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A clinical trial to assess the effectiveness and barriers to implementation of Paediatric Autism Communication Therapy (PACT) in the Brazilian public health system

A hybrid effectiveness-implementation study of Paediatric Autism Communication Therapy (PACT) in the Brazilian public health system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13161676
Enrollment
252
Registered
2025-12-16
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Improvement of social communication development and caregiver-child interaction in autistic children and their primary caregivers attending public healthcare services in Brazil Mental and Behavioural Disorders

Interventions

This is a type I hybrid effectiveness-implementation trial, designed to test the clinical effectiveness of PACT in the Brazilian public health service while collecting data on implementation barriers

Sponsors

University of Sao Paulo
Lead Sponsor

Eligibility

Sex/Gender
All
Age
24 Months to 131 Months

Inclusion criteria

Inclusion criteria: Participants of this study will be healthcare professionals and managers of Brazilian public health services that offer support to young autistic children, as well as autistic children and their primary caregivers who are attended at these services. Eligible services will be those that: 1. Offer clinical support to autistic children delivered by clinical psychologists, speech therapists and/or occupational therapists; 2. Those that represent sociodemographic and cultural diversity across the five regions of Brazil. Healthcare professionals will be considered eligible if they: 1. Have permanent contracts with the services; 2. Already work using any clinical intervention with autistic children. Autistic children attended at the public health services will be considered eligible for inclusion in the trial if they: 1. Hold a diagnosis of autism or present signs of autism or social communication difficulties (as established by the service's standard assessments); 2. Are aged 2 years 0 months to 10 years 11 months at the point of recruitment (the age-range for PACT); 3. Their primary caregiver agrees to participate in the trial.

Exclusion criteria

Exclusion criteria: Public healthcare services will be excluded if they: 1. Do not offer supports for autistic children; 2. Are temporary services; 3. Depend on research funding for provision of autism interventions. Healthcare professionals will be excluded if: 1. They have no experience of working with autistic children; 2. They do not wish to receive training in and deliver PACT in the healthcare service. Caregiver-child dyads will be excluded from the study if: 1. They do not wish to receive PACT.

Countries

Brazil

Contacts

Public ContactPriscilla Godoy
pri.bgg@gmail.com+55 1130914185

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026