Autism Spectrum Disorder With Impaired Functional LanguagePRIMeRNCT05511220
Pivotal Response Intervention Minimal Responders Study
A study testing PRIMeR and PRT in people with Autism Spectrum Disorder With Impaired Functional Language, run by IWK Health Centre at 1 site in Canada.
Trial summary
Early intervention (EI) using naturalistic behavioural methods have shown benefits for the development of communication and other skills for young children with autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder With Impaired Functional Language
- What is being tested?
- PRIMeR and PRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2022to 30 Mar 2025
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- upcoming enrollment in NS EI program for preschoolers with autism spectrum disorder (ASD), based on confirmed or provisional ASD diagnosis by a qualified clinician
- significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis)
- current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using MacArthur-Bates Communicative Development Inventory - Words \& Gestures (CDI-WG)
- limited use of toys / objects (clinician's impression or parent's report with no contrary observation by clinician)
- low levels of expressed positive affect (smiles, laughter) or limited positive and high negative affect (clinician's impression or parent's report with no contrary observation by clinician)
Who cannot join
- Severe sensory or motor impairment in child
- Parent unable to complete consent process (and receive coaching) in English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Isabel M Smith, PhD, 902-470-7275, isabel.smith@iwk.nshealth.ca
Kathryne MacLeod, BSc, 902-470-7275, kathryne.macleod@iwk.nshealth.ca
About this study
Official title: Amplifying Treatment Response in Early Intervention 'Minimal Responders' With Autism Spectrum Disorder: A Virtual Parent-Coaching Intervention
Early intervention (EI) using naturalistic behavioural methods have shown benefits for the development of communication and other skills for young children with autism spectrum disorder. The publicly funded autism EI program in Nova Scotia (NS) is based on such a method, Pivotal Response Treatment (PRT), and pre-post studies indicate benefits for children and families. However, not all children benefit equally. In this study, the investigators test the efficacy of a brief parent-mediated intervention designed to prime responsivity to PRT in children with a minimal responder profile derived from previous studies of the PRT-based EI program.
Read the detailed description
Investigators will enroll preschoolers with the minimal responder profile who are scheduled to begin the PRT-based public EI program. Consenting parents will be offered a virtual intervention in which they will be randomized to 1 of 2 arms to receive coaching in either (a) PRIMeR intervention, designed to target areas of weakness in the minimal responder profile, or (b) PRT, the treatment model used in the EI program. Coaching will take place on a virtual (video-conferencing) platform. Each child's progress on treatment targets will be assessed in a single case experimental design (SCED) using data from blind-coded video-recordings of parent-child play episodes using a standard set of toys. Overall study effects will be based on aggregated data for an anticipated n of 20 participants assigned to each arm (4 SCED series with 5 participants each contributing to each arm). The primary outcome is gains in children's social initiations (video-coded); the secondary outcome is gains in children's communication levels (multi-method assessment). Mixed methods will be used to evaluate aspects of parents' experiences,
- Being tested
- PRIMeR, PRT
- Keywords
- autism spectrum disorder, limited verbal ability, early intervention, parent-mediated intervention
- 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.
PRIMeRBehavioural
Also called Social Routines, Reciprocal Imitation Training
Virtual PRIMeR intervention consists of coaching parents to use strategies derived from Social Routines (to boost positive affect) and Reciprocal Imitation Training (to boost toy play)
PRTBehavioural
Also called Pivotal Response Treatment
Virtual PRT intervention consists of coaching parents to use key PRT strategies to enhance children's communication skills
| Study group | Role | What they receive |
|---|---|---|
| PRIMeR | Experimental | Virtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies Receives: Behavioral: PRIMeR |
| PRT | Active comparator | Virtual parent coaching in use of Pivotal Response Treatment strategies Receives: Behavioral: PRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social initiations
Change in frequency of child's social initiations toward parent, blind-coded from video sample
Measured: Assessed at baseline, entry to EI program, and after 6 months of EI program
Secondary outcomes (1)
Communication
Change in level of communication derived from Assessment of Phase of Preschool Language (APPL)
Measured: Assessed at baseline, entry to EI program, and after 6 months of EI program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start12 Jul 2022
- Primary completionOct 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder With Impaired Functional LanguageStudies 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
- Hierarchical modelling will be used to examine aggregated data from multiple single case experimental design (SCED) series (n = 5 per series), with participants randomized to 1 of 2 treatment conditions. Target is 4 SCED series per treatment condition, therefore N of 20 per condition. See Jaksic et al. (2018) for information on this method.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Isabel Smith, IWK Health Centre
- Investigators
- Isabel M Smith, PhD, Principal investigator, IWK Health Centre and Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511220
- Sponsor's protocol ID
- 1027196
- Acronym
- PRIMeR
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplifying Treatment Response in Early Intervention 'Minimal Responders' With Autism Spectrum Disorder: A Virtual Parent-Coaching Intervention
- ClinicalTrials.gov ID
- NCT05511220
- Acronym / sponsor ID
- PRIMeR / 1027196
- Keywords
- autism spectrum disorder, limited verbal ability, early intervention, parent-mediated intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 22 Aug 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.
Early intervention (EI) using naturalistic behavioural methods have shown benefits for the development of communication and other skills for young children with autism spectrum disorder. The publicly funded autism EI program in Nova Scotia (NS) is based on such a method, Pivotal Response Treatment (PRT), and pre-post studies indicate benefits for children and families. However, not all children benefit equally. In this study, the investigators test the efficacy of a brief parent-mediated intervention designed to prime responsivity to PRT in children with a minimal responder profile derived from previous studies of the PRT-based EI program.
Detailed description
Investigators will enroll preschoolers with the minimal responder profile who are scheduled to begin the PRT-based public EI program. Consenting parents will be offered a virtual intervention in which they will be randomized to 1 of 2 arms to receive coaching in either (a) PRIMeR intervention, designed to target areas of weakness in the minimal responder profile, or (b) PRT, the treatment model used in the EI program. Coaching will take place on a virtual (video-conferencing) platform. Each child's progress on treatment targets will be assessed in a single case experimental design (SCED) using data from blind-coded video-recordings of parent-child play episodes using a standard set of toys. Overall study effects will be based on aggregated data for an anticipated n of 20 participants assigned to each arm (4 SCED series with 5 participants each contributing to each arm). The primary outcome is gains in children's social initiations (video-coded); the secondary outcome is gains in children's communication levels (multi-method assessment). Mixed methods will be used to evaluate aspects of parents' experiences,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Hierarchical modelling will be used to examine aggregated data from multiple single case experimental design (SCED) series (n = 5 per series), with participants randomized to 1 of 2 treatment conditions. Target is 4 SCED series per treatment condition, therefore N of 20 per condition. See Jaksic et al. (2018) for information on this method.
| Arm | Type | Receives |
|---|---|---|
| PRIMeR | Experimental | Behavioral: PRIMeRVirtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies |
| PRT | Active comparator | Behavioral: PRTVirtual parent coaching in use of Pivotal Response Treatment strategies |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- upcoming enrollment in NS EI program for preschoolers with autism spectrum disorder (ASD), based on confirmed or provisional ASD diagnosis by a qualified clinician
- significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis)
- current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using MacArthur-Bates Communicative Development Inventory - Words \& Gestures (CDI-WG)
- limited use of toys / objects (clinician's impression or parent's report with no contrary observation by clinician)
- low levels of expressed positive affect (smiles, laughter) or limited positive and high negative affect (clinician's impression or parent's report with no contrary observation by clinician)
Key exclusion criteria (2 listed)
- Severe sensory or motor impairment in child
- Parent unable to complete consent process (and receive coaching) in English
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 |
|---|---|---|
| PRIMeRAlso: Social Routines, Reciprocal Imitation TrainingVirtual PRIMeR intervention consists of coaching parents to use strategies derived from Social Routines (to boost positive affect) and Reciprocal Imitation Training (to boost toy play) | Behavioural | PRIMeR |
| PRTAlso: Pivotal Response TreatmentVirtual PRT intervention consists of coaching parents to use key PRT strategies to enhance children's communication skills | Behavioural | PRT |
Primary outcome
Social initiations
Time frame: Assessed at baseline, entry to EI program, and after 6 months of EI program
Change in frequency of child's social initiations toward parent, blind-coded from video sample
1 secondary outcome
Communication
Time frame: Assessed at baseline, entry to EI program, and after 6 months of EI program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- 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.
Isabel M Smith, PhD principal investigator
IWK Health Centre and Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMeR and PRT in people with Autism Spectrum Disorder With Impaired Functional Language, run by IWK Health Centre at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Aug 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel M Smith, PhD (902-470-7275, isabel.smith@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social initiations (time frame: Assessed at baseline, entry to EI program, and after 6 months of EI program). 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 22 Aug 2022.