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Child DevelopmentNCT05011240

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

A study testing Paediatric Autism Communication Therapy (PACT) and Psychoeducation in people with Child Development and Communication, Social, run by Faculdade de Medicina do ABC.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 24 to 59 months
What is being tested?
Paediatric Autism Communication Therapy (PACT) and Psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Being tested
Paediatric Autism Communication Therapy (PACT), Psychoeducation
Keywords
Preventative intervention, Early child development, Social communication development, Socioeconomic disadvantage, Randomized Controlled Trial
Medical subject headings
Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paediatric Autism Communication Therapy (PACT)Behavioural

    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.

  • PsychoeducationBehavioural

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

Study groups in NCT05011240
Study groupRoleWhat they receive
Paediatric Autism Communication Therapy (PACT) Intervention plus Community Assistance as UsualExperimentalParticipants will receive 12 sessions over 5 months of Paediatric Autism Communication Therapy (PACT).
Receives: Behavioral: Paediatric Autism Communication Therapy (PACT)
Community support as usual plus psychoeducation (Control)Active comparatorParticipants 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.
Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. 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

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

  2. 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

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011240
Sponsor's protocol ID
45672321.0.0000.0068
Status last verified
Nov 2021
First submitted
16 Aug 2021
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35506888

Questions about this trial

What is this clinical trial studying?

A study testing Paediatric Autism Communication Therapy (PACT) and Psychoeducation in people with Child Development and Communication, Social, run by Faculdade de Medicina do ABC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in parent-child interaction synchrony (time frame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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