Neurodevelopmental DisordersEMPOWER-NDNCT07898592
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
A study testing EMPOWER-ND in people with Neurodevelopmental Disorders and Autism Spectrum Disorder (ASD), run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study will inform the development of a brief online program to help parents better understand and respond to anxiety-related behaviors in children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), intellectual disability, and learning… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- EMPOWER-ND
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult parent or primary caregiver of a child between the ages of 5-14 years.
- The child has a clinical diagnosis of a neurodevelopmental disorder, such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), or a related neurodevelopmental condition.
- Resides in the United States.
- Able to read and understand English, as the survey and study materials are provided in English.
- Has reliable internet connectivity and access to a device that can accommodate videoconferencing
Who cannot join
- If any of the inclusion criteria are not met
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
Boston University Charles River Campus
Boston, Massachusetts, 02215
Jenna Sung, PhD, 617-353-1503, jensung@bu.edu
About this study
Official title: Project EMPOWER-Neuro Developmental Disabilities (ND): Single Session Support for Parents of Children Struggling With Anxious Avoidance
This study will inform the development of a brief online program to help parents better understand and respond to anxiety-related behaviors in children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), intellectual disability, and learning disorders). Many neurodiverse children experience high levels of anxiety, which can appear as avoidance, emotional distress, or challenging behaviors that are difficult for parents to interpret and manage.
The purpose of this research is to evaluate EMPOWER-ND with its digital, single-session intervention (SSI) that provides practical parenting strategies for addressing anxiety-related behaviors in neurodiverse children. Parents of eligible children aged 5-14 with neurodevelopmental conditions will be invited to enroll in the research study.
Read the detailed description
A pilot study will be conducted to test the feasibility and preliminary effectiveness of EMPOWER-ND to improve individual-level variables. Project EMPOWER-ND is a modified version of the original, evidence-based Project EMPOWER, a web-based, SSI to reduce caregiver accommodation and promote approach-oriented caregiving for children with anxiety. Project EMPOWER-ND builds parent capacity to identify child avoidance behavior, attempts to accommodate child avoidance, and sample responses at various levels of challenge, to promote child approach behavior.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), Intellectual Disability, Learning Disorder, Communication Disorders
- Being tested
- EMPOWER-ND
- Keywords
- Digital single -session intervention (SSI), Acceptability, Feasibility, Utility, Web-based
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Intellectual Disability, Learning Disabilities, Communication Disorders, Down Syndrome, Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWER-NDOther
The intervention has 5 core components: (1) psychoeducation on anxiety in the context of neurodiversity; (2) psychoeducation on the cycle of anxious avoidance and accommodation; (3) identifying "sweet spot" challenges; (4) teaching validation and empathy for encouragement; and (5) how to troubleshoot common challenges.
| Study group | Role | What they receive |
|---|---|---|
| EMPOWER-ND | Experimental | Participants will receive the EMPOWER-ND intervention to assist children struggling with anxious avoidance Receives: Other: EMPOWER-ND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of program content
This outcome will be assessed by responses on the Program Feedback Scale (PFS), a 7-item self-report questionnaire to measure youth and participant acceptability, feasibility, and satisfaction with digital single-session interventions (SSIs). Response format is a 5-point Likert scale (Strongly Disagree (1) to Strongly Agree (5)). Total scores range from 7 to 35, with higher scores associated with greater program acceptability.
Measured: baseline, 2-weeks, 4-weeks, 8-weeks
Utility of the program
Utility will be assessed by the Family Accommodation Scale - Anxiety (FASA) questionnaire. FASA is a 9-item measure of how often family members change their own behavior to help a child avoid or ease anxiety. Each item is rated from 0 (never) to 4 (daily). Total score ranges from 0 to 36, with higher scores meaning more accommodation.
Measured: baseline, 2-weeks, 4-weeks, 8-weeks
Child avoidance behaviors
Child Avoidance Measure-Parent Report (CAMP), an 8-item questionnaire about how often the child avoids situations that make them anxious, scared, or worried. Each item is rated from 0 (almost never) to 3 (almost always), and items are summed for a total score from 0 to 24. Higher scores reflect greater avoidance.
Measured: baseline, 2-weeks, 4-weeks, 8-weeks
Feasibility of the program
Completion rates will be used to assess feasibility.
Measured: baseline, 2-weeks, 4-weeks, 8-weeks
Secondary outcomes (1)
Assessment of anxiety and related disorders
Anxiety and Related Disorders Interview Schedule (ADIS), a semi-structured clinical interview used to evaluate, diagnose, and measure the mood, obsessive-compulsive, trauma, and related disorders, will be administered to assess this outcome. It uses a Clinician Severity Rating (CSR) scale from 0 (none) to 8 (very severe), where scores of 4 or higher generally indicate a clinical diagnosis.
Measured: baseline 2-weeks, 4-weeks, 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenna Sung, PhD, Principal investigator, BU Charles River Campus, Counseling Psychology & Applied Human Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898592
- Sponsor's protocol ID
- 8709E
- Acronym
- EMPOWER-ND
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project EMPOWER-Neuro Developmental Disabilities (ND): Single Session Support for Parents of Children Struggling With Anxious Avoidance
- ClinicalTrials.gov ID
- NCT07898592
- Acronym / sponsor ID
- EMPOWER-ND / 8709E
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), Intellectual Disability, Learning Disorder, Communication Disorders
- Keywords
- Digital single -session intervention (SSI), Acceptability, Feasibility, Utility, Web-based
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 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.
This study will inform the development of a brief online program to help parents better understand and respond to anxiety-related behaviors in children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), intellectual disability, and learning disorders). Many neurodiverse children experience high levels of anxiety, which can appear as avoidance, emotional distress, or challenging behaviors that are difficult for parents to interpret and manage.
The purpose of this research is to evaluate EMPOWER-ND with its digital, single-session intervention (SSI) that provides practical parenting strategies for addressing anxiety-related behaviors in neurodiverse children. Parents of eligible children aged 5-14 with neurodevelopmental conditions will be invited to enroll in the research study.
Detailed description
A pilot study will be conducted to test the feasibility and preliminary effectiveness of EMPOWER-ND to improve individual-level variables. Project EMPOWER-ND is a modified version of the original, evidence-based Project EMPOWER, a web-based, SSI to reduce caregiver accommodation and promote approach-oriented caregiving for children with anxiety. Project EMPOWER-ND builds parent capacity to identify child avoidance behavior, attempts to accommodate child avoidance, and sample responses at various levels of challenge, to promote child approach behavior.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPOWER-ND | Experimental | Other: EMPOWER-NDParticipants will receive the EMPOWER-ND intervention to assist children struggling with anxious avoidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult parent or primary caregiver of a child between the ages of 5-14 years.
- The child has a clinical diagnosis of a neurodevelopmental disorder, such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), or a related neurodevelopmental condition.
- Resides in the United States.
- Able to read and understand English, as the survey and study materials are provided in English.
- Has reliable internet connectivity and access to a device that can accommodate videoconferencing
Key exclusion criteria (1 listed)
- If any of the inclusion criteria are not met
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 |
|---|---|---|
| EMPOWER-NDThe intervention has 5 core components: (1) psychoeducation on anxiety in the context of neurodiversity; (2) psychoeducation on the cycle of anxious avoidance and accommodation; (3) identifying "sweet spot" challenges; (4) teaching validation and empathy for encouragement; and (5) how to troubleshoot common challenges. | Other | EMPOWER-ND |
Primary outcome
Acceptability of program content
Time frame: baseline, 2-weeks, 4-weeks, 8-weeks
This outcome will be assessed by responses on the Program Feedback Scale (PFS), a 7-item self-report questionnaire to measure youth and participant acceptability, feasibility, and satisfaction with digital single-session interventions (SSIs). Response format is a 5-point Likert scale (Strongly Disagree (1) to Strongly Agree (5)). Total scores range from 7 to 35, with higher scores associated with greater program acceptability.
Utility of the program
Time frame: baseline, 2-weeks, 4-weeks, 8-weeks
Utility will be assessed by the Family Accommodation Scale - Anxiety (FASA) questionnaire. FASA is a 9-item measure of how often family members change their own behavior to help a child avoid or ease anxiety. Each item is rated from 0 (never) to 4 (daily). Total score ranges from 0 to 36, with higher scores meaning more accommodation.
Child avoidance behaviors
Time frame: baseline, 2-weeks, 4-weeks, 8-weeks
Child Avoidance Measure-Parent Report (CAMP), an 8-item questionnaire about how often the child avoids situations that make them anxious, scared, or worried. Each item is rated from 0 (almost never) to 3 (almost always), and items are summed for a total score from 0 to 24. Higher scores reflect greater avoidance.
Feasibility of the program
Time frame: baseline, 2-weeks, 4-weeks, 8-weeks
Completion rates will be used to assess feasibility.
1 secondary outcome
Assessment of anxiety and related disorders
Time frame: baseline 2-weeks, 4-weeks, 8-weeks
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 27 Oct 2026.
- 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.
Jenna Sung, PhD principal investigator
BU Charles River Campus, Counseling Psychology & Applied Human Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER-ND in people with Neurodevelopmental Disorders and Autism Spectrum Disorder (ASD), run by Boston University Charles River Campus 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 5 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: opening soon, as of the sponsor's last update on 27 Oct 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 Jenna Sung, PhD (617-353-1503, jensung@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of program content (time frame: baseline, 2-weeks, 4-weeks, 8-weeks). The study lists 4 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 27 Oct 2026.