Tailoring Treatment Targets for Early Autism Intervention in Africa

Autism Spectrum Disorder Clinical Trial

Official title:

Tailoring Treatment Targets for Early Autism Intervention in Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068688
• Other study ID #: Pro00103045
• Secondary ID: 1R21MH120696
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 26, 2021

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 72 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	West Cape

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH), University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postural Sway Measured by the SenseToKnow App	SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).	Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Other	Gaze Patterns Measured by the SenseToKnow App	SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).	Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Other	Social Referencing Measured by the SenseToKnow App	SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).	Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Other	Affective Response Measured by the SenseToKnow App	SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).	Baseline and fBaseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Primary	Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)	Child engagement states measured by the Joint Engagement Rating Inventory (JERI) ; in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)	Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)	Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI)	Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI)	Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Scaffolding Measured by the Joint Engagement Rating Inventory (JERI)	Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI)	Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI)	Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language.	Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Primary	Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS)	Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for initiation of joint attention (IJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention.	Baseline
Primary	Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS)	Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for response to joint attention (RJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. RJA score ranges from 0 to 20 where a higher value indicates greater response to joint attention.	Baseline
Primary	Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)	The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) *100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age.	Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Primary	Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)	The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) *100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age.	Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Primary	Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)	The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Socialization subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior.	Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Primary	Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)	The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Communication subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior.	Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Secondary	Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM)	A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1 - 5 with higher scores indicating greater acceptability.	Follow-up (within 2 weeks of ending sessions)
Secondary	Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM)	A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater appropriateness.	Follow-up (within 2 weeks of ending sessions)
Secondary	Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM)	A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater feasibility.	Follow-up (within 2 weeks of ending sessions)
Secondary	Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System	ESDM Fidelity Rating System uses a 13 item rating scale that includes ratings of performance on core intervention strategies from 1 to 5 (1 represents a lack of an effective display of the practices specified, and 5 represents the best possible example of this teaching behavior). Fidelity of implementation of Naturalistic Developmental Behavioral Intervention (NDBI) strategies will be manually coded by certified ESDM therapists. Mean fidelity scores (with SD) will be calculated across study participants in order to assess change in NDBI strategies. ESDM Fidelity Rating System scores range from 0 to 100 with a higher score reflecting interactions closer to ESDM principles.	Baseline and Follow-up (up to 4 months)