Autism Spectrum DisorderNCT07520838
Improving Barriers to Care Access for Children With Autism and Related Needs Via Telehealth for Evaluation, Care Navigating, and Caregiver Coaching
A study testing NDBI in people with Autism Spectrum Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The objectives of the current project are to develop and implement training with community providers to evaluate a supplemental parent coaching intervention delivered via telehealth to improve child communication and behavioral outcomes, parental stress outcomes, and to investigate telehealth models to reach children… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- NDBI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Provider Inclusion Criteria:
- Providers to participate who are in "lead" or supervising roles (e.g., clinical supervisors, lead therapists, level II/level I EIDBI providers),
- Participating providers are encouraged to have a master's degree or higher, be level I, or serve as a level II provider with established experience (e.g.,supporting families who speak another language or be certified by a tribal government) however, this decision is up to the participating organization
Child/Caregiver Inclusion Criteria:
- Child between ages 1 to 5
- Waiting for either ASD diagnosis or intervention,
- At least one caregiver (approved by the parent) willing to participate
- Ability to complete approximately three, 30 min sessions over 12 weeks and to complete pre and post study measures
- Child may not be currently receiving intensive (10 or more hours a week) or early intensive behavioral intervention (EIBI), but may be on a waitlist for these services, and can be enrolled in Early Childhood Special Education services Parts B and C, and auxiliary services such as speech, physical, and occupational therapy.
Child/Caregiver Exclusion Criteria:
- Children will be assessed through an eligibility screener to determine if they have challenging behavior that may be dangerous. Families will be assessed to determine eligibility through a screener, several of the questions will be aimed to identify challenging behavior severity, behaviors including topographies such as eye gouging and other forms of severe self-injury or aggression that cause significant or dangerous tissue damage (e.g., such as breaking the skin, drawing blood, open wounds that could be infected, or leaves a contusion, visits to an emergency room or hospitalization due to challenging behavior) to a child or others may be considered too severe to participate in the study.
- Families will also be asked if a participating caregiver is pregnant, if they indicate yes, they will still be eligible to participate with their child, but certain activities may be skipped if the child engages in challenging behavior, such as aggressive behavior.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jessica Simacek, PhD, 612-624-1450, sima0034@umn.edu
About this study
The objectives of the current project are to develop and implement training with community providers to evaluate a supplemental parent coaching intervention delivered via telehealth to improve child communication and behavioral outcomes, parental stress outcomes, and to investigate telehealth models to reach children in geographically dispersed or highly mobile locations and/or from military connected families.
- Conditions
- Autism Spectrum Disorder
- Being tested
- NDBI
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDBIOther
The NDBI strategies (e.g., behavioral principles such as reinforcement) embedded within family-centered routines will be used to target child communication, social reciprocity, and parental responsivity. Collateral effects of the supplemental treatment package will be observed in terms of parental stress/efficacy and family quality of life as well. NDBI strategies and methodology provide a powerful tool to increase (and maintain via reinforcement) adaptive behaviors by teaching new skills and promoting generalization of these skills across settings and contexts.
| Study group | Role | What they receive |
|---|---|---|
| Naturalistic Developmental Behavioral Intervention (NDBI) | Experimental | NDBIs are embedded with developmental principles and practices with an emphasis placed on naturalistic intervention elements (e.g., targeting skills within a developmentally appropriate sequence). In addition to adhering to recommended early intervention practices involving naturalized, routines-based, and family-centered interventions, NDBIs may be easier for parents to implement and may promote child skill acquisition in a natural manner and therefore promote generalization and maintenance of skills. Receives: Other: NDBI |
| Waitlist | No intervention | Families randomized to this condition have a 12-week waiting period, after which point they rollover to the NDBI intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Observation of Social Communication Change (BOSCC)
15 items, each scored from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning.
Minimum score = 0 Maximum score = 75 Higher score = higher impact on functioning (worse outcome)
Measured: Week 12
Change in Repetitive Behavior Scale for Early Childhood
4 items across 4 subscales; scored from 0 (bx does not occur) to 4 (bx occurs many times per day)
Minimum score = 0 Maximum score = 136 Higher score = more frequent/severe repetitive behaviors (worse outcome)
Measured: Week 12
Change in Autism Impact Measure
41 items
Individual subdomains (frequency and intensity) Minimum score: 41 Maximum score: 205 Higher score = poorer outcomes
Total score:
Minimum score: 82 Maximum score: 410 Higher score = poorer outcomes
Measured: Week 12
Change in Autism Family Experience Questionnaire
48 items, each scored on a 1-5 scale
Minimum score = 48 Maximum score = 240 Higher score = poor outcomes
Measured: Week 12
Change in Measure of NDBI Strategy Implementation-Caregiver Change
21 items on a 1-5 scale
Minimum score: 21 Maximum score: 105 Lower score = poorer strategy implementation
Measured: Week 12
Measure Fidelity
Completed weekly until community provider participants reach 80% fidelity. The form consists of a 15 point questionnaire completed by the trainer, which was created by the study team. The score for each item = NA, 0, 1 or 2. Max fidelity score 24-30 (3 items can be scored as NA meaning not applicable or no opportunity.)
Measured: Week 12
Provider Knowledge Gain
Administered before and after synchronous training session conducted by study intervention team to measure community provider participant's knowledge of the training topics. The measure consists of 8 multiple choice questions and 15 short answer questions. Completion of the questionnaires informs provider baseline knowledge as well as future modifications to the training curriculum.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start25 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
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 MinnesotaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Simacek, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520838
- Sponsor's protocol ID
- ICI-2024-33129
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Barriers to Care Access for Children With Autism and Related Needs Via Telehealth for Evaluation, Care Navigating, and Caregiver Coaching
- ClinicalTrials.gov ID
- NCT07520838
- Acronym / sponsor ID
- ICI-2024-33129
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Apr 2026 (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 objectives of the current project are to develop and implement training with community providers to evaluate a supplemental parent coaching intervention delivered via telehealth to improve child communication and behavioral outcomes, parental stress outcomes, and to investigate telehealth models to reach children in geographically dispersed or highly mobile locations and/or from military connected families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naturalistic Developmental Behavioral Intervention (NDBI) | Experimental | Other: NDBINDBIs are embedded with developmental principles and practices with an emphasis placed on naturalistic intervention elements (e.g., targeting skills within a developmentally appropriate sequence). In addition to adhering to recommended early intervention practices involving naturalized, routines-based, and family-centered interventions, NDBIs may be easier for parents to implement and may promote child skill acquisition in a natural manner and therefore promote generalization and maintenance of skills. |
| Waitlist | No intervention | –Families randomized to this condition have a 12-week waiting period, after which point they rollover to the NDBI intervention. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| NDBIThe NDBI strategies (e.g., behavioral principles such as reinforcement) embedded within family-centered routines will be used to target child communication, social reciprocity, and parental responsivity. Collateral effects of the supplemental treatment package will be observed in terms of parental stress/efficacy and family quality of life as well. NDBI strategies and methodology provide a powerful tool to increase (and maintain via reinforcement) adaptive behaviors by teaching new skills and promoting generalization of these skills across settings and contexts. | Other | Naturalistic Developmental Behavioral Intervention (NDBI) |
Primary outcome
Change in Brief Observation of Social Communication Change (BOSCC)
Time frame: Week 12
15 items, each scored from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning. Minimum score = 0 Maximum score = 75 Higher score = higher impact on functioning (worse outcome)
Change in Repetitive Behavior Scale for Early Childhood
Time frame: Week 12
4 items across 4 subscales; scored from 0 (bx does not occur) to 4 (bx occurs many times per day) Minimum score = 0 Maximum score = 136 Higher score = more frequent/severe repetitive behaviors (worse outcome)
Change in Autism Impact Measure
Time frame: Week 12
41 items Individual subdomains (frequency and intensity) Minimum score: 41 Maximum score: 205 Higher score = poorer outcomes Total score: Minimum score: 82 Maximum score: 410 Higher score = poorer outcomes
Change in Autism Family Experience Questionnaire
Time frame: Week 12
48 items, each scored on a 1-5 scale Minimum score = 48 Maximum score = 240 Higher score = poor outcomes
Change in Measure of NDBI Strategy Implementation-Caregiver Change
Time frame: Week 12
21 items on a 1-5 scale Minimum score: 21 Maximum score: 105 Lower score = poorer strategy implementation
Measure Fidelity
Time frame: Week 12
Completed weekly until community provider participants reach 80% fidelity. The form consists of a 15 point questionnaire completed by the trainer, which was created by the study team. The score for each item = NA, 0, 1 or 2. Max fidelity score 24-30 (3 items can be scored as NA meaning not applicable or no opportunity.)
Provider Knowledge Gain
Time frame: Week 12
Administered before and after synchronous training session conducted by study intervention team to measure community provider participant's knowledge of the training topics. The measure consists of 8 multiple choice questions and 15 short answer questions. Completion of the questionnaires informs provider baseline knowledge as well as future modifications to the training curriculum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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.
Jessica Simacek, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDBI in people with Autism Spectrum Disorder, run by University of Minnesota 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?
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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Simacek, PhD (612-624-1450, sima0034@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Observation of Social Communication Change (BOSCC) (time frame: Week 12). 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 9 Apr 2026.