Tailoring Treatment Targets for Early Autism Intervention in Africa

NCT ID: NCT04068688

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-08-26

Brief Summary

Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development. While efforts to use NDBIs are increasing worldwide, important gaps in our knowledge remain on whether the behaviors targeted by NDBIs are cross-culturally valid. This study in South Africa, a multi-cultural setting, will provide critical information on NDBI treatment targets and a novel digital outcome measure of treatment response.

COVID-19 adaptations: We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach to gather implementation and preliminary effectiveness data on the telehealth intervention.

Detailed Description

COVID-19 has significantly impacted autism spectrum disorder (ASD) clinical research and disrupted access to intervention services for children and families globally. In this ongoing study in Cape Town South Africa, a caregiver coaching Naturalistic Developmental Behavioral Intervention (NDBI) for young children with ASD has been adapted for implementation by non-specialists and implementation and clinical outcomes are being evaluated. For ongoing clinical trials, the University of Cape Town Institutional Review Board (IRB) has encouraged researchers to switch to a virtual platform, where possible. Telehealth caregiver coaching is cost-effective, increases access to rural and underserved populations, and improves understanding of family home and caregiving routines. We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach and a longitudinal pre-post design to gather implementation and preliminary effectiveness data on the telehealth intervention.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Caregiver-Child Dyads with ASD (Autism Spectrum Disorder)

Participants in this arm will be caregivers of and children with ASD.

Group Type: EXPERIMENTAL

Early Start Denver Model (ESDM)

Intervention Type: BEHAVIORAL

Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid.

Children with typical development

Participants in this arm will be children with typical development.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Children with developmental delay

Participants in this arm will be children with developmental delay.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) Telehealth Adaptation

Participants in this arm will be caregivers of and children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions).

Group Type: EXPERIMENTAL

Telehealth coaching

Intervention Type: BEHAVIORAL

The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist.

Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors

The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Early Start Denver Model (ESDM) Supervisors

The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early Start Denver Model (ESDM)

Twelve one hour sessions, skill is introduced by "Help is in your hands" Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. "Help is in your hands" Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid.

Intervention Type: BEHAVIORAL

Telehealth coaching

The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. For ASD, DD, TD groups

• Subject family speaks isiXhosa, Afrikaans, or English
• Child's ethnicity/race is African or Coloured (A South African term for individuals with mixed racial heritage)
• Child lives within an area served by the recruitment sites

2. For the ASD group only:

• Child meets criteria for an ASD diagnosis based upon DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria and informed by the ADOS-2 (Autism Diagnostic Observation Schedule) administered by research reliable raters
• Caregiver is at least 18 years old

3. For the developmental delay (DD) group only:

• Child screens positive on the Ten Questions and negative for ASD on the ABC
• Child has been diagnosed with developmental delay by a developmental pediatrician

4. For the typically developing (TD) group only:

-Child screens negative on the Ten Questions and negative for ASD on the ABC

5. For the Early Childhood Development (ECD) Practitioners and Early Childhood Development Practitioner School Supervisors group:

• Employed by participating recruitment partners (Western Cape Education Department Schools)
• Involved in delivery of the caregiver coaching sessions, either in person or remotely

6. For the Early Start Denver Model (ESDM) supervisors group:

• Trained ESDM therapist
• Supervise weekly coaching sessions in the schools, and/or
• Supervise remote intervention delivery sessions

Exclusion Criteria

1. For all groups (ASD, DD, TD)

• Significant sensory or motor impairment
• Major physical abnormalities
• History of serious head injury and/or neurological disease

2. For the ASD group:

• Presence of a neurological disorder of known etiology (for e.g., Downs Syndrome)
• Caregiver-child dyad unable to attend assessments and 12 coaching sessions

3. For the developmental delay (DD) group

-Autism diagnosis based on DSM 5 criteria

4. For typically developing (TD group:

• Autism diagnosis based on DSM 5 criteria

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cape Town

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Franz, MB, CHB

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

University of Cape Town

Cape Town, West Cape, South Africa

Countries

South Africa

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21MH120696

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00103045

Identifier Type: -

Identifier Source: org_study_id