Skip to content

A novel Tele-intervention for Autistic Toddlers Devlivered through Caregivers: Is it feasible, accpetable and efficacious?

Development, Feasibility, and Preliminary Efficacy of an online Caregiver-Mediated Early Intervention for Autistic Toddlers: A Feasibility Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110855
Enrollment
36
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: Online Caregiver-mediated Early Intervention for Autistic Toddlers: The manualized CMEI is based on principles of Naturalistic Developmental Behavioural principles targeting caregiver r

Sponsors

National Institute of Mental Health and Neuro Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: At least one caregiver living and spending time with the toddler willing to participate. Participating caregiver must be comfortable communicating in at least one of the following languages: English, Kannada, or Hindi. Caregivers must have access to basic technology, any one of the mentioned devices (desktop/laptop/tablet/smartphone) and stable internet connectivity (Wi-Fi or at least 3G mobile internet) to support video conferencing platforms such as Zoom/Google meet. The caregivers must be willing to share video recordings of their toddler for evaluation of progress.

Exclusion criteria

Exclusion criteria: Toddlers with significant pre-peri-post natal medical history such as known exposure to neurotoxins or specific medication during the gestational period, any genetic conditions or presence of any syndromic features, birth weight or gestational age less than 37 weeks and toddlers with sensory impairments. Participating caregivers with uncorrected sensory impairments (e.g., vision, hearing). Toddler with an older autistic sibling or diagnosed with related developmental disorders.

Design outcomes

Primary

MeasureTime frame
Sensitive responsiveness & attentiveness to the caregiver - Manchester Assessment of Caregiver-Child Interaction (MACI)Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point)

Secondary

MeasureTime frame
Global Scales for Early Development - Short Form Raw score D score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Daily Living Skills Scale Subscale raw score Total raw score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Receptive Expressive Emergent Language Scale- 3 Receptive and expressive language raw score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);MacArthur-Bates Communicative Development Inventory Total Early gestures Total Late gestures Total number of words understood Total number of words understood & said Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Communication and Symbolic Behaviour Scales- Caregiver questionnaire Speech composite weighted raw score Symbolic composite weighted raw scores Social composite weighted raw score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Sensory Processing Measure Preschool (Home form) Total raw score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Repetitive behaviour Scale Early childhood Total raw score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Mini International Neuropsychiatric Interview Screen - 7.0.2 Total score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Manchester Assessment of Caregiver-Child Interaction (MACI): Amount of mutuality raw score Level of mutuality raw score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point);Intervention feasibility and acceptability questionnaire Counts and percentages Timepoint: T2 (post intervention phase) T3 (end point);Parent Stress Scale Total score Timepoint: T1 (baseline) T2 (post intervention phase) T3 (end point)

Countries

India

Contacts

Public ContactDr Shoba Sreenath Meera

National Institute of Mental Health and Neurosciences

shreevolme@gmail.com9481073037

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026