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

Child Development Clinical Trial

Official title:

A Randomized Controlled Trial of Parent-mediated Social-communication Therapy for Young Children at Risk for Neurodevelopmental Difficulties Living in Poverty in Brazil

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05011240
• Other study ID #: 45672321.0.0000.0068
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2021
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Environmental Exposure

Intervention

Behavioral:
• 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.
• Psychoeducation
Control participants will receive monthly psychoeducation sessions led by a developmental specialist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in style of parenting care	Self-reported parenting care style measured by the Parenting Scale	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Other	Change in parent-child joint engagement	Joint interaction behaviors between parent and child during free-play interaction measured with the Joint Engagement Rating Inventory	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Other	Change in developmental ability	Global developmental ability measured by the Ages and Stages Questionnaire completed by primary caregivers.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Primary	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	Change in Socialization and Communication Domain Standardized Scores on the Vineland Adaptive Behavior Scales - 3	Parent-reported measure of children's adaptive social and communication skills	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Secondary	Change in neurophysiological activity during live social interaction	Neurophysiological activity measured with electroencephalography (EEG) during a live play interaction between the child and an examiner	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Secondary	Change in Internalizing and Externalizing Behavior Problems	Internalizing and externalizing behaviour problems measured by parent-report on the Child Behavior Checklist 1.5-5 and on the Strengths and Difficulties Questionnaire 2-4.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Secondary	Child initiations during parent-child interaction	Child initiations 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). Child initiations are coded as the proportion of the child's spontaneous communicative behaviors oriented to the parent, including verbal and non-verbal behaviors.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)