Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder

NCT06512649 | Recruiting

• 1 other identifier: 94-7
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

H1The primary goal of this intervention study is to learn if very early parent-mediated intervention in children at risk for neurodevelopmental disorders in the first year of life can be implemented in routine care, positively impacting early sensory-motor and socio-communicative developmental trajectories and reducing the developmental gap in children with signs of concern. H2: It is here postulated that early intervention with active parental involvement can reduce parental stress, as well as improve parental understanding and responsiveness to the child's communication cues. H3: An important part of our work will be analysing data about early social and joint attention behaviours in recruited children and comparing them at different time points. The hypothesis is to find early differences between groups at baseline and to detect a change before and after the intervention. For this reason, in our study design, we decided to use technologies to collect data on quantitative measures during play-structured and laboratory sessions to understand changes in developmental trajectories. H4: Given the potential role of genetic and immunological mechanisms in ASD, one of the study's secondary aims is to investigate the impact of an early intervention programme on epigenetic changes and inflammatory and immune response. After enrolment and baseline assessments (T0), children will be allocated to the three groups:

• Group 1 - Clinical Monitoring Group (CM): Siblings of TD children subjects with no signs of concern
• Group 2 - Active Monitoring Group (AM): Siblings of ASD children with no signs of concern
• Group 3 - Early Intervention Group (EI): Siblings classified as "with signs of concern" at baseline evaluation. All children will be re-evaluated after 6 months (T1) and after 12 months (T2).

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Griffiths Scales of Child Development, 3rd Edition (Griffiths-3)

  Griffiths-3 is the gold standard to provide an overall measure of a child's development (0-6 years); it permits the definition of an individual profile of strengths and needs of the child across five areas: foundations of learning, language and communication, eye and hand coordination, personal-social-emotional, gross motor UNIT OF MEASURE: Developmental quotients (range 20-150, normality 85-115)

  T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)

• Communication and Symbolic Behaviour Scales - Infant-Toddler Checklist (CSBS-IT-C)

  is a tool for developmental screening, designed to measure 7 language predictors in children 6 to 24 months of age. The questions of the checklist may be presented in an interview format with adequate explanations to clarify what is being asked. It takes about 5 to 10 minutes to complete and permits the detection of signs of concern for ASD in infants and toddlers UNIT OF MEASURE: weighted score, number: range 3-17; no concern \> 7

  T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)

• Early Social Communication Scale (Échelle de la Communication Sociale Précoce, Italian adaptation, ECSP-I)

  the ECSP-I is a structured assessment designed to provide measures of individual differences in nonverbal communication skills in children from 3 to 30 months of age. The administration requires 15-20 min involving the presentation of approximately 23 standardised situations which provide opportunities for social communication. The ECSP-I demonstrates strong reliability and both construct and discriminant validity Unit of measure: number. Optimal and average level (mean, range 1-4).

  T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)

• Satisfaction Survey

  Parents of children in Groups 2 and 3 will also be asked to anonymously complete a satisfaction survey (created ad hoc for this project) immediately after the intervention to assess their satisfaction with the services provided. The questionnaire takes 5 minutes to complete. unit of measure: likert scale, range 0-5

  T1 (T0 + 6 months)

Secondary Outcomes (13)

• Vineland Adaptive Behaviour Scales-II - Second Edition (Vineland-II)

  T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)

• Questionnaire Sensory Profile - Second Edition (SP-2)

  T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)

• McArthur-Bates questionnaire, child's first vocabulary (PVB) - gestures and words

  T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)

• Infant Behavior Questionnaire-Revised (IBQ-R) and Early Childhood Behavior Questionnaire (ECBQ)

  T0 (recruitment); T2 (T0 + 12 months)

• Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)

  T2 (T0 + 12 months)

Study Arms (3)

Early Intervention Group

EXPERIMENTAL

ASD and typical siblings with Signs of concern

Behavioral: Early intervention

Clinical Monitoring Group

NO INTERVENTION

Typical siblings with no signs of concern Children allocated to this arm will undergo to re-assessment at T1 and T2

Active monitoring Group

EXPERIMENTAL

ASD siblings, no signs of concern

Behavioral: Active monitoring

Interventions

Early intervention BEHAVIORAL

90-minute parent-coaching session once a week for 6 months with an expert developmental therapist, supported by a child neuropsychiatrist or psychologist. A parent will always be present and actively involved in the intervention. The intervention is individualized and tailored to each child's needs and identifies with caregivers the ways to embody objectives in daily life.

Early Intervention Group

Active monitoring BEHAVIORAL

90-minute session once a month for 6 months. Sessions will be performed by an expert developmental therapist, supported by a child neuropsychiatrist or psychologist. A parent will always be present and actively involved in the intervention.

Active monitoring Group

Eligibility Criteria

• Age: 6 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age at recruitment less than or equal to 8 months.
• Sibling diagnosed with autism spectrum disorder
• Normal neurological examination

You may not qualify if:

• Focal neurological signs/symptoms or suspicion of genetic-metabolic disorders
• Genetically determined suspected or known conditions in brother/sister
• Significant familial language barrier

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• University of Milano Bicocca: collaborator
• Politecnico di Milano: collaborator
• Catholic University of the Sacred Heart: collaborator
• University of Turin, Italy: collaborator

Study Sites (1)

Santa Maria Nascente

Milan, 20148, Italy

RECRUITING

Related Publications (19)

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• Whittingham K, McGlade A, Kulasinghe K, Mitchell AE, Heussler H, Boyd RN. ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder. BMJ Open. 2020 Aug 20;10(8):e034315. doi: 10.1136/bmjopen-2019-034315.

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• Annunziata S, Purpura G, Piazza E, Meriggi P, Fassina G, Santos L, Ambrosini E, Marchetti A, Manzi F, Massaro D, Tacci AL, Bolognesi E, Agostini S, La Rosa F, Pedrocchi APG, Molina P, Cavallini A. Early Recognition and Intervention in SIBlingS at High Risk for Neurodevelopment Disorders (ERI-SIBS): a controlled trial of an innovative and ecological intervention for siblings of children with autism spectrum disorder. Front Pediatr. 2025 Jan 6;12:1467783. doi: 10.3389/fped.2024.1467783. eCollection 2024.

  PMID: 39834490 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Chiara Fanciullacci

CONTACT

0039055 7393653; ctu@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 22, 2024
• Study Start: May 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-05

Locations

IT (1)