An interventional study of EMPOWER-ND in Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD), sponsored by Boston University Charles River Campus. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Supportive care
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.
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.
337 studies on the registry are indexed under Neurodevelopmental Disorders; 142 are open to participants now.
This study's planned enrollment of 50 is below the median of 89 across 208 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →Boston University Charles River Campus is the lead sponsor of 157 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants will receive the EMPOWER-ND intervention to assist children struggling with anxious avoidance
Other: EMPOWER-ND
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 2-weeks, 4-weeks, 8-weeks
Feasibility of the program
Completion rates will be used to assess feasibility.
Time frame: baseline, 2-weeks, 4-weeks, 8-weeks
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.
Time frame: baseline 2-weeks, 4-weeks, 8-weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 137 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 52. This study's planned 13 months is below that.
Counting every sponsor, half of 141 studies reached it within 33 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Neurodevelopmental Disorders →
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