Autism Spectrum DisorderNCT03575429
Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
A study testing Engagement Intervention and Engagement + Coaching Intervention in people with Autism Spectrum Disorder, run by Florida State University at 3 sites in United States.
Trial summary
The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Engagement Intervention and Engagement + Coaching Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Positive screen for autism by community provider in a primary care setting
- Child is between 12 and 24 months old
- Parent completes the Smart Early Screening for Autism and Communication Disorders (ESAC)
- Parent participates in the home observation to complete the Systematic Observation of Red Flags (SORF) of ASD
- Positive autism screen on the SORF
- Lives in the designated study region in Florida and Massachusetts
Who cannot join
- Parent/caregiver declines to participate in the study
- Child is already receiving early intervention services
- Child does not screen positive for autism on the ESAC and/or SORF
- Child is over 24 months old
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Medical Center Corporation
Boston, Massachusetts, 02118
University of Miami
Coral Gables, Florida, 33146
Florida State University Autism Institute
Tallahassee, Florida, 32309
About this study
The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings. The first is to engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem-solving education (MI+PSE). The second is to coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI on parent and child outcomes in 3 sites in Florida and Massachusetts using a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design. In Phase 2, investigators will construct an adaptive intervention to optimize the effects and study the feasibility of implementation in new sites in California. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US.
Read the detailed description
Research shows that a stable diagnosis of autism spectrum disorder (ASD) can be made by trained professionals at 18-24 months and yet the median age of diagnosis in the US is 4-5 years of age. Lower income, minority, and rural families receive a diagnosis up to 1.5 years later and more likely miss the window of opportunity for early intervention (EI). One of the greatest challenges researchers face, in spite of scientific advances and investments, is how to bridge the healthcare science-to-service gap and address health disparities in access to evidence-based EI for children with ASD. Doing this would be the best solution to improve lifelong outcomes, reduce costs to society, and change the landscape of autism.
The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings: 1) engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem solving education (MI+PSE); and 2) coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. Building on existing infrastructure, the Network will infuse mobile technology using the Autism Navigator® collection of web-based courses and tools.
Families will be recruited by screening in community-based primary care and EI systems in 3 diverse regions in 2 states: Florida and Massachusetts. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI in a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design on family engagement in EI, parent use of intervention strategies in everyday activities, and child outcomes of social communication, active engagement, autism symptoms, developmental level, and adaptive behavior. In Phase 2, investigators will construct an adaptive intervention to optimize the effects of MI+PSE with ESI based on the SMART and study the feasibility of implementation in two new service systems in California: Kaiser Permanente Healthcare System and the National Black Church Initiative.
The ACTION Network brings a unique interdisciplinary team with expertise spanning early detection, maternal mental health, clinical trials, health disparities, implementation science, and policy. Using dynamic technology platform the Network has ambitious dissemination aims of informing a community of change agents committed to impact at the population level. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US. Findings will advance science by providing researchers with a method for rapidly deploying evidence-based practices, enabling research at younger ages-accelerating genetic, neuroscience, and intervention research-and lead to transformative changes in workforce development and healthcare delivery.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Engagement Intervention, Engagement + Coaching Intervention
- Keywords
- Pediatrics, Social Communication, Family Navigators
- Medical subject headings
- Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement InterventionBehavioural
Family navigators will use MI to engage families to decrease resistance and build motivation and commitment to challenging behavior changes by eliciting and reflecting broader goals and values, linking those values to specific behavior change, and negotiating a "menu" of options for change based on individual preferences. PSE will be used by the Family Navigators to guide families in selecting an objective, measurable problem, then proceed through a series of steps that involve goal setting, brainstorming and evaluating solutions, choosing a solution, and action planning.
Engagement + Coaching InterventionBehavioural
ESI program planning entails identifying goals and objectives for the child and teaching strategies and supports for parents. Each session includes the following components: 1) setting the stage to develop that visit's agenda and gather updates; 2) intervention implementation that must include the following steps to coach the parent: a) review the objective, b) use modeling, guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to the parent, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and 3) summarize plans for parent implementation between sessions. Families are invited to Autism Navigator How-To Guide for Families, a self-guided web-based course, with an online weekly group meeting.
| Study group | Role | What they receive |
|---|---|---|
| Engagement Intervention | Active comparator | Family navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an intervention that integrates motivational interviewing (MI) and problem-solving education (PSE). The family navigator will meet with parents for up to 6 individual MI+PSE sessions for each 3-month stage of intervention. Receives: Behavioral: Engagement Intervention |
| Engagement + Coaching Intervention | Active comparator | Family navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an intervention that integrates MI+PSE. Family navigators will also coach families to embed intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. The family navigator will meet with parents for 12 weekly home visits for each 3-month stage of intervention. Receives: Behavioral: Engagement + Coaching Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent contingent responsiveness change over time
Parent contingent responsiveness will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS). The MAETS is a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonverbal models; and appropriate expectations and demands. Each component is scored on a 4-point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, and 3 = Mastery. Total scores range from 0 to 32 and higher scores indicate that the level of parent support is better.
Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention at each time point.
Measured: Baseline, 3, 6, 9, and 12 months after the start of intervention
Observation of DSM-5 features of autism spectrum disorder change over time
Features of autism spectrum disorder (ASD) will be periodically measured using the Systematic Observation of Red Flags (SORF) of ASD. The SORF is measured from a home observation of everyday activities. The SORF includes 11 red flags in social communication and social interaction and 11 red flags in restricted and repetitive behaviors using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic features rated on a 3 point scale. The total number of red flags ranges from 0 to 22 and higher scores indicate more red flags of ASD. The total composite score ranges from 0 to 66 and higher scores indicate more diagnostic features of ASD.
Measured: Baseline, 3, 6, 9, and 12 months after the start of intervention
Child social communication change over time
Change in social communication skills will be periodically measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later rated for social communication skills and converted into scores. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze and communication and gestures; and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all 3 composites ranges from 0 to 171. Higher scores on the composites and total indicate better social communication skills.
Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.
Measured: Baseline, 3, 6, 9, and 12 months after the start of intervention
Secondary outcomes (3)
Autism Diagnostic Observation Schedule (ADOS)
Autism symptoms will be measured with the Autism Diagnostic Observation Schedule (ADOS), Second Edition, the gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. Scores range from 1 to 10 and higher scores indicate more autism symptoms. A total of score of 1 to 3 indicates no signs of ASD, a score of 4 or 5 suggests that the child may have ASD, while a score of 6 to 10 is indicative of ASD.
Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.
Measured: 12 months after the start of intervention
Mullen Scales of Early Learning (MSEL)
This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level: Fine Motor; Visual Reception; Expressive Language; and Receptive Language. The average of the four cognitive scales forms an Early Learning Composite. The 4 cognitive scales are measured with T scores that range from 10 to 90 based on a mean T score of 50. A higher T score indicates a better developmental level for the child's age. The Early Learning Composite is measured with Standard scores that range from 40 to 160 based on a mean standard score of 100. A higher standard score indicates a better developmental level for the child's age.
Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.
Measured: 12 months after the start of intervention
Vineland Adaptive Behavior Scales (VABS-3)
Adaptive Behavior will be measured with the Vineland Adaptive Behavior Scales, 3rd edition (VABS-3). The VABS-3 provides a standard score in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. The domain scores are averaged to form an Adaptive Behavior Composite score. The domain and composite standard scores range from 40 to 160 based on a mean standard score of 100. A higher domain and composite standard score indicates a better adaptive behavior for the child's age.
Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.
Measured: 12 months after the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Aug 2019
- Primary completion31 Jan 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Florida State 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study uses a 2-stage sequential multiple assignment randomized trial (SMART) design to optimize a menu of interventions by comparing the order and dose that best meet the needs of families. In stage 1, families will be randomly assigned to one of two study arms for 3 months. Stage 2 interventions will be for another 3 months and will be adapted based on the primary tailoring variable. Early responders will continue the same intervention and slow responders will be re-randomized to an adapted intervention for the next 3 months. The adaptations in stage 2 for slow responders include continuing the treatment arm, adding the other treatment arm, or increasing the dose of the treatment arm. Due to extenuating circumstances associated with COVID-19 from 2020-22, unplanned changes were necessary for slower recruitment than anticipated. Recruitment for the 2-stage SMART ended to allow completion of intervention and outcome measures. Recruitment continued for just stage 1 intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, University of Miami, University of Massachusetts, Boston, Kaiser Permanente, Children's Hospital of Philadelphia, Boston University
- Responsible party
- Principal investigator, Amy M. Wetherby, Florida State University
- Investigators
- Amy Wetherby, PhD, Principal investigator, Florida State University Autism Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575429
- Sponsor's protocol ID
- R01HD093055
- Status last verified
- May 2024
- First submitted
- 15 Jun 2018
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network
- ClinicalTrials.gov ID
- NCT03575429
- Acronym / sponsor ID
- R01HD093055
- Conditions
- Autism Spectrum Disorder
- Keywords
- Pediatrics, Social Communication, Family Navigators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Boston Medical Center, University of Miami, University of Massachusetts, Boston, Kaiser Permanente, Children's Hospital of Philadelphia, Boston University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings. The first is to engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem-solving education (MI+PSE). The second is to coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI on parent and child outcomes in 3 sites in Florida and Massachusetts using a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design. In Phase 2, investigators will construct an adaptive intervention to optimize the effects and study the feasibility of implementation in new sites in California. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US.
Detailed description
Research shows that a stable diagnosis of autism spectrum disorder (ASD) can be made by trained professionals at 18-24 months and yet the median age of diagnosis in the US is 4-5 years of age. Lower income, minority, and rural families receive a diagnosis up to 1.5 years later and more likely miss the window of opportunity for early intervention (EI). One of the greatest challenges researchers face, in spite of scientific advances and investments, is how to bridge the healthcare science-to-service gap and address health disparities in access to evidence-based EI for children with ASD. Doing this would be the best solution to improve lifelong outcomes, reduce costs to society, and change the landscape of autism.
The Autism Adaptive Community-based Treatment to Improve Outcomes Using Navigators (ACTION) Network-a new interdisciplinary network of 6 institutions-will blend clinical effectiveness and implementation research designs to study individual and combined effects of 2 evidence-based interventions in real world settings: 1) engage families to access resources and support when they first learn their child has signs of ASD using an evidence-based intervention that integrates motivational interviewing and problem solving education (MI+PSE); and 2) coach families to embed evidence-based intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. Building on existing infrastructure, the Network will infuse mobile technology using the Autism Navigator® collection of web-based courses and tools.
Families will be recruited by screening in community-based primary care and EI systems in 3 diverse regions in 2 states: Florida and Massachusetts. In Phase 1, investigators will compare the effectiveness of adaptive interventions that use MI+PSE with and without ESI in a 2-stage Sequential Multiple Assignment Randomized Trial (SMART) design on family engagement in EI, parent use of intervention strategies in everyday activities, and child outcomes of social communication, active engagement, autism symptoms, developmental level, and adaptive behavior. In Phase 2, investigators will construct an adaptive intervention to optimize the effects of MI+PSE with ESI based on the SMART and study the feasibility of implementation in two new service systems in California: Kaiser Permanente Healthcare System and the National Black Church Initiative.
The ACTION Network brings a unique interdisciplinary team with expertise spanning early detection, maternal mental health, clinical trials, health disparities, implementation science, and policy. Using dynamic technology platform the Network has ambitious dissemination aims of informing a community of change agents committed to impact at the population level. This research network can build the capacity of community-based systems to provide earlier and widespread access to cost-efficient, community-viable treatment and be ready for immediate and rapid implementation across the US. Findings will advance science by providing researchers with a method for rapidly deploying evidence-based practices, enabling research at younger ages-accelerating genetic, neuroscience, and intervention research-and lead to transformative changes in workforce development and healthcare delivery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a 2-stage sequential multiple assignment randomized trial (SMART) design to optimize a menu of interventions by comparing the order and dose that best meet the needs of families. In stage 1, families will be randomly assigned to one of two study arms for 3 months. Stage 2 interventions will be for another 3 months and will be adapted based on the primary tailoring variable. Early responders will continue the same intervention and slow responders will be re-randomized to an adapted intervention for the next 3 months. The adaptations in stage 2 for slow responders include continuing the treatment arm, adding the other treatment arm, or increasing the dose of the treatment arm. Due to extenuating circumstances associated with COVID-19 from 2020-22, unplanned changes were necessary for slower recruitment than anticipated. Recruitment for the 2-stage SMART ended to allow completion of intervention and outcome measures. Recruitment continued for just stage 1 intervention.
| Arm | Type | Receives |
|---|---|---|
| Engagement Intervention | Active comparator | Behavioral: Engagement InterventionFamily navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an intervention that integrates motivational interviewing (MI) and problem-solving education (PSE). The family navigator will meet with parents for up to 6 individual MI+PSE sessions for each 3-month stage of intervention. |
| Engagement + Coaching Intervention | Active comparator | Behavioral: Engagement + Coaching InterventionFamily navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an intervention that integrates MI+PSE. Family navigators will also coach families to embed intervention strategies for toddlers with ASD in everyday activities using the Early Social Interaction (ESI) model. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. The family navigator will meet with parents for 12 weekly home visits for each 3-month stage of intervention. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Positive screen for autism by community provider in a primary care setting
- Child is between 12 and 24 months old
- Parent completes the Smart Early Screening for Autism and Communication Disorders (ESAC)
- Parent participates in the home observation to complete the Systematic Observation of Red Flags (SORF) of ASD
- Positive autism screen on the SORF
Key exclusion criteria (4 listed)
- Parent/caregiver declines to participate in the study
- Child is already receiving early intervention services
- Child does not screen positive for autism on the ESAC and/or SORF
- Child is over 24 months old
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 |
|---|---|---|
| Engagement InterventionFamily navigators will use MI to engage families to decrease resistance and build motivation and commitment to challenging behavior changes by eliciting and reflecting broader goals and values, linking those values to specific behavior change, and negotiating a "menu" of options for change based on individual preferences. PSE will be used by the Family Navigators to guide families in selecting an objective, measurable problem, then proceed through a series of steps that involve goal setting, brainstorming and evaluating solutions, choosing a solution, and action planning. | Behavioural | Engagement Intervention |
| Engagement + Coaching InterventionESI program planning entails identifying goals and objectives for the child and teaching strategies and supports for parents. Each session includes the following components: 1) setting the stage to develop that visit's agenda and gather updates; 2) intervention implementation that must include the following steps to coach the parent: a) review the objective, b) use modeling, guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to the parent, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and 3) summarize plans for parent implementation between sessions. Families are invited to Autism Navigator How-To Guide for Families, a self-guided web-based course, with an online weekly group meeting. | Behavioural | Engagement + Coaching Intervention |
Primary outcome
Parent contingent responsiveness change over time
Time frame: Baseline, 3, 6, 9, and 12 months after the start of intervention
Parent contingent responsiveness will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS). The MAETS is a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonverbal models; and appropriate expectations and demands. Each component is scored on a 4-point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, and 3 = Mastery. Total scores range from 0 to 32 and higher scores indicate that the level of parent support is better. Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention at each time point.
Observation of DSM-5 features of autism spectrum disorder change over time
Time frame: Baseline, 3, 6, 9, and 12 months after the start of intervention
Features of autism spectrum disorder (ASD) will be periodically measured using the Systematic Observation of Red Flags (SORF) of ASD. The SORF is measured from a home observation of everyday activities. The SORF includes 11 red flags in social communication and social interaction and 11 red flags in restricted and repetitive behaviors using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic features rated on a 3 point scale. The total number of red flags ranges from 0 to 22 and higher scores indicate more red flags of ASD. The total composite score ranges from 0 to 66 and higher scores indicate more diagnostic features of ASD.
Child social communication change over time
Time frame: Baseline, 3, 6, 9, and 12 months after the start of intervention
Change in social communication skills will be periodically measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later rated for social communication skills and converted into scores. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze and communication and gestures; and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all 3 composites ranges from 0 to 171. Higher scores on the composites and total indicate better social communication skills. Families assigned to the Engagement Intervention will be compared with families assigned to Engagement + Coaching Intervention.
3 secondary outcomes
Autism Diagnostic Observation Schedule (ADOS)
Time frame: 12 months after the start of intervention
Mullen Scales of Early Learning (MSEL)
Time frame: 12 months after the start of intervention
Vineland Adaptive Behavior Scales (VABS-3)
Time frame: 12 months after the start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Amy Wetherby, PhD principal investigator
Florida State University Autism Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engagement Intervention and Engagement + Coaching Intervention in people with Autism Spectrum Disorder, run by Florida State University at 3 sites in United States.
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 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parent contingent responsiveness change over time (time frame: Baseline, 3, 6, 9, and 12 months after the start of intervention). The study lists 3 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 16 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.