

The aim of the study is to determine whether a targeted behavioral intervention can lead to both changes in early communication skills and in neural responses in toddlers and preschoolers with autism.

Who can participate

Age range

18 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children between the ages of 18 and 59 months with a confirmed or suspected DSM5 diagnosis of autism spectrum disorder * The included parents or guardians are required to be the primary caregivers of these children * Families must speak English in the home at least 75% of the time. Exclusion Criteria: * Seizure disorder (may influence EEG data) * Gestational age \<32 weeks * History of serious head trauma * Genetic syndrome (e.g., fragile X syndrome)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in EEG Frequency Data- Resting State

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in EEG Frequency Data- Grasping Objects

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in EEG Frequency Data- Observing actions

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in joint attention measured with the Early Social and Communication scales (ESCS)

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in play level measured with the Structured Play Assessment (SPA)

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Trial details

NCT IDNCT03427138

SponsorBoston University Charles River Campus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Who can participate

Age range

18 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in EEG Frequency Data- Resting State

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in EEG Frequency Data- Grasping Objects

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in EEG Frequency Data- Observing actions

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in joint attention measured with the Early Social and Communication scales (ESCS)

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in play level measured with the Structured Play Assessment (SPA)

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)

Timeframe: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11