Autism Spectrum DisorderNCT03323918
ImPACT Intervention for Children With ASD
A study testing ImPACT and TAU 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 preschoolers with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 18 to 48 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ImPACT and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2016to 28 Nov 2021
- 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 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical or working diagnosis of ASD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent-implemented Intervention for Children With ASD: Effect on Social Communication and Brain Activation
This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of preschoolers with 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 several weeks 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). The aim of the present project is to investigate the brain activity changes that are at the basis of the changes observed in the children's behaviour. More specifically, the investigators will assess the effect of Project ImPACT, a parent-implemented intervention, which teaches parents techniques to stimulate the social-communicative abilities of their children.
The intervention is suitable for preschoolers with a diagnosis of ASD and consists of 18 sessions of maximum 2 hours each, one session per week, delivered by trained therapists of the home guidance services in Flanders. Children with a diagnosis of ASD (or children who are suspected of ASD) between 1,5 and 4 years old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention or treatment as usual. The investigators will assess the effect of the intervention on the children's social-communicative abilities, and on the neural and biological correlates of these abilities.
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 18 weeks) and 12 weeks after the end of the intervention.
- Conditions
- Autism Spectrum Disorder
- Being tested
- ImPACT, TAU
- 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.
ImPACTOther
Teaching parents to train social communicative skills as outlined in arm description.
TAUOther
Also called Treatment as usual
TAU can include targeting eating and sleeping problems, adaptive skills, or other goals.
| Study group | Role | What they receive |
|---|---|---|
| ImPACT | Experimental | Project ImPACT will be provided in 18 weekly intervention sessions, during which parents will learn how to stimulate their children's social imitation, social engagement, language and play skills. First, parents are taught techniques that promote interaction with the child (one technique per session, through demonstration and coaching). In the second half of the intervention, parents are taught direct teaching techniques, e.g., to promote language or play, again by means of demonstration and coaching. After completion of the program, families will receive guidance every 2-3 weeks for an additional 12 weeks, during which the support will generally not focus on social-communicative abilities, although ImPACT follow-up sessions might be given if necessary. Receives: Other: ImPACT |
| TAU | Active comparator | Treatment as usual (TAU) will be provided at the typical frequency, which is every 2-3 weeks. TAU can include targeting eating and sleeping problems, adaptive skills, or other goals. TAU will not include forms of intervention explicitly targeting social communicative skills. However, limited guidance on social communication development can be given if explicitly asked by parents. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the score of the Early Social Communication Scales (ESCS)
Structured observation of interaction with experimenter assessing joint attention. The measure includes continuous measurement of initiation of joint attention (IJA) and behavioural requests (IBR). The measurement of response to joint attention (RJA) is constrained by the numbered of joint attention bids offered by the administer, which is 14 in total. The IJA, IBR, and RJA subsections are considered separately, and the three scores are not combined. An increase in the IJA and RJA scores is interpreted as an improvement. A decrease in IBR, if combined with an increase of IJA, is generally also interpreted as a qualitative improvement of a child's social initiatives.
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in the score of a semi-structured social imitation task
Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is in use. 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 18 weeks from start of intervention (post-test)
Change from baseline in the score of the Brief Observation of Social Communication Change (BOSCC)
Semi-structured observation of interaction with parent and experimenter to assess social communication.
The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behaviour, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behaviour, and anxious behaviours.
The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information.
In the total and subscale scores, higher scores correspond to more severe symptoms. A decrease in the total score is thus considered a positive outcome.
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
EEG activity will be recorded while children watch silent movies and passively listen to voice and non-voice sounds (passive oddball paradigm).
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
Oxy- and deoxyhaemoglobin concentration measured during a task in which an experimenter establishes social and non-social attention conditions while children watch fragments of age-appropriate cartoons.
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from post-test in the score of the Early Social Communication Scales (ESCS)
Structured observation of interaction with experimenter assessing joint attention. The measure includes continuous measurement of initiation of joint attention (IJA) and behavioural requests (IBR). The measurement of response to joint attention (RJA) is constrained by the numbered of joint attention bids offered by the administer, which is 14 in total. The IJA, IBR, and RJA subsections are considered separately, and the three scores are not combined.
Stability (after increase at outcome) or increase in the IJA and RJA scores is interpreted as an improvement. A decrease in IBR, if combined with an increase of IJA, is generally also interpreted as a qualitative improvement of a child's social initiatives.
Measured: follow-up at 12 weeks from end of intervention
Change from post-test in the score of a semi-structured social imitation task
Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is in use. 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 12 weeks from end of intervention
Change from post-test in the score of the Brief Observation of Social Communication Change (BOSCC).
Semi-structured observation of interaction with parent and experimenter to assess social communication. The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behaviour, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behaviour, and anxious behaviours. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms. Score stability (after decrease at outcome) or decrease is a positive outcome.
Measured: follow-up at 12 weeks from end of intervention
Change from post-test in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
EEG activity recorded while children watch silent movies and passively listen to voice and non-voice sounds (passive oddball paradigm).
Measured: follow-up at 12 weeks from end of intervention
Change from post-test in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
Oxy- and deoxyhaemoglobin concentration measured during a task in which an experimenter establishes social and non-social attention conditions while children watch fragments of age-appropriate cartoons.
Measured: follow-up at 12 weeks from end of intervention
Secondary outcomes (8)
Change from baseline in the 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-dependednt 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 reduction in the total score, as well as in a subscale score, is considered a positive outcome, particularly if this leads to a decrease in the conversion score and/or to a milder diagnostic classification.
Measured: follow-up at 30 weeks from beginning of intervention
Change from baseline in the score of the Mullen Scales of Early Learning (M-SEL)
An age-appropriate measure of cognitive development. It measures a child's IQ on a continuous scale from 49 to 130 points, with the average being 100 points. If the child's IQ is lower than 49 or higher than 130, a general indication of <49 or >130 is given. It also provides an indication of a child's mental age between 0 and 68 months. A growth in mental age over time is considered a neutral outcome. 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: follow-up at 30 weeks from beginning of intervention
Change from baseline in the score of the Vineland screener questionnaire (0-6 years).
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 increase is a positive outcome.
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)
Parent report of language development (questionnaire). The questionnaire consists of two subsection: a) number of comprehended words (out of 112), b) number of actively used words (out of 112). The two subscales are kept separate, and no composite score is computed.
The section in use is the 2A section, which is meant for children between 16 and 30 months. Because a number of children in the study are older than 30 months, only the raw scores are taken into account.
Score increase is considered a positive outcome.
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in the score of the Nijmeegse Ouderlijke Stress Index
Questionnaire over Parenting stress index developed in Nijmegen. Scores range from 0 to 738, distributed over two main subscales: parent-related stress, maximum score 390, and child-related stress, maximum score 348. Each subscale is composed of subdomains. The parent-related stress is described by competence (0-78), role restriction (0-42), attachment (0-42), depression (0-72), health (0-36), social isolation (0-36), marital relationship (0-42). The child-related stress is described by adaptation (scores: 0-78), temperament (0-60), distractability (0-72), demandingness (0-60), positive reinforcement (0-48), acceptance (0-72). An algorithm converts the subscores and the total score to a descriptive classification of parental stress level (very low, low, below average, average, above average, high, very high). Special norms hold for clinical samples.
Higher values correspond to higher parental stress. A score reduction is a positive outcome.
Measured: outcome at 18 weeks from start of intervention (post-test)
Change from post-test in the score of the Vineland screener questionnaire (0-6 years).
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.
Measured: follow-up at 12 weeks from end of intervention
Change from post-test in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)
Parent report of language development (questionnaire). The questionnaire consists of two subsection: a) number of comprehended words (out of 112), b) number of actively used words (out of 112). The two subscales are kept separate, and no composite score is computed.
The section in use is the 2A section, which is meant for children between 16 and 30 months. Because a number of children in the study are older than 30 months, only the raw scores are taken into account.
Score stability (after increase at outcome) or increase is considered a positive outcome.
Measured: follow-up at 12 weeks from end of intervention
Change from post-test in the score of the Nijmeegse Ouderlijke Stress Index
Questionnaire over Parenting stress index developed in Nijmegen. Scores range from 0 to 738, distributed over two main subscales: parent-related stress, maximum score 390, and child-related stress, maximum score 348. Each subscale is composed of subdomains. The parent-related stress is described by competence (0-78), role restriction (0-42), attachment (0-42), depression (0-72), health (0-36), social isolation (0-36), marital relationship (0-42). The child-related stress is described by adaptation (scores: 0-78), temperament (0-60), distractability (0-72), demandingness (0-60), positive reinforcement (0-48), acceptance (0-72). An algorithm converts the subscores and the total score to a descriptive classification of parental stress level (very low, low, below average, average, above average, high, very high). Special norms hold for clinical samples.
Higher values correspond to higher parental stress. A score reduction is a positive outcome.
Measured: follow-up at 12 weeks from end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study startNov 2016
- Primary completion28 Nov 2021
- Study completion28 Nov 2021
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
- Model description
- Group 1 will receive the intervention specifically targeting social-communicative abilities (Project ImPACT). Group 2 will receive a generic intervention, that will not focus on social-communicative skills.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Herbert Roeyers, Prof. dr., Principal investigator, UGent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323918
- Sponsor's protocol ID
- BRAINVIEW/ESR14
- Status last verified
- Nov 2022
- First submitted
- 2 Oct 2017
- Last updated
- 9 Nov 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-implemented Intervention for Children With ASD: Effect on Social Communication and Brain Activation
- ClinicalTrials.gov ID
- NCT03323918
- Acronym / sponsor ID
- BRAINVIEW/ESR14
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Nov 2016 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 27 Oct 2017 (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 preschoolers with 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 several weeks 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). The aim of the present project is to investigate the brain activity changes that are at the basis of the changes observed in the children's behaviour. More specifically, the investigators will assess the effect of Project ImPACT, a parent-implemented intervention, which teaches parents techniques to stimulate the social-communicative abilities of their children.
The intervention is suitable for preschoolers with a diagnosis of ASD and consists of 18 sessions of maximum 2 hours each, one session per week, delivered by trained therapists of the home guidance services in Flanders. Children with a diagnosis of ASD (or children who are suspected of ASD) between 1,5 and 4 years old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention or treatment as usual. The investigators will assess the effect of the intervention on the children's social-communicative abilities, and on the neural and biological correlates of these abilities.
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 18 weeks) and 12 weeks after the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1 will receive the intervention specifically targeting social-communicative abilities (Project ImPACT). Group 2 will receive a generic intervention, that will not focus on social-communicative skills.
| Arm | Type | Receives |
|---|---|---|
| ImPACT | Experimental | Other: ImPACTProject ImPACT will be provided in 18 weekly intervention sessions, during which parents will learn how to stimulate their children's social imitation, social engagement, language and play skills. First, parents are taught techniques that promote interaction with the child (one technique per session, through demonstration and coaching). In the second half of the intervention, parents are taught direct teaching techniques, e.g., to promote language or play, again by means of demonstration and coaching. After completion of the program, families will receive guidance every 2-3 weeks for an additional 12 weeks, during which the support will generally not focus on social-communicative abilities, although ImPACT follow-up sessions might be given if necessary. |
| TAU | Active comparator | Other: TAUTreatment as usual (TAU) will be provided at the typical frequency, which is every 2-3 weeks. TAU can include targeting eating and sleeping problems, adaptive skills, or other goals. TAU will not include forms of intervention explicitly targeting social communicative skills. However, limited guidance on social communication development can be given if explicitly asked by parents. |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A clinical or working diagnosis of ASD
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ImPACTTeaching parents to train social communicative skills as outlined in arm description. | Other | ImPACT |
| TAUAlso: Treatment as usualTAU can include targeting eating and sleeping problems, adaptive skills, or other goals. | Other | TAU |
Primary outcome
Change from baseline in the score of the Early Social Communication Scales (ESCS)
Time frame: outcome at 18 weeks from start of intervention (post-test)
Structured observation of interaction with experimenter assessing joint attention. The measure includes continuous measurement of initiation of joint attention (IJA) and behavioural requests (IBR). The measurement of response to joint attention (RJA) is constrained by the numbered of joint attention bids offered by the administer, which is 14 in total. The IJA, IBR, and RJA subsections are considered separately, and the three scores are not combined. An increase in the IJA and RJA scores is interpreted as an improvement. A decrease in IBR, if combined with an increase of IJA, is generally also interpreted as a qualitative improvement of a child's social initiatives.
Change from baseline in the score of a semi-structured social imitation task
Time frame: outcome at 18 weeks from start of intervention (post-test)
Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is in use. The score ranges from 0 to 20, with higher scores corresponding to higher social imitation rates. Score increase is a positive outcome.
Change from baseline in the score of the Brief Observation of Social Communication Change (BOSCC)
Time frame: outcome at 18 weeks from start of intervention (post-test)
Semi-structured observation of interaction with parent and experimenter to assess social communication. The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behaviour, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behaviour, and anxious behaviours. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms. A decrease in the total score is thus considered a positive outcome.
Change from baseline in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
Time frame: outcome at 18 weeks from start of intervention (post-test)
EEG activity will be recorded while children watch silent movies and passively listen to voice and non-voice sounds (passive oddball paradigm).
Change from baseline in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
Time frame: outcome at 18 weeks from start of intervention (post-test)
Oxy- and deoxyhaemoglobin concentration measured during a task in which an experimenter establishes social and non-social attention conditions while children watch fragments of age-appropriate cartoons.
Change from post-test in the score of the Early Social Communication Scales (ESCS)
Time frame: follow-up at 12 weeks from end of intervention
Structured observation of interaction with experimenter assessing joint attention. The measure includes continuous measurement of initiation of joint attention (IJA) and behavioural requests (IBR). The measurement of response to joint attention (RJA) is constrained by the numbered of joint attention bids offered by the administer, which is 14 in total. The IJA, IBR, and RJA subsections are considered separately, and the three scores are not combined. Stability (after increase at outcome) or increase in the IJA and RJA scores is interpreted as an improvement. A decrease in IBR, if combined with an increase of IJA, is generally also interpreted as a qualitative improvement of a child's social initiatives.
Change from post-test in the score of a semi-structured social imitation task
Time frame: follow-up at 12 weeks from end of intervention
Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme. Semi-structured observation of interaction with experimenter. Only the object scale is in use. 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.
Change from post-test in the score of the Brief Observation of Social Communication Change (BOSCC).
Time frame: follow-up at 12 weeks from end of intervention
Semi-structured observation of interaction with parent and experimenter to assess social communication. The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behaviour, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behaviour, and anxious behaviours. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms. Score stability (after decrease at outcome) or decrease is a positive outcome.
Change from post-test in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
Time frame: follow-up at 12 weeks from end of intervention
EEG activity recorded while children watch silent movies and passively listen to voice and non-voice sounds (passive oddball paradigm).
Change from post-test in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
Time frame: follow-up at 12 weeks from end of intervention
Oxy- and deoxyhaemoglobin concentration measured during a task in which an experimenter establishes social and non-social attention conditions while children watch fragments of age-appropriate cartoons.
8 secondary outcomes
Change from baseline in the score of the Autism Diagnostic Observational Scale - 2 (ADOS-2)
Time frame: follow-up at 30 weeks from beginning of intervention
Change from baseline in the score of the Mullen Scales of Early Learning (M-SEL)
Time frame: follow-up at 30 weeks from beginning of intervention
Change from baseline in the score of the Vineland screener questionnaire (0-6 years).
Time frame: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)
Time frame: outcome at 18 weeks from start of intervention (post-test)
Change from baseline in the score of the Nijmeegse Ouderlijke Stress Index
Time frame: outcome at 18 weeks from start of intervention (post-test)
Change from post-test in the score of the Vineland screener questionnaire (0-6 years).
Time frame: follow-up at 12 weeks from end of intervention
Change from post-test in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)
Time frame: follow-up at 12 weeks from end of intervention
Change from post-test in the score of the Nijmeegse Ouderlijke Stress Index
Time frame: follow-up at 12 weeks from end of intervention
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 9 Nov 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.
Herbert Roeyers, Prof. dr. principal investigator
UGent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImPACT and TAU 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 1 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: finished, as of the sponsor's last update on 9 Nov 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 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?
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?
Change from baseline in the score of the Early Social Communication Scales (ESCS) (time frame: outcome at 18 weeks from start of intervention (post-test)). The study lists 10 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 9 Nov 2022.