Autism Spectrum DisorderNCT05176808
Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
A study testing Early Achievements- Parent Coaching Intervention in people with Autism Spectrum Disorder and Autistic Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. Read more about this study
- Who is it for?
- Ages 18 to 42 months
- Conditions the study is for
- Autism Spectrum Disorder, Autistic Disorder, Active Autistic Disorder
- What is being tested?
- Early Achievements- Parent Coaching Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meeting study criteria for ASD based on:
- Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months),
- Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)
- ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts
- Meeting study criteria for social communication delay based on:
- Scoring a T score of <35 on Expressive Language and/or Receptive Language subscales, Nonverbal developmental quotient of > 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception > 12 months
Show all 12Show fewer
- Nonverbal developmental quotient (DQ) of > 63 based on the Visual Reception and Fine Motor subscales
- Gestational age of 36-42 weeks;
- Birth weight of > 2,500 grams;
- Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions.
- Able to walk independently.
- Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview.
Who cannot join
- Having a primary language other than English
- Family lives >40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.
- Child lives in foster care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.
Read the detailed description
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD. The secondary hypothesis is that feasibility (defined as parent fidelity) of TC is non-inferior to IPC. An exploratory objective is to guide clinical decision-making for telehealth implementation by examining the heterogeneity of treatment response across the two treatment arms. The investigators will test the hypothesis that baseline child behavioral dysregulation, active engagement, developmental quotient, and parent stress moderate child social-communication outcomes.
After completing eligibility testing, eligible children will be randomized into the TC or IPC condition. Each condition will involve twice weekly coaching sessions over 8-12 weeks. At the end of the intervention period, participants will be reassessed.
- Conditions
- Autism Spectrum Disorder, Autistic Disorder, Active Autistic Disorder, Autism, Asperger Syndrome, PDD-NOS
- Being tested
- Early Achievements- Parent Coaching Intervention
- Keywords
- Social Communication, Language, Engagement
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Communication, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Achievements- Parent Coaching InterventionBehavioural
Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Parent Coaching (TC) | Active comparator | A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting the child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with 2 sessions per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD or social communication delays following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Trained study coaches will join families in their homes remotely via Kennedy Krieger Institute's secure Zoom password-protected account to provide coaching. Receives: Behavioral: Early Achievements- Parent Coaching Intervention |
| In-person Coaching(IPC) | Active comparator | A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with sessions 2 times per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Coaching will be delivered in families' homes by trained study coaches to support parent implementation of NDBI strategies during daily life activities with their toddler with ASD or social communication delays. Receives: Behavioral: Early Achievements- Parent Coaching Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Duration of Joint Attention
10 minute caregiver/child play samples will be coded using an engagement coding schema. The schema differentiates different levels of engagement. This data will be used to compare duration of engagement states at pre- and post-testing.
Measured: 8-12 weeks
Parent Fidelity of Implementation
Parent fidelity of implementation will be coded from the parent-child interaction sample obtained within the home at baseline and post-intervention by trained (to reliability) research assistants blind to group membership and timing of sample. This form consists of 26-items, where each item is rated using a 3-point Likert-type scale. Items reflect the key elements of Natural Developmental Behavioral Interventions (NDBI) which have been assessed in parent-implemented NDBI studies found to improve child social-communication outcomes. Ratings are based on effectiveness (well-timed, variety, developmental appropriateness) and frequency/consistency.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start7 Feb 2022
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon confirmation of eligibility and completion of the baseline assessments, participants will be randomly assigned to the TC or IPC study condition. Randomization will be done in randomly permuted groups of different sizes to reduce predictability of treatment assignment, with one half of the parent-child dyads in each block assigned to the IPC arm and one half assigned to the TC condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Rebecca Landa, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Rachel Reetzke, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176808
- Sponsor's protocol ID
- IRB00279093
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ingersoll B, Wainer AL, Berger NI, Pickard KE, Bonter N. Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. J Autism Dev Disord. 2016 Jul;46(7):2275-84. doi: 10.1007/s10803-016-2755-z.
PubMed 26922192
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD
- ClinicalTrials.gov ID
- NCT05176808
- Acronym / sponsor ID
- IRB00279093
- Conditions
- Autism Spectrum Disorder, Autistic Disorder, Active Autistic Disorder, Autism, Asperger Syndrome, PDD-NOS
- Keywords
- Social Communication, Language, Engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- United States Department of Defense, Johns Hopkins Bloomberg School of Public Health
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.
Detailed description
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD. The secondary hypothesis is that feasibility (defined as parent fidelity) of TC is non-inferior to IPC. An exploratory objective is to guide clinical decision-making for telehealth implementation by examining the heterogeneity of treatment response across the two treatment arms. The investigators will test the hypothesis that baseline child behavioral dysregulation, active engagement, developmental quotient, and parent stress moderate child social-communication outcomes.
After completing eligibility testing, eligible children will be randomized into the TC or IPC condition. Each condition will involve twice weekly coaching sessions over 8-12 weeks. At the end of the intervention period, participants will be reassessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Upon confirmation of eligibility and completion of the baseline assessments, participants will be randomly assigned to the TC or IPC study condition. Randomization will be done in randomly permuted groups of different sizes to reduce predictability of treatment assignment, with one half of the parent-child dyads in each block assigned to the IPC arm and one half assigned to the TC condition.
| Arm | Type | Receives |
|---|---|---|
| Telehealth Parent Coaching (TC) | Active comparator | Behavioral: Early Achievements- Parent Coaching InterventionA family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting the child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with 2 sessions per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD or social communication delays following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Trained study coaches will join families in their homes remotely via Kennedy Krieger Institute's secure Zoom password-protected account to provide coaching. |
| In-person Coaching(IPC) | Active comparator | Behavioral: Early Achievements- Parent Coaching InterventionA family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with sessions 2 times per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Coaching will be delivered in families' homes by trained study coaches to support parent implementation of NDBI strategies during daily life activities with their toddler with ASD or social communication delays. |
Who may qualify
- Ages
- 18 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Meeting study criteria for ASD based on:
- Meeting study criteria for social communication delay based on:
- Nonverbal developmental quotient (DQ) of > 63 based on the Visual Reception and Fine Motor subscales
- Gestational age of 36-42 weeks;
- Birth weight of > 2,500 grams;
Key exclusion criteria (3 listed)
- Having a primary language other than English
- Family lives >40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.
- Child lives in foster care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Achievements- Parent Coaching InterventionChildren, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles. | Behavioural | In-person Coaching(IPC), Telehealth Parent Coaching (TC) |
Primary outcome
Child Duration of Joint Attention
Time frame: 8-12 weeks
10 minute caregiver/child play samples will be coded using an engagement coding schema. The schema differentiates different levels of engagement. This data will be used to compare duration of engagement states at pre- and post-testing.
Parent Fidelity of Implementation
Time frame: 8-12 weeks
Parent fidelity of implementation will be coded from the parent-child interaction sample obtained within the home at baseline and post-intervention by trained (to reliability) research assistants blind to group membership and timing of sample. This form consists of 26-items, where each item is rated using a 3-point Likert-type scale. Items reflect the key elements of Natural Developmental Behavioral Interventions (NDBI) which have been assessed in parent-implemented NDBI studies found to improve child social-communication outcomes. Ratings are based on effectiveness (well-timed, variety, developmental appropriateness) and frequency/consistency.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 26922192Ingersoll B, Wainer AL, Berger NI, Pickard KE, Bonter N. Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. J Autism Dev Disord. 2016 Jul;46(7):2275-84. doi: 10.1007/s10803-016-2755-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Landa, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Rachel Reetzke, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Achievements- Parent Coaching Intervention in people with Autism Spectrum Disorder and Autistic Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Duration of Joint Attention (time frame: 8-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05176808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.