Autism Spectrum DisorderSAPIENSNCT05208411
Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD
A study testing Project ImPACT: Improving Parents As Communication Teachers in people with Autism Spectrum Disorder, run by University Ghent at 1 site in Belgium.
Trial summary
This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of infants with elevated likelihood of Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 9 to 18 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Project ImPACT: Improving Parents As Communication Teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Mar 2022to Dec 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 9 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elevated likelihood of ASD: the child must be a preterm (less than 30 weeks of gestation) or a sibling/half-sibling of a child with diagnosed ASD.
- Parents are Dutch, English on French speakers.
Who cannot join
- The child must not have a diagnosis of other neurological or developmental disorders.
Trial locations and contacts
1 site in 1 country.
Prof. dr. Herbert Roeyers, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, Oost-Vlaanderen, 9000
Sara Van der Paelt, PhD, +32 486 93 14 48, sara.vanderpaelt@ugent.be
Arianna Zanatta, MSc
About this study
Official title: The Impact of a Parent-mediated Intervention on Social Behaviour and Social Brain Development in Infants at High Risk for Autism Spectrum Disorder
This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of infants with elevated likelihood of Autism Spectrum Disorder (ASD). The children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and 6 months after its conclusion (follow-up).
Read the detailed description
Previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (ASD).Considering that several differences in social and non-social skills start to emerge before a diagnosis can be made, this project aims to investigate the effects of an adapted prodromal version of an evidence-based parent-mediated intervention (Project ImPACT) in children with an elevated likelihood to develop ASD (namely siblings and children who were born preterm). The effect of the intervention will be evaluated at both behavioural and neural levels. The intervention is suitable for infants and consists of 12 session with the child and his/her parents, of maximum 2 hours each, one session per week, delivered by therapists of the home guidance and home guidance centers in Flanders. Children between 9 and 18 months old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention group or a no-intervention group (monitoring only). The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 12 weeks) and 24 weeks after the end of the intervention.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Project ImPACT: Improving Parents As Communication Teachers
- Keywords
- Autism, Autism Spectrum Disorder, Siblings, Preterm, Elevated likelihood of ASD
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ImPACT: Improving Parents As Communication TeachersBehavioural
Project ImPACT ("Improving Parents As Communication Teachers", Ingersoll \& Dvortcsak, 2019) is a promising evidence-based parent-mediated intervention that is part of a class of naturalistic, developmental, behavioral interventions (NBDIs). NBDIs involve the use of behavioral principles of learning to teach skills chosen from a developmental sequence in naturalistic play-setting and using natural rewards. Skills selected as relevant for intervention are those that allow the child to participate more fully within reciprocal interactions with the adult. In recent years the program has been adapted for use with infants and toddlers at elevated likelihood of ASD. These adaptations have made this program appropriate for younger children and children who are experiencing social communication delays but do not have an ASD diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| ImPACT group | Experimental | Group of children at elevated likelihood of ASD who will receive the ImPACT intervention Receives: Behavioral: Project ImPACT: Improving Parents As Communication Teachers |
| No intervention group | No intervention | Group of children at elevated likelihood of ASD who won't receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bigger change from baseline in the parent-child interaction in the intervention group compared to the no-intervention group.
Change in quality and frequency of behaviours (with the same unit of measure) within the Parent-Child Interaction coded through the Parent-Infant/Toddler Coding of Interaction (PInTCI). An increase is considered as a positive outcome.
Measured: Outcome at 3 months after entry(post-test)
Bigger change from post-test in the intervention group in the parent-child interaction compared to the no-intervention group.
Change in quality and frequency of behaviours (with the same unit of measure) within the Parent-Child Interaction coded through the Parent-Infant/Toddler Coding of Interaction (PInTCI). An increase is considered as a positive outcome.
Measured: Follow-up at 6 months after post-test
Secondary outcomes (15)
Bigger change from baseline in Social Engagement in the intervention group compared to the no-intervention group.
Duration of the engagement in interactive play with the adult. Consider whether the child 1) engages in interactive play, 2) follows the adult's lead in play activities; 3) sustains interactive play (e.g. by requesting for the activity to continue) and 4) initiates the adults engagement in interactive play. The total Social Engagement score will consist of a composite score of the abovementioned aspects coded during the administration of both the Communication and Symbolic Behavior Scale (CSBS) and the Early Social Communication Scales (ESCS).
Higher frequency and longer social engagement time is considered positive outcome.
Measured: outcome at 3 months after entry (post-test)
Bigger change from baseline in the score of imitation in the intervention group compared to the no-intervention group.
Semi-structured social imitation task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is used. The score ranges from 0 to 20, with higher scores corresponding to higher social imitation rates.
Score increase is a positive outcome.
Measured: outcome at 3 months after entry (post-test)
Bigger change from baseline in the score of intentional communication in the intervention group compared to the no-intervention group
Composite weighted frequency of unprompted intentional triadic communication (initiations), obtained by multiplying each unprompted triadic communication act by the weight assigned to the behaviour used to communicate. The total Intentional Communication score will consist of a composite score of the abovementioned aspects coded during the administration of both the Communication and Symbolic Behavior Scale (CSBS) and the Early Social Communication Scales (ESCS).
Score increase is a positive outcome.
Measured: outcome at 3 months after entry (post-test)
Bigger change from baseline in attention disengagement in the intervention group compared to the no-intervention group
Attention disengagement is defined as the time needed to shift the gaze to a peripheral target. It's measured with an Eye-tracker while presenting a well-known paradigm called Gap-Overlap task.
Decrease in Attention disengagement time is considered as a positive outcome.
Measured: outcome at 3 months after entry (post-test)
Bigger change from baseline in the intervention group compared to the no-intervention group in electrophysiological spectral power and connectivity (theta and alpha band) in response to social versus non-social videos, measured with EEG.
EEG activity recorded while children watch videos of abstract figures moving (resting-state), social scenes (nursery rhymes) and non-social scenes (toys moving).
Measured: outcome at 3 months after entry (post-test)
Bigger change from post-test in the intervention group in the score of Social Engagement compared to the no-intervention group.
Duration of the engagement in interactive play with the adult. Consider whether the child 1) engages in interactive play, 2) follows the adult's lead in play activities; 3) sustains interactive play (e.g. by requesting for the activity to continue) and 4) initiates the adults engagement in interactive play. The total Social Engagement score will consist of a composite score of the abovementioned aspects coded during the administration of both the Communication and Symbolic Behavior Scale (CSBS) and the Early Social Communication Scales (ESCS). Score stability (after increase at outcome) or increase is a positive outcome.
Measured: follow-up at 6 months after post-test
Bigger change from post-test in the score of a semi-structured social imitation task compared to the no-intervention group.
Semi-structured social imitation task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is used. The score ranges from 0 to 20, with higher scores corresponding to higher social imitation rates.
Score stability (after increase at outcome) or increase is a positive outcome.
Measured: follow-up at 6 months after post-test
Bigger change from post-test in the score of intentional communication in the intervention group compared to the no-intervention group
Composite weighted frequency of unprompted intentional triadic communication (initiations), obtained by multiplying each unprompted triadic communication act by the weight assigned to the behaviour used to communicate. The total Intentional Communication score will consist of a composite score of the abovementioned aspects coded during the administration of both the Communication and Symbolic Behavior Scale (CSBS) and the Early Social Communication Scales (ESCS). Score stability (after increase at outcome) or increase is a positive outcome.
Measured: follow-up at 6 months after post-test
Bigger change from post-test in the intervention group in electrophysiological spectral power and connectivity (theta and alpha band) in response to social versus non-social videos, measured with EEG.
EEG activity recorded while children watch videos of abstract figures moving (resting-state), social scenes (nursery rhymes) and non-social scenes (toys moving).
Measured: follow-up at 6 months after post-test
Bigger change from post-test in attention disengagement in the intervention group compared to the no-intervention group, measured with Eye-tracking
Attention disengagement is the time needed to shift the gaze to a peripheral target. It's measured with an Eye-tracker while presenting a well-known paradigm called Gap-Overlap task.
Attention disengagement time stability (after decrease at outcome) or decrease is a positive outcome.
Measured: follow-up at 6 months after post-test
Difference between intervention and no-intervention group in the severity score of the Autism Diagnostic Observational Scale - 2 (ADOS-2).
A standard measure internationally used to identify symptoms of autism. The total score ranges from 0 to 30, with a higher score corresponding to higher symptom severity. The total score results from the sum of two subscales: the Social Affect subscale (SA), with scores ranging from 0 to 22, and the Restricted and Repetitive Behavior one (RRB), with scores ranging from 0 to 8. The ADOS-2 total score is converted through an age-dependent algorithm to a diagnostic ordinal scale ranging from 0 to 10 (with higher scores indicating higher symptom severity), based on which a diagnostic classification can be formulated (no ASD, ASD, autism).
A lower total score in the intervention group, as well as in a subscale score, compared to the no-intervention group is considered a positive outcome.
Measured: outcome at 9 months after entry
Bigger change from baseline in the in the intervention group in the score of the Bayley Scales of Infant and Toddler Development - Third Edition - NL compared to the no-intervention group.
An age-appropriate measure of cognitive, language, motor and social-emotional development for children from 0 to 42 months. A high growth rate (= the change in months is higher than the number of months actually passed between baseline and follow-up) in a domain where a child initially showed a delay is considered a positive outcome.
Measured: outcome at 9 months after entry
Bigger change from baseline in the intervention group score of the Nijmeegse Ouderlijke Stress Index compared to the no-intervention group.
Questionnaire over Parenting stress index developed in Nijmegen. Scores range from 0 to 738, distributed over two main subscales: parent-related stress and child-related stress. Each subscale is composed of subdomains. The parent-related stress is described by competence, role restriction, attachment, depression, health, social isolation, marital relationship. The child-related stress is described by adaptation, temperament, distractibility, demandingness, positive reinforcement, acceptance. An algorithm converts the subscores and the total score to a descriptive classification of parental stress level. Special norms hold for clinical samples.
Higher values correspond to higher parental stress. A score reduction is a positive outcome, in particular if lower than the no-intervention group.
Measured: outcome at 9 months after entry
Bigger change from baseline in the intervention group score of the Vineland screener questionnaire (0-6 years) compared to the no-intervention group.
Questionnaire to assess adaptive skills. The composite score is computed as the sum of subscale scores: communicative skills (0-38), social skills (0-38), everyday skills (0-16), motor skills (0-36). Raw scores can be converted to adaptive age.
Score stability (after increase) or increase is a positive outcome, in particular if higher than the no-intervention group.
Measured: outcome at 9 months after entry
Difference between intervention and no-intervention group in language.
Language will be investigated with the Dutch adaptation of the MacArthur Communicative Development Inventories (CDI), Words and Gestures (8-18 months) and Words and Sentences (16-30 months), which consists of a parent report of language development (both comprehension and production).
Higher score in the intervention group is considered a positive outcome.
Measured: outcome at 9 months after entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start28 Mar 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 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 DisorderStudies of the same condition, open and under way.
- More trials run by University GhentThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. dr. Herbert Roeyers, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208411
- Sponsor's protocol ID
- 814302 - ONZ-2022-0587
- Acronym
- SAPIENS
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2021
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Parent-mediated Intervention on Social Behaviour and Social Brain Development in Infants at High Risk for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05208411
- Acronym / sponsor ID
- SAPIENS / 814302 - ONZ-2022-0587
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Autism Spectrum Disorder, Siblings, Preterm, Elevated likelihood of ASD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 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.
This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of infants with elevated likelihood of Autism Spectrum Disorder (ASD). The children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and 6 months after its conclusion (follow-up).
Detailed description
Previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (ASD).Considering that several differences in social and non-social skills start to emerge before a diagnosis can be made, this project aims to investigate the effects of an adapted prodromal version of an evidence-based parent-mediated intervention (Project ImPACT) in children with an elevated likelihood to develop ASD (namely siblings and children who were born preterm). The effect of the intervention will be evaluated at both behavioural and neural levels. The intervention is suitable for infants and consists of 12 session with the child and his/her parents, of maximum 2 hours each, one session per week, delivered by therapists of the home guidance and home guidance centers in Flanders. Children between 9 and 18 months old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention group or a no-intervention group (monitoring only). The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 12 weeks) and 24 weeks after the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ImPACT group | Experimental | Behavioral: Project ImPACT: Improving Parents As Communication TeachersGroup of children at elevated likelihood of ASD who will receive the ImPACT intervention |
| No intervention group | No intervention | –Group of children at elevated likelihood of ASD who won't receive any intervention |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elevated likelihood of ASD: the child must be a preterm (less than 30 weeks of gestation) or a sibling/half-sibling of a child with diagnosed ASD.
- Parents are Dutch, English on French speakers.
Key exclusion criteria (1 listed)
- The child must not have a diagnosis of other neurological or developmental disorders.
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 |
|---|---|---|
| Project ImPACT: Improving Parents As Communication TeachersProject ImPACT ("Improving Parents As Communication Teachers", Ingersoll \& Dvortcsak, 2019) is a promising evidence-based parent-mediated intervention that is part of a class of naturalistic, developmental, behavioral interventions (NBDIs). NBDIs involve the use of behavioral principles of learning to teach skills chosen from a developmental sequence in naturalistic play-setting and using natural rewards. Skills selected as relevant for intervention are those that allow the child to participate more fully within reciprocal interactions with the adult. In recent years the program has been adapted for use with infants and toddlers at elevated likelihood of ASD. These adaptations have made this program appropriate for younger children and children who are experiencing social communication delays but do not have an ASD diagnosis. | Behavioural | ImPACT group |
Primary outcome
Bigger change from baseline in the parent-child interaction in the intervention group compared to the no-intervention group.
Time frame: Outcome at 3 months after entry(post-test)
Change in quality and frequency of behaviours (with the same unit of measure) within the Parent-Child Interaction coded through the Parent-Infant/Toddler Coding of Interaction (PInTCI). An increase is considered as a positive outcome.
Bigger change from post-test in the intervention group in the parent-child interaction compared to the no-intervention group.
Time frame: Follow-up at 6 months after post-test
Change in quality and frequency of behaviours (with the same unit of measure) within the Parent-Child Interaction coded through the Parent-Infant/Toddler Coding of Interaction (PInTCI). An increase is considered as a positive outcome.
15 secondary outcomes
Bigger change from baseline in Social Engagement in the intervention group compared to the no-intervention group.
Time frame: outcome at 3 months after entry (post-test)
Bigger change from baseline in the score of imitation in the intervention group compared to the no-intervention group.
Time frame: outcome at 3 months after entry (post-test)
Bigger change from baseline in the score of intentional communication in the intervention group compared to the no-intervention group
Time frame: outcome at 3 months after entry (post-test)
Bigger change from baseline in attention disengagement in the intervention group compared to the no-intervention group
Time frame: outcome at 3 months after entry (post-test)
Bigger change from baseline in the intervention group compared to the no-intervention group in electrophysiological spectral power and connectivity (theta and alpha band) in response to social versus non-social videos, measured with EEG.
Time frame: outcome at 3 months after entry (post-test)
Bigger change from post-test in the intervention group in the score of Social Engagement compared to the no-intervention group.
Time frame: follow-up at 6 months after post-test
Bigger change from post-test in the score of a semi-structured social imitation task compared to the no-intervention group.
Time frame: follow-up at 6 months after post-test
Bigger change from post-test in the score of intentional communication in the intervention group compared to the no-intervention group
Time frame: follow-up at 6 months after post-test
Bigger change from post-test in the intervention group in electrophysiological spectral power and connectivity (theta and alpha band) in response to social versus non-social videos, measured with EEG.
Time frame: follow-up at 6 months after post-test
Bigger change from post-test in attention disengagement in the intervention group compared to the no-intervention group, measured with Eye-tracking
Time frame: follow-up at 6 months after post-test
Difference between intervention and no-intervention group in the severity score of the Autism Diagnostic Observational Scale - 2 (ADOS-2).
Time frame: outcome at 9 months after entry
Bigger change from baseline in the in the intervention group in the score of the Bayley Scales of Infant and Toddler Development - Third Edition - NL compared to the no-intervention group.
Time frame: outcome at 9 months after entry
Bigger change from baseline in the intervention group score of the Nijmeegse Ouderlijke Stress Index compared to the no-intervention group.
Time frame: outcome at 9 months after entry
Bigger change from baseline in the intervention group score of the Vineland screener questionnaire (0-6 years) compared to the no-intervention group.
Time frame: outcome at 9 months after entry
Difference between intervention and no-intervention group in language.
Time frame: outcome at 9 months after entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Prof. dr. Herbert Roeyers, PhD contact
Prof. dr. Herbert Roeyers, PhD study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project ImPACT: Improving Parents As Communication Teachers in people with Autism Spectrum Disorder, run by University Ghent at 1 site in Belgium.
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 2 inclusion and 1 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 27 Nov 2023. 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 Belgium. 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 Dr. Sara Van der Paelt, PhD (+32 486 93 14 48, sara.vanderpaelt@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bigger change from baseline in the parent-child interaction in the intervention group compared to the no-intervention group. (time frame: Outcome at 3 months after entry(post-test)). 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?
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 27 Nov 2023.