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Parent-mediated Social-communication Therapy for Young Children Living in Poverty in Brazil

NCT ID: NCT05011240

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-01

Brief Summary

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Exposure to adverse environments such as socioeconomic disadvantage and psychosocial deprivation are risk-factors for neurodevelopmental problems in childhood. Children exposed to such environments may benefit from interventions that target social-communication abilities, since these skills act as protective factors for healthy neurodevelopment in vulnerable children. One early childhood intervention that has shown efficacy in improving early social-communication development is Paediatric Autism Communication Therapy (PACT). However, there are no studies testing the efficacy of PACT in Latin American countries where environmental risk factors are common. This randomized controlled trial will test the efficacy of PACT in improving social-communication development in young children at risk for neurodevelopmental difficulties due to living in socio-economically disadvantaged regions of São Paulo, Brazil.

Methods: Participants will be 160 children aged 2 years 0 months to 4 years 11 months with low social-communication abilities and their primary caregivers. Child-caregiver dyads will be recruited from public early childhood education centers in impoverished urban regions of the city of São Paulo, Brazil. Low social-communication abilities will be defined by Standard Scores \<84 on the Socialization and/or Communication domains of the Vineland Adaptive Behavior Scales. Child-caregiver dyads will be randomized to receive 12 sessions (five months) of the PACT intervention (N=80) or five months of community support as usual plus psychoeducation (N=80). The primary outcome (parent-child interaction) and secondary outcomes (social-communication abilities assessed with the Vineland, neurophysiological activity during a live social interaction) will be measured pre- and post-intervention. All procedures will be performed in accordance with the CONSORT declaration for non-pharmacological interventions.

Detailed Description

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Conditions

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Child Development Communication, Social Environmental Exposure

Keywords

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Preventative intervention Early child development Social communication development Socioeconomic disadvantage Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The study will be single-blinded with the researchers conducting and coding the outcome measures unaware of the intervention/control status of the study participants.

Study Groups

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Paediatric Autism Communication Therapy (PACT) Intervention plus Community Assistance as Usual

Participants will receive 12 sessions over 5 months of Paediatric Autism Communication Therapy (PACT).

Group Type EXPERIMENTAL

Paediatric Autism Communication Therapy (PACT)

Intervention Type BEHAVIORAL

PACT is a parent-mediated therapy that aims to improve children's social-communication development. During PACT, a therapist uses video-feedback of parent-child play interactions to coach the parent in how to improve their sensitivity and responsiveness to their child's social-communication and interaction behaviours and to implement evidence-based strategies that facilitate social-communication development.

Community support as usual plus psychoeducation (Control)

Participants in the Control group will receive psycho-educational support via monthly sessions led by researchers with experience in child development. In each session, a presentation will be delivered to provide parents with information about child development and environmental factors that contribute to healthy child development, including sensitive parenting styles, frequent positive social interactions between parents and children and cognitive stimulation. The presentations will be followed by group discussions. Children will also continue to receive Community Assistance as Usual via their normal early education centers. These centers offer daily activities designed to promote children's learning, autonomy, movement, integration and socialization. Children attend their educational center five days per week between the hours of 8am and 5pm.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

Control participants will receive monthly psychoeducation sessions led by a developmental specialist

Interventions

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Paediatric Autism Communication Therapy (PACT)

PACT is a parent-mediated therapy that aims to improve children's social-communication development. During PACT, a therapist uses video-feedback of parent-child play interactions to coach the parent in how to improve their sensitivity and responsiveness to their child's social-communication and interaction behaviours and to implement evidence-based strategies that facilitate social-communication development.

Intervention Type BEHAVIORAL

Psychoeducation

Control participants will receive monthly psychoeducation sessions led by a developmental specialist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 2 years 0 months to 4 years 11 months
* low social-communication abilities indexed by Standardized Scores between 55 to 84 on the Socialization and/or Communication Domains of the Vineland Adaptive Behavior Scales - Third Edition
* parent/primary caregiver agrees to participate in the trial

Exclusion Criteria

* known neurological condition such as epilepsy
* known genetic disorder such as Down Syndrome
* hearing or visual impairment in the parent or child that could interfere with the intervention
* self-reported current psychiatric or neurological disorder in the parent that could interfere with the intervention
Minimum Eligible Age

24 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Medicina do ABC

OTHER

Sponsor Role lead

Responsible Party

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Alicia Matijasevich

Associate Professor in Preventative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Godoy PBG, Shephard E, Argeu A, Silveira LR, Salomone E, Aldred C, Green J, Polanczyk GV, Matijasevich A. Social communication therapy for children at risk for neurodevelopmental difficulties: Protocol for a clinical trial. Ann N Y Acad Sci. 2022 Aug;1514(1):104-115. doi: 10.1111/nyas.14784. Epub 2022 May 4.

Reference Type DERIVED
PMID: 35506888 (View on PubMed)

Other Identifiers

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45672321.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id