Autism Spectrum DisorderPhase 2NCT04501588
Parent Telehealth Intervention for Children With Autism
A Phase 2 study testing Responsive training with no video feedback and Responsive training with video feedback in people with Autism Spectrum Disorder and Autism, run by Northwestern University at 1 site in United States.
Trial summary
As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. Read more about this study
- Who is it for?
- Ages 18 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Responsive training with no video feedback and Responsive training with video feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 24 Nov 2021
- Phase
- Phase 2
- 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 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child inclusion criteria include:
- diagnosis of ASD or showing signs of ASD based on autism screening
- chronological age of less than 48 months
- a parent who is willing to learn intervention strategies
- English as the primary language spoken in the home
- Parent inclusion criteria include:
- Biological Mother
Who cannot join
- Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study.
- Fathers or caregivers other than the child's Mother will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent Language Intervention for Autism
As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Responsive training with no video feedback, Responsive training with video feedback
- Keywords
- autism, parent intervention, parent coaching, early intervention, parent-mediated intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsive training with no video feedbackBehavioural
Also called No Video Feedback
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Responsive training with video feedbackBehavioural
Also called Video Feedback
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
| Study group | Role | What they receive |
|---|---|---|
| Parent Learning Style 1 | Experimental | Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. Receives: Behavioral: Responsive training with no video feedback |
| Parent Learning Style 2 | Experimental | Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. Receives: Behavioral: Responsive training with video feedback |
| Learning Style 1 (Parent) | Active comparator | Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. Receives: Behavioral: Responsive training with video feedback |
| Learning Style 2 (Parent) | Active comparator | Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. Receives: Behavioral: Responsive training with no video feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Use of Language Support Strategies (Mother-child interaction)
Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys. The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct. This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds).
Measured: Two months after the start of the study
Secondary outcomes (1)
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Parent report of child's expressive vocabulary and prelinguistic communication skills
Measured: Two months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start6 Mar 2020
- Primary completion2 Sep 2021
- Study completion24 Nov 2021
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.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501588
- Sponsor's protocol ID
- STU00201708
- Status last verified
- Jan 2022
- First submitted
- 3 Aug 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A at this time
Publications
Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.
PubMed 25733749
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Language Intervention for Autism
- ClinicalTrials.gov ID
- NCT04501588
- Acronym / sponsor ID
- STU00201708
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- autism, parent intervention, parent coaching, early intervention, parent-mediated intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 6 Aug 2020 (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.
As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance. Given this, parents in the study will receive parent coaching through weekly video calls. To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback. This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity. Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.
| Arm | Type | Receives |
|---|---|---|
| Parent Learning Style 1 | Experimental | Behavioral: Responsive training with no video feedbackMothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. |
| Parent Learning Style 2 | Experimental | Behavioral: Responsive training with video feedbackMothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. |
| Learning Style 1 (Parent) | Active comparator | Behavioral: Responsive training with video feedbackMothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. |
| Learning Style 2 (Parent) | Active comparator | Behavioral: Responsive training with no video feedbackMothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback. |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- diagnosis of ASD or showing signs of ASD based on autism screening
- chronological age of less than 48 months
- a parent who is willing to learn intervention strategies
- English as the primary language spoken in the home
- Biological Mother
Key exclusion criteria (2 listed)
- Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study.
- Fathers or caregivers other than the child's Mother will be excluded from the study.
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 |
|---|---|---|
| Responsive training with no video feedbackAlso: No Video FeedbackParents will receive responsive training, but will not watch themselves on video to reflect on their strategy use. | Behavioural | Learning Style 2 (Parent), Parent Learning Style 1 |
| Responsive training with video feedbackAlso: Video FeedbackParents will receive responsive training and watch themselves on video to reflect on their strategy use. | Behavioural | Learning Style 1 (Parent), Parent Learning Style 2 |
Primary outcome
Parent Use of Language Support Strategies (Mother-child interaction)
Time frame: Two months after the start of the study
Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys. The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct. This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds).
1 secondary outcome
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Time frame: Two months after the start of the study
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 10 Jan 2022.
- Background: PubMed 25733749Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.
- Individual participant dataSharing planned: No. N/A at this time
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Responsive training with no video feedback and Responsive training with video feedback in people with Autism Spectrum Disorder and Autism, run by Northwestern University 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 7 inclusion and 2 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 10 Jan 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parent Use of Language Support Strategies (Mother-child interaction) (time frame: Two months after the start of the study). 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 NCT04501588, 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 10 Jan 2022.