Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
not yet recruiting
Estimated enrollment
50 participants
Study completion date
December 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 20, 2026
Actual (reported)
First Posted
October 27, 2026
Actual (reported)
Study Start
November 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Digital single -session intervention (SSI)AcceptabilityFeasibilityUtilityWeb-based
Outcome Measures
Primary Outcomes (4)
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.
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.
baseline, 2-weeks, 4-weeks, 8-weeks
Study Arms (1)
EMPOWER-ND
EXPERIMENTAL
Participants will receive the EMPOWER-ND intervention to assist children struggling with anxious avoidance
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.
EMPOWER-ND
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
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.
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.
baseline, 2-weeks, 4-weeks, 8-weeks
Feasibility of the program
Completion rates will be used to assess feasibility.
baseline, 2-weeks, 4-weeks, 8-weeks
Secondary Outcomes (1)
Assessment of anxiety and related disorders
baseline 2-weeks, 4-weeks, 8-weeks
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
Contact the study team to confirm eligibility.
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Abnormalities, Multiple
Congenital Abnormalities
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
X-Linked Intellectual Disability
Sex Chromosome Disorders
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Movement Disorders
Central Nervous System Diseases
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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