Support of early social-communication development in infants aged 6-11 months with family history of autism and attention-deficit/hyperactivity disorder (ADHD) Mental and Behavioural Disorders
Conditions
Interventions
Participants (infants with elevated familial likelihood of autism, N=100, or with elevated familial likelihood of ADHD, N=100, and their primary caregivers) are randomised to receive the iBASIS-VIPP i
infant age (in month) and sex are controlled to ensure groups differ as little as possible in these characteristics.
iBASIS-VIPP intervention:
The iBASIS-VIPP intervention is a parent-mediated inte
Sponsors
Universidade de São Paulo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/04/2023: Eligible participants are infants and their primary caregivers. Infants must: 1. be aged between 6 months 0 days and 11 months 28 days 2. have either (a) an older sibling or biological parent with autism (diagnosed or suspected) or (b) an older sibling or biological parent with ADHD (diagnosed or suspected) Previous inclusion criteria: Eligible participants are infants and their primary caregivers. Infants must: 1. be aged between 6 months 0 days and 11 months 28 days 2. have either (a) an older sibling with autism (diagnosed or suspected) or (b) an older sibling or biological parent with ADHD (diagnosed or suspected) Added 16/09/2022: Note on criterion 2: the difference in inclusion criteria for the infants with a family history of autism and infants with a family history of ADHD is to remain consistent with previously published studies with infants with a family history of autism and ADHD. That is, while the past work with infants with a family history of ADHD has included infants with an older sibling or parent diagnosed with ADHD, the past work with infants with a family history of autism has only included infants who have an older sibling diagnosed with autism and not a parent diagnosed with autism.
Exclusion criteria
Exclusion criteria: Infants and their primary caregivers will be excluded if: 1. the infant has a known genetic or neurological condition 2. the infant was born with significant prematurity, i.e., born at less than 36 weeks gestation 3. the infant had significant birth complications e.g., asphyxia 4. the infant has uncorrected visual or auditory disability 5. the primary caregiver that would participate in the trial has intellectual disability or serious psychiatric or medical condition that would interfere with the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social-communication ability measured using an examiner-coded play-based interaction assessment (the Communication and Symbolic Behavior Scales) at Time 1 (trial month 0) and Time 2 (trial month 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/04/2023: 1. Parent-child interaction synchrony and parental sensitive responsiveness and non-directiveness measured using the examiner-coded Manchester Assessment of Caregiver-infant Interaction (MACI) from videos of natural interactions of the caregiver and infant at Time 1 (month 0) and Time 2 (month 6) and with the examiner-coded Joint Engagement Rating Inventory (JERI) at Time 3 (at age 24 months) 2. Traits of autism measured using the examiner-coded Autism Diagnostic Observation Scale – 2nd Edition (ADOS-2) and the parent-rated Social Responsiveness Scale – 2nd Edition – Preschool Version at Time 3 3. Traits of attention-deficit/hyperactivity disorder (ADHD) measured using the examiner-coded Behavioral Rating Inventory for Children (BRIC) and the ADHD Coding Project at Time 1, Time 2 and Time 3 and using the parent-rated Child Behavior Checklist (CBCL) at Time 3 4. Self-regulatory ability and executive function measured using the parent-rated Infant Behavior Questionnaire-Revised/Early Childhood Behavior Questionnaire and the examiner-coded Reverse Categorisation, Spin the Pots and Glitter Wand tasks at Time 3 5. Adaptive functioning measured using the Vineland Adaptive Behavior Scales III Parent-Interview at Time 1, Time 2 and Time 3 6. Development of cognitive, language and motor abilities assessed using the examiner-coded Bayley Scales of Infant Development III at Time 1, Time 2 and Time 3 7. Language development measured using the parent-report McArthur-Bates Communication Development Inventories at Time 1, Time 2 and Time 3 8. Parental stress measured with the parent-report Depression, Anxiety and Stress Scale – 21 (DASS-21) at Time 1, Time 2 and Time 3 9. Environmental noise in the family home measured with the Confusion, Hubbub and Order Scale (CHAOS) at Time 1, Time 2 and Time 3 10. Neurodevelopment measured using electroencephalography (EEG) at Time 1, Time 2 and Time 3 Previous secondary outcome measures: 1 | — |
Countries
Brazil
Outcome results
None listed