ImPACT Intervention for Children With ASD

NCT03323918 | Completed

• 1 other identifier: BRAINVIEW/ESR14
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (10)

• 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.

  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  Unpublished task developed by B. Ingersoll, author of the ImPACT intervention programme.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.

  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.

  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).

  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.

  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.

  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.

  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.

  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).

  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.

  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)

  follow-up at 30 weeks from beginning of intervention

• Change from baseline in the score of the Mullen Scales of Early Learning (M-SEL)

  follow-up at 30 weeks from beginning of intervention

• Change from baseline in the score of the Vineland screener questionnaire (0-6 years).

  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)

  outcome at 18 weeks from start of intervention (post-test)

• Change from baseline in the score of the Nijmeegse Ouderlijke Stress Index

  outcome at 18 weeks from start of intervention (post-test)

Study Arms (2)

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.

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.

Other: TAU

Interventions

ImPACT OTHER

Teaching parents to train social communicative skills as outlined in arm description.

ImPACT

TAU OTHER

TAU can include targeting eating and sleeping problems, adaptive skills, or other goals.

Also known as: Treatment as usual

TAU

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A clinical or working diagnosis of ASD

Sponsors & Collaborators

• University Ghent: lead
• European Union: collaborator

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Herbert Roeyers, Prof. dr.

  UGent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators who are involved in the testing sessions and data analysis are blind to group assignment. An investigator which is not directly involved in participant testing or data analysis takes care of the randomisation, and coordinates it with the home guidance centers that administer the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 27, 2017
• Study Start: November 1, 2016
• Primary Completion: November 28, 2021
• Study Completion: November 28, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)