Pilot Study to Improve Access to Early Intervention for Autism in Africa
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This Mentored Career Development Award will lay the foundation for a career focused on
      addressing two Grand Challenges in Global Mental Health priorities: 1) improving child access
      to evidence-based mental health care, and 2) reducing the duration of untreated illness by
      developing culturally-sensitive early interventions. The proposed research aims to assess
      implementation barriers and facilitators as well as the impact of a brief caregiver coaching
      early autism intervention adapted for use in a low resource setting. Data from this pilot
      study would inform scalable early autism intervention programs for implementation in
      underserved, low resource, and low-literacy populations globally.
    

Detailed description: 
      In this proposal, the investigator's aim is to adapt the caregiver coaching version of the
      Early Start Denver Model (P-ESDM) and conduct a pilot study to explore the impact of this
      adapted intervention on child and caregiver outcomes in an African setting as well as
      understand key facilitators and barriers to implementation of the intervention in this
      setting. Importantly, this work aligns with an objective of the Federal Interagency Autism
      Coordinating Committee Strategic Plan: to support community-based studies that assess the
      effectiveness of interventions in broader community settings including scalable early
      intervention programs for implementation in underserved, low-resource, and low-literacy
      populations. The Early Start Denver Model (ESDM) was the first empirically-validated
      comprehensive intervention for toddlers with Autism Spectrum Disorders (ASD). In a study of
      P-ESDM that parallels the proposed study, Vismara et al (2009) demonstrated that in a brief
      12 week, 1 hour per week, P-ESDM program with parents of toddlers with ASD, all but one
      parent in the study acquired mastery of the ESDM techniques at or above the 85 percent
      criterion by the fifth to sixth intervention session as measured by the ESDM fidelity scale.
      Furthermore, high levels of correct implementation of the ESDM techniques were maintained at
      follow-up for those parents who met fidelity and completed the program, with average percent
      accuracy ranging from 93-97%. The brief intervention also resulted in sustained positive
      growth in child social communicative behaviors. More recently, in an NIH-funded randomized
      controlled trial (RCT), Rogers et al (2012) found that both P-ESDM and community
      interventions were associated with increases in language and cognitive outcomes and decrease
      in ASD symptoms, despite the fact that the community intervention involved a greater number
      of intervention hours. Specifically, a 10-point increase in verbal developmental quotient
      (DQ), a 4-5 point increase in overall DQ, and a decrease in social affect symptoms on the
      Autism Diagnostic Observational Schedule (ADOS) were found. Moreover, the intervention
      resulted in lower levels of parenting stress.

      The site of the proposed study is the Center for Autism Research in Africa at the University
      of Cape Town (Director, Prof Petrus de Vries). South Africa offers a unique opportunity to
      study interactions among treatment, child, family, community and context, which act as
      facilitators or barriers of intervention implementation, thus providing preliminary
      information that could help match the right treatment to the right child and family. In a
      recent multisite P-ESDM RCT Estes and colleagues reported that that this parent coaching
      intervention helped to maintain parental adjustment directly after a child was diagnosed with
      ASD. However, the numbers of negative life events were a significant predictor of parenting
      stress and sense of competence. Child and caregiver factors, particularly prevalent in South
      Africa (eg. poverty, malnutrition, HIV/AIDS), are known to affect child cognitive and
      social-emotional development, as well as parenting stress. Gathering data on the feasibility
      and impact of a scalable early ASD intervention in an environment where other significant
      child and caregiver contextual challenges exist, offers a unique opportunity to examine
      broader contextual factors affecting intervention implementation. The investigator will
      therefore document the effects of broader contextual factors (for e.g. caregiver mental
      health, negative life events, HIV/AIDS, and poverty) on treatment impact. In addition, this
      study will further the understanding of how to implement mental health early interventions in
      a low and middle-income country (LMIC) context, by examining processes used to train and
      supervise non-specialist providers who will provide the caregiver coaching in this context.

      The long term goal of this proposal is to advance understanding of affordable, sustainable
      early intervention strategies for developmental disorders, including ASD that would benefit
      all families regardless of resource availability.

      Specific Aim #1: Adapt the P-ESDM treatment manual and training approach. P-ESDM is a brief,
      scalable caregiver-mediated early autism intervention.

      Specific Aim #2: Pre-pilot the adapted P-ESDM training and intervention and refine
      methodological details of the experimental protocol. This will provide information on the
      structure, content, and feasibility of the adapted P-ESDM intervention and training approach.

      Specific Aim #3: Pilot of the adapted P-ESDM with preschool aged children with ASD exploring
      the impact on: a) child social communication abilities and overall developmental outcome, and
      b) implementation outcomes.
    

Intervention name(s): Early Start Denver Model
Intervention type(s): Behavioral
Intervention description(s): The Early Start Denver Model is an evidence based, behavioral intervention for young children who have an autism spectrum disorder. It is a behavioral treatment informed by the principles of applied behavior analysis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment