Autism Spectrum DisorderNCT04068688
Tailoring Treatment Targets for Early Autism Intervention in Africa
A study testing Early Start Denver Model (ESDM) and Telehealth coaching in people with Autism Spectrum Disorder, run by Duke University at 1 site in South Africa.
Trial summary
Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development. Read more about this study
- Who is it for?
- Ages 18 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Start Denver Model (ESDM) and Telehealth coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Sep 2019to 26 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- 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
Show all 19Show fewer
- Caregiver is at least 18 years old
- 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
- For the typically developing (TD) group only:
- -Child screens negative on the Ten Questions and negative for ASD on the ABC
- 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
- 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
Who cannot join
- For all groups (ASD, DD, TD)
- Significant sensory or motor impairment
- Major physical abnormalities
- History of serious head injury and/or neurological disease
- For the ASD group:
- Presence of a neurological disorder of known etiology (for e.g., Downs Syndrome)
Show all 11Show fewer
- Caregiver-child dyad unable to attend assessments and 12 coaching sessions
- For the developmental delay (DD) group
- -Autism diagnosis based on DSM 5 criteria
- For typically developing (TD group:
- Autism diagnosis based on DSM 5 criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Early Start Denver Model (ESDM), Telehealth coaching
- Keywords
- NDBI, Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver Model (ESDM)Behavioural
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 coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) | Experimental | Participants in this arm will be caregivers of and children with ASD. Receives: Behavioral: Early Start Denver Model (ESDM) |
| Children with typical development | No intervention | Participants in this arm will be children with typical development. |
| Children with developmental delay | No intervention | Participants in this arm will be children with developmental delay. |
| Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) Telehealth Adaptation | Experimental | Participants in this arm will be caregivers of and children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). Receives: Behavioral: Telehealth coaching |
| Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | No intervention | 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. |
| Early Start Denver Model (ESDM) Supervisors | No intervention | The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
Measured: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Secondary outcomes (4)
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.
Measured: Follow-up (within 2 weeks of ending sessions)
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.
Measured: Follow-up (within 2 weeks of ending sessions)
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.
Measured: Follow-up (within 2 weeks of ending sessions)
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.
Measured: Baseline and Follow-up (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019
- Primary completion26 Aug 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Note the autism group will be the only group to receive intervention. The typically developing and developmental delay group will receive one baseline assessment, and no intervention. COVID-19 necessitated a pivot from in-person to telehealth coaching.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lauren Franz, MB, CHB, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068688
- Sponsor's protocol ID
- Pro00103045
- Other IDs
- 1R21MH120696
- Status last verified
- Nov 2022
- First submitted
- 20 Aug 2019
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual-level descriptive data will be submitted to the NIH/NIMH (National Institute of Mental Health) data repositories on a quarterly. Submission of all other experimental data will occur after the primary objectives of the R21 have been met. Prior to submission, dedicated research staff will review accuracy and conduct additional manual and automated checks for presence of protected health information (PHI) in the submitted data. Submissions will include protocols, questionnaires, study manuals, variables measured, and any other necessary documentation. All submitted data (both descriptive/raw and analyzed data) will be made available for access by members of the research community according to the provisions defined in the NDAR (National Database for Autism Research) and the NIH/NIMH Data Repositories Data Sharing Policy. All research data will be made accessible to other researchers within four months of submission, allowing sufficient time to complete QA/QC procedures.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Treatment Targets for Early Autism Intervention in Africa
- ClinicalTrials.gov ID
- NCT04068688
- Acronym / sponsor ID
- Pro00103045
- Conditions
- Autism Spectrum Disorder
- Keywords
- NDBI, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Note the autism group will be the only group to receive intervention. The typically developing and developmental delay group will receive one baseline assessment, and no intervention. COVID-19 necessitated a pivot from in-person to telehealth coaching.
| Arm | Type | Receives |
|---|---|---|
| Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) | Experimental | Behavioral: Early Start Denver Model (ESDM)Participants in this arm will be caregivers of and children with ASD. |
| Children with typical development | No intervention | –Participants in this arm will be children with typical development. |
| Children with developmental delay | No intervention | –Participants in this arm will be children with developmental delay. |
| Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) Telehealth Adaptation | Experimental | Behavioral: Telehealth coachingParticipants in this arm will be caregivers of and children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions). |
| Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | No intervention | –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. |
| Early Start Denver Model (ESDM) Supervisors | No intervention | –The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- For ASD, DD, TD groups
- For the ASD group only:
- For the developmental delay (DD) group only:
- For the typically developing (TD) group only:
- -Child screens negative on the Ten Questions and negative for ASD on the ABC
Key exclusion criteria (11 listed)
- For all groups (ASD, DD, TD)
- For the ASD group:
- For the developmental delay (DD) group
- -Autism diagnosis based on DSM 5 criteria
- For typically developing (TD group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) |
| Telehealth coachingThe 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. | Behavioural | Caregiver-Child Dyads with ASD (Autism Spectrum Disorder) Telehealth Adaptation |
Primary outcome
Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Scaffolding Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI)
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
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.
Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS)
Time frame: Baseline
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.
Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS)
Time frame: Baseline
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.
Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
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.
4 secondary outcomes
Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM)
Time frame: Follow-up (within 2 weeks of ending sessions)
Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM)
Time frame: Follow-up (within 2 weeks of ending sessions)
Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM)
Time frame: Follow-up (within 2 weeks of ending sessions)
Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System
Time frame: Baseline and Follow-up (up to 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All individual-level descriptive data will be submitted to the NIH/NIMH (National Institute of Mental Health) data repositories on a quarterly. Submission of all other experimental data will occur after the primary objectives of the R21 have been met. Prior to submission, dedicated research staff will review accuracy and conduct additional manual and automated checks for presence of protected health information (PHI) in the submitted data. Submissions will include protocols, questionnaires, study manuals, variables measured, and any other necessary documentation. All submitted data (both descriptive/raw and analyzed data) will be made available for access by members of the research community according to the provisions defined in the NDAR (National Database for Autism Research) and the NIH/NIMH Data Repositories Data Sharing Policy. All research data will be made accessible to other researchers within four months of submission, allowing sufficient time to complete QA/QC procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Franz, MB, CHB principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Start Denver Model (ESDM) and Telehealth coaching in people with Autism Spectrum Disorder, run by Duke University at 1 site in South Africa.
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 19 inclusion and 11 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: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) (time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2022.