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

NCT05011240 | Unknown DMC

• 1 other identifier: 45672321.0.0000.0068
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Child Development; Communication, Social; Environmental Exposure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in parent-child interaction synchrony

  Parent-child interaction synchrony will be measured during a 10-minute free-play interaction between the primary caregiver and child and coded using the Dyadic Communication Measure for Autism (DCMA). Synchrony is coded as the proportion of communicative behaviors of the primary caregiver that elicit responses from the child.

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

Secondary Outcomes (4)

• Change in Socialization and Communication Domain Standardized Scores on the Vineland Adaptive Behavior Scales - 3

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

• Change in neurophysiological activity during live social interaction

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

• Change in Internalizing and Externalizing Behavior Problems

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

• Child initiations during parent-child interaction

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

Other Outcomes (3)

• Change in style of parenting care

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

• Change in parent-child joint engagement

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

• Change in developmental ability

  Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Paediatric Autism Communication Therapy (PACT)

Community support as usual plus psychoeducation (Control)

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation

Interventions

Paediatric Autism Communication Therapy (PACT) 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.

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

Psychoeducation BEHAVIORAL

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

Community support as usual plus psychoeducation (Control)

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Related Publications (1)

• 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.

  PMID: 35506888 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Preventative Medicine

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 18, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share