Autism Spectrum DisorderNCT06011707
OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder
A study testing OPT-IN in people with Autism Spectrum Disorder, run by Elizabeth Kelley.
Trial summary
The goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- OPT-IN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline
Who cannot join
- Parent does not speak English well enough to complete questionnaires
- Parent or child has complete vision or hearing loss.
- Parent or child is medically unstable.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial
The goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. The main question[s] it aims to answer are:
- Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group?
- Does an online intervention for autistic children result in reduced autism symptoms in children, and decreased stress and increased self-efficacy in parents, compared to a psychoeducational control group?
- What are the predictors of response to intervention (i.e., child sex and age; initial autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education).
Read more
Parents will be given six compulsory and eight optional online modules that will teach them skills to use while interacting with their autistic children to improve social and communication behaviours and minimize behaviours that interfere with learning.
The comparison group will receive six compulsory and eight optional online modules that will teach them about autism more broadly including diagnostic criteria, symptom profiles across development, etc.
- Conditions
- Autism Spectrum Disorder
- Being tested
- OPT-IN, Psychoeducational control
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT-INBehavioural
Parents will be provided with online access to 6 compulsory video-based modules and 8 optional video-based modules. These modules will teach them about child development, behavioural principles, and naturalistic developmental intervention principles. These modules will promote skills that parents can use to increase their child's social and communication behaviours and minimize behaviours that interfere with learning (e.g., temper tantrums).
Psychoeducational controlOther
This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.
| Study group | Role | What they receive |
|---|---|---|
| OPT-IN intervention | Experimental | Not described Receives: Behavioral: OPT-IN |
| Psychoeducational control | Active comparator | Not described Receives: Other: Psychoeducational control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adaptive Behavior
Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview
Measured: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Secondary outcomes (4)
Change in Autism Symptoms
Change in Autism Impact Measure
Measured: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Parenting Stress
Change in Parenting Stress Index, Short Form, version 4
Measured: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Parental Self-Efficacy
Change in Early Intervention Parenting Self-Efficacy Scale
Measured: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Language
Change in MacArthur-Bates Communicative Development Inventory
Measured: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Jun 2024 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth Kelley
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Children's Hospital, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Eastern Ontario, Child and Community Resources
- Responsible party
- Sponsor-investigator, Elizabeth Kelley, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011707
- Sponsor's protocol ID
- OPTIN
- Status last verified
- May 2024
- First submitted
- 24 Apr 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers through this website. The data will be de-identified by eliminating birthdate.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06011707
- Acronym / sponsor ID
- OPTIN
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Elizabeth KelleyUniversity, hospital or other
- Collaborators
- McMaster Children's Hospital, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Eastern Ontario, Child and Community Resources
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Aug 2023 (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 goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. The main question[s] it aims to answer are:
- Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group?
- Does an online intervention for autistic children result in reduced autism symptoms in children, and decreased stress and increased self-efficacy in parents, compared to a psychoeducational control group?
- What are the predictors of response to intervention (i.e., child sex and age; initial autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education).
Parents will be given six compulsory and eight optional online modules that will teach them skills to use while interacting with their autistic children to improve social and communication behaviours and minimize behaviours that interfere with learning.
The comparison group will receive six compulsory and eight optional online modules that will teach them about autism more broadly including diagnostic criteria, symptom profiles across development, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPT-IN intervention | Experimental | Behavioral: OPT-IN |
| Psychoeducational control | Active comparator | Other: Psychoeducational control |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline
Key exclusion criteria (3 listed)
- Parent does not speak English well enough to complete questionnaires
- Parent or child has complete vision or hearing loss.
- Parent or child is medically unstable.
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 |
|---|---|---|
| OPT-INParents will be provided with online access to 6 compulsory video-based modules and 8 optional video-based modules. These modules will teach them about child development, behavioural principles, and naturalistic developmental intervention principles. These modules will promote skills that parents can use to increase their child's social and communication behaviours and minimize behaviours that interfere with learning (e.g., temper tantrums). | Behavioural | OPT-IN intervention |
| Psychoeducational controlThis control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course. | Other | Psychoeducational control |
Primary outcome
Change in Adaptive Behavior
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview
4 secondary outcomes
Change in Autism Symptoms
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Parenting Stress
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Parental Self-Efficacy
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Language
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers through this website. The data will be de-identified by eliminating birthdate.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Questions about this trial
What is this clinical trial studying?
A study testing OPT-IN in people with Autism Spectrum Disorder, run by Elizabeth Kelley.
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 1 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: opening soon, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth A Kelley, PhD (613-533-2491, kelleyb@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adaptive Behavior (time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2024.