Autism Spectrum DisorderNCT05425277
Assessing the Effectiveness of Reciprocal Imitation Teaching in Part C Early Intervention Settings (Sprout Study)
A study testing Reciprocal Intervention Teaching (RIT) and Daily Routines in people with Autism Spectrum Disorder, run by University of Washington at 1 site in United States.
Trial summary
Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. Read more about this study
- Who is it for?
- Ages 18 months to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Reciprocal Intervention Teaching (RIT) and Daily Routines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 5 Jan 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 18 months to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- EI Providers:
- Speak and read English
- Work at a participating Part C practice or agency
- Have an active caseload that includes at least two children with ASD or suspected ASD
- Are willing to invite families to participate in this study
- Caregivers and Toddlers (recruited from EI provider caseloads):
Show all 12Show fewer
- Caregivers speak and read English or Spanish
- Caregivers are at least 18 years of age
- Caregivers are willing and able to participate in intervention sessions and research tele-visits that are video-recorded by research staff
- Child receives services from one of the participating agencies and attends regular sessions with the enrolled provider
- Child is between 18 and 30 months of age at study entry
- Child has a diagnosis of ASD or displays social communication impairments consistent with ASD
Who cannot join
- Child has no severe visual, auditory, or physical impairments and no serious medical, genetic, or neurological conditions that would impede their ability to engage in RIT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effectiveness of a Low-Cost, Evidence-Based Naturalistic Developmental Behavioral Intervention (NDBI) in IDEA Part C Early Intervention Settings
Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of a brief, inexpensive training on EI providers' ability to deliver an evidence-based, caregiver-mediated intervention that can improve providers' comfort and effectiveness in working with families of children with social communication concerns, as well as improving child and family outcomes.
Read the detailed description
Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The long-term goal of this study is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of training EI providers to deliver an evidence-based, inexpensive, caregiver-mediated intervention that can improve child and family outcomes as well as mitigate the substantial economic costs associated with ASD. This research will take place within an existing community-based infrastructure: the Part C Early Intervention (EI) service delivery system. Part C is publicly funded, available throughout the country, and serves children under age 3 who have developmental delays or disabilities, and their families. Currently, the effectiveness of EI services is limited by high practice variation and infrequent use of evidence-based interventions. The study objective is to improve services and outcomes for children with early signs of ASD and their families. Toward that end, the investigators are conducting a randomized controlled trial (RCT) examining the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT), as compared to an active control condition. RIT is a naturalistic developmental behavioral intervention (NDBI) that is ideally suited for EI settings because it is low intensity, play-based, easy to learn and implement, and can be taught to families for their independent use, thus increasing intervention dosage. The investigators will conduct this study within the context of an effectiveness-implementation hybrid type 1 design to gather evidence that will be essential for implementing RIT in other communities if it is found to improve child and caregiver outcomes.
EI providers will be randomly assigned to either the RIT training (n=30) or an active control condition (n=30). Providers in both conditions will complete surveys about their caseloads and intervention practices at 5 time points, once before their training workshops and four times after the workshop (1, 3, 6, and 12 months post-training). Providers assigned to the RIT training condition will receive an 8-hour virtual workshop on the rationale for, and implementation of, RIT with families, with an emphasis on caregiver coaching. Providers assigned to the active control condition ('Daily Routines') will receive a 3-hour virtual workshop on methods for helping caregivers increase their children's participation and social engagement during everyday home routines. Providers in this condition will be able to receive RIT training at the end of the study.
Providers in both conditions will also invite 2 families from their caseload to participate in this study. Caregiver recruitment and data collection will begin immediately after the training workshops are conducted with providers. Enrolled families must speak and read English or Spanish and have a child between 18 and 30 months for whom ASD is either suspected or confirmed. Caregiver participation involves having one EI session videotaped, completing survey measures at 3 time points, and conducting a play-based assessment in their homes (with coaching) at the same 3 time points: baseline, 3 months later, and 6 months post-baseline. The play-based assessment will measure children's motor imitation, social communication, caregiver fidelity to RIT, and caregiver use of child-centered interaction strategies. At the same 3 timepoints, caregivers will complete measures about their parenting stress and parenting self-efficacy, their child's social communication and language, and any additional services the child is receiving. The child's adaptive behavior will be measured via caregiver-interview at baseline and 6-months. Caregivers will also report on the 'top concerns' they have about their child at baseline, and will rate the severity of these concerns monthly thereafter. Family-level "RIT dosage" will also be measured via a weekly Dosage Log sent to caregivers via text message. Caregiver-reported satisfaction with treatment and the study, as well as caregiver-reported child ASD symptomatology will be collected at their final visit (6-months after enrollment).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Reciprocal Intervention Teaching (RIT), Daily Routines
- Keywords
- ASD, 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.
Reciprocal Intervention Teaching (RIT)Behavioural
RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and initiating joint attention during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal social-communicative skills. RIT is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by caregivers and siblings.
Daily RoutinesBehavioural
The Routines webinar was adapted from a web-based tutorial developed by PI Stone and colleagues (Ibanez et al., 2018). The webinar covers topics such as why everyday routines are important, especially for children with ASD, specific steps for increasing children's participation in routines, and how to use strategies such as visual supports to clarify expectations, and provides numerous video examples of caregivers using different strategies. Providers are also given access to a video library of caregivers using the Daily Routines strategies with their children, as well as a workbook to use with families during treatment.
| Study group | Role | What they receive |
|---|---|---|
| RIT Training Group | Experimental | Providers in the RIT group (n=30) will receive an 8-hour virtual workshop (2 half-days) on RIT implementation and caregiver coaching. Each provider will invite 2 families in their caseload to participate in the study. Providers will coach families in the use of RIT. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity. Receives: Behavioral: Reciprocal Intervention Teaching (RIT) |
| Daily Routines | Active comparator | Providers in the Routines Control group (n=30) will receive a 3-hour virtual workshop focused on helping providers coach caregivers on how to increase children's participation and social engagement during everyday home routines (i.e., snack time, bedtime, bath time, and family playtime). Each provider will invite 2 families in their caseload to participate in the study. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity to ensure contamination has not occurred and the control condition providers are not utilizing RIT strategies. Receives: Behavioral: Daily Routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Social Communication - In Vivo
Change in in-vivo observation of child social communication will be assessed using the scored social communication items on the TELE-ASD-PEDS (TAP; Corona et al., 2021). There are 5 social communication items that can be scored 1-3 (range 5-15, with lower scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Child Social Communication - Parent Report
Change in parent reported child social communication will be assessed using three subscales from the the Parent Interview for Autism-Clinical Version (PIA-CV; Stone et al., 2003).The subscales that will be examined are: Social Relating (17 questions), Language Understanding (7 questions), and Nonverbal Communication (13 questions). These items can be scored 1-5 (range 37-185, with higher scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Child Social Communication - Behaviorally Coded
Change in behaviorally coded child social communication will be assessed using the observationally coded Weighted Frequency of Intentional Communication during a parent-child free play task (Yoder et al., 2009).
Measured: Change from baseline to 6-month follow-up
Child Motor Imitation - In Vivo
Change in behaviorally observed motor imitation will be assessed using an adapted version of the Motor Imitation Scale (MIS; Stone et al., 1997). Five items with three trials each will be presented to the child. If a child receives a maximum score, the item is discontinued. Each trial can be scored 0-2 (range 0-10, with higher scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Child Motor Imitation - Parent Report
Change in parent reported motor imitation will be assessed using the Parent Interview for Autism-Clinical Version (PIA-CV; Stone et al., 2003). The Imitation subscale (4 items) will be examined. These items can be scored 1-5 (range 4-20, with higher scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Provider Coaching of Caregivers in RIT Strategies
Change in providers' use of caregiver coaching strategies will be assessed via provider self-report survey.
Measured: Change from baseline to 12-month follow-up
Caregiver Use of RIT Strategies
Change in caregiver use of RIT strategies will be assessed via a caregiver-child activity in which caregivers are instructed to demonstrate the skills they learned from their (enrolled) EI provider; scoring will employ the RIT Fidelity Checklist (range 6-30, with higher scores indicating higher fidelity to RIT).
Measured: Change from baseline to 6-month follow-up
Secondary outcomes (5)
Child Adaptive Behavior
Change in child adaptive behavior will be assessed using the Vineland Adaptive Behavior Scale - Third Edition (Vineland-3; Sparrow et al., 2016). The Vineland-3 provides norm-referenced scaled scores for 11 skill areas (M = 10; SD = 3) as well as standard scores (M =100, SD = 15) for three adaptive domains, with higher scores indicating better outcome.
Measured: Change from baseline to 6-month follow-up
Child Language
Change in child language will be assessed using the MacArthur Bates Communicative Development Inventory (MCDI; Fenson et al., 2007). The MB-CDI is scored from 0 to 100 percentile, with a higher percentile indicating better outcome.
Measured: Change from baseline to 6-month follow-up
Parenting Self-Efficacy
Change in parenting self-efficacy will be measured using the Parenting Efficacy Scale (PES; Teti \& Gelfand, 1991). The PES contains 10 items scored 1-4 (range 10-40, with higher scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Parenting Stress
Change in parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF; Abidin, 1990). The PSI-SF contains 36 items scored 0-4 and total score is presented as a percentile (range 0-100 with lower scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Caregiver Top Concerns
Change in severity ratings of each individual caregiver's top concerns about their child will be measured using an adapted version of the Caregiver Top Problems assessment (TPA; Weisz et al., 2013). The three items are rated from 0-4 (range 0-12, with lower scores indicating better outcome).
Measured: Change from baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 May 2021
- Primary completion5 Jan 2024
- Study completion5 Jan 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 University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Wendy Stone, University of Washington
- Investigators
- Wendy L Stone, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425277
- Sponsor's protocol ID
- STUDY00007803
- Other IDs
- W81XWH1910293
- Status last verified
- Feb 2024
- First submitted
- 12 Jun 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a Low-Cost, Evidence-Based Naturalistic Developmental Behavioral Intervention (NDBI) in IDEA Part C Early Intervention Settings
- ClinicalTrials.gov ID
- NCT05425277
- Acronym / sponsor ID
- STUDY00007803
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 15 May 2021 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 21 Jun 2022 (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.
Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of a brief, inexpensive training on EI providers' ability to deliver an evidence-based, caregiver-mediated intervention that can improve providers' comfort and effectiveness in working with families of children with social communication concerns, as well as improving child and family outcomes.
Detailed description
Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The long-term goal of this study is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of training EI providers to deliver an evidence-based, inexpensive, caregiver-mediated intervention that can improve child and family outcomes as well as mitigate the substantial economic costs associated with ASD. This research will take place within an existing community-based infrastructure: the Part C Early Intervention (EI) service delivery system. Part C is publicly funded, available throughout the country, and serves children under age 3 who have developmental delays or disabilities, and their families. Currently, the effectiveness of EI services is limited by high practice variation and infrequent use of evidence-based interventions. The study objective is to improve services and outcomes for children with early signs of ASD and their families. Toward that end, the investigators are conducting a randomized controlled trial (RCT) examining the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT), as compared to an active control condition. RIT is a naturalistic developmental behavioral intervention (NDBI) that is ideally suited for EI settings because it is low intensity, play-based, easy to learn and implement, and can be taught to families for their independent use, thus increasing intervention dosage. The investigators will conduct this study within the context of an effectiveness-implementation hybrid type 1 design to gather evidence that will be essential for implementing RIT in other communities if it is found to improve child and caregiver outcomes.
EI providers will be randomly assigned to either the RIT training (n=30) or an active control condition (n=30). Providers in both conditions will complete surveys about their caseloads and intervention practices at 5 time points, once before their training workshops and four times after the workshop (1, 3, 6, and 12 months post-training). Providers assigned to the RIT training condition will receive an 8-hour virtual workshop on the rationale for, and implementation of, RIT with families, with an emphasis on caregiver coaching. Providers assigned to the active control condition ('Daily Routines') will receive a 3-hour virtual workshop on methods for helping caregivers increase their children's participation and social engagement during everyday home routines. Providers in this condition will be able to receive RIT training at the end of the study.
Providers in both conditions will also invite 2 families from their caseload to participate in this study. Caregiver recruitment and data collection will begin immediately after the training workshops are conducted with providers. Enrolled families must speak and read English or Spanish and have a child between 18 and 30 months for whom ASD is either suspected or confirmed. Caregiver participation involves having one EI session videotaped, completing survey measures at 3 time points, and conducting a play-based assessment in their homes (with coaching) at the same 3 time points: baseline, 3 months later, and 6 months post-baseline. The play-based assessment will measure children's motor imitation, social communication, caregiver fidelity to RIT, and caregiver use of child-centered interaction strategies. At the same 3 timepoints, caregivers will complete measures about their parenting stress and parenting self-efficacy, their child's social communication and language, and any additional services the child is receiving. The child's adaptive behavior will be measured via caregiver-interview at baseline and 6-months. Caregivers will also report on the 'top concerns' they have about their child at baseline, and will rate the severity of these concerns monthly thereafter. Family-level "RIT dosage" will also be measured via a weekly Dosage Log sent to caregivers via text message. Caregiver-reported satisfaction with treatment and the study, as well as caregiver-reported child ASD symptomatology will be collected at their final visit (6-months after enrollment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIT Training Group | Experimental | Behavioral: Reciprocal Intervention Teaching (RIT)Providers in the RIT group (n=30) will receive an 8-hour virtual workshop (2 half-days) on RIT implementation and caregiver coaching. Each provider will invite 2 families in their caseload to participate in the study. Providers will coach families in the use of RIT. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity. |
| Daily Routines | Active comparator | Behavioral: Daily RoutinesProviders in the Routines Control group (n=30) will receive a 3-hour virtual workshop focused on helping providers coach caregivers on how to increase children's participation and social engagement during everyday home routines (i.e., snack time, bedtime, bath time, and family playtime). Each provider will invite 2 families in their caseload to participate in the study. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity to ensure contamination has not occurred and the control condition providers are not utilizing RIT strategies. |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Speak and read English
- Work at a participating Part C practice or agency
- Have an active caseload that includes at least two children with ASD or suspected ASD
- Are willing to invite families to participate in this study
- Caregivers speak and read English or Spanish
Key exclusion criteria (1 listed)
- Child has no severe visual, auditory, or physical impairments and no serious medical, genetic, or neurological conditions that would impede their ability to engage in RIT.
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 |
|---|---|---|
| Reciprocal Intervention Teaching (RIT)RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and initiating joint attention during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal social-communicative skills. RIT is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by caregivers and siblings. | Behavioural | RIT Training Group |
| Daily RoutinesThe Routines webinar was adapted from a web-based tutorial developed by PI Stone and colleagues (Ibanez et al., 2018). The webinar covers topics such as why everyday routines are important, especially for children with ASD, specific steps for increasing children's participation in routines, and how to use strategies such as visual supports to clarify expectations, and provides numerous video examples of caregivers using different strategies. Providers are also given access to a video library of caregivers using the Daily Routines strategies with their children, as well as a workbook to use with families during treatment. | Behavioural | Daily Routines |
Primary outcome
Child Social Communication - In Vivo
Time frame: Change from baseline to 6-month follow-up
Change in in-vivo observation of child social communication will be assessed using the scored social communication items on the TELE-ASD-PEDS (TAP; Corona et al., 2021). There are 5 social communication items that can be scored 1-3 (range 5-15, with lower scores indicating better outcome).
Child Social Communication - Parent Report
Time frame: Change from baseline to 6-month follow-up
Change in parent reported child social communication will be assessed using three subscales from the the Parent Interview for Autism-Clinical Version (PIA-CV; Stone et al., 2003).The subscales that will be examined are: Social Relating (17 questions), Language Understanding (7 questions), and Nonverbal Communication (13 questions). These items can be scored 1-5 (range 37-185, with higher scores indicating better outcome).
Child Social Communication - Behaviorally Coded
Time frame: Change from baseline to 6-month follow-up
Change in behaviorally coded child social communication will be assessed using the observationally coded Weighted Frequency of Intentional Communication during a parent-child free play task (Yoder et al., 2009).
Child Motor Imitation - In Vivo
Time frame: Change from baseline to 6-month follow-up
Change in behaviorally observed motor imitation will be assessed using an adapted version of the Motor Imitation Scale (MIS; Stone et al., 1997). Five items with three trials each will be presented to the child. If a child receives a maximum score, the item is discontinued. Each trial can be scored 0-2 (range 0-10, with higher scores indicating better outcome).
Child Motor Imitation - Parent Report
Time frame: Change from baseline to 6-month follow-up
Change in parent reported motor imitation will be assessed using the Parent Interview for Autism-Clinical Version (PIA-CV; Stone et al., 2003). The Imitation subscale (4 items) will be examined. These items can be scored 1-5 (range 4-20, with higher scores indicating better outcome).
Provider Coaching of Caregivers in RIT Strategies
Time frame: Change from baseline to 12-month follow-up
Change in providers' use of caregiver coaching strategies will be assessed via provider self-report survey.
Caregiver Use of RIT Strategies
Time frame: Change from baseline to 6-month follow-up
Change in caregiver use of RIT strategies will be assessed via a caregiver-child activity in which caregivers are instructed to demonstrate the skills they learned from their (enrolled) EI provider; scoring will employ the RIT Fidelity Checklist (range 6-30, with higher scores indicating higher fidelity to RIT).
5 secondary outcomes
Child Adaptive Behavior
Time frame: Change from baseline to 6-month follow-up
Child Language
Time frame: Change from baseline to 6-month follow-up
Parenting Self-Efficacy
Time frame: Change from baseline to 6-month follow-up
Parenting Stress
Time frame: Change from baseline to 6-month follow-up
Caregiver Top Concerns
Time frame: Change from baseline to 6-month follow-up
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Wendy L Stone, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocal Intervention Teaching (RIT) and Daily Routines in people with Autism Spectrum Disorder, run by University of Washington at 1 site 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 12 inclusion and 1 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 22 Nov 2024. 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 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?
Child Social Communication - In Vivo (time frame: Change from baseline to 6-month follow-up). The study lists 7 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 22 Nov 2024.