Autism Spectrum Disorder Clinical Trial
— CHILDOfficial title:
A Prospective Pilot Study to Characterize the Impact on Families of Electronic Tracking Device Use by Children With Autism Spectrum Disorders Who Wander
Verified date | January 2021 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated.
Status | Completed |
Enrollment | 31 |
Est. completion date | November 11, 2019 |
Est. primary completion date | November 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years of age - Parent of a child between the ages of 4 and 17 who currently has autism spectrum disorder (ASD), was diagnosed with ASD by a professional, and has wandered at least once in the preceding 3 months - Currently lives in the United States - Currently lives with child with ASD - Has been living with child with ASD for at least 6 months - Has reliable internet access to allow for completion of online questionnaires Exclusion Criteria: Current or past use of any electronic tracking device to address wandering behavior in the child with ASD |
Country | Name | City | State |
---|---|---|---|
United States | Cohen Children's Medical Center of New York | New Hyde Park | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Kiely B, Migdal TR, Vettam S, Adesman A. Prevalence and Correlates of Elopement in a Nationally Representative Sample of Children with Developmental Disabilities in the United States. PLoS One. 2016 Feb 4;11(2):e0148337. doi: 10.1371/journal.pone.0148337. eCollection 2016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of participant retention | Participant retention will be assessed to evaluate the feasibility of all study procedures. | 6 weeks | |
Primary | Rates of questionnaire completion | Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule. | 6 weeks | |
Primary | Adherence to the intervention | The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention. | 6 weeks | |
Secondary | Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores | The Caregiver Strain Questionnaire is a validated, 21-item instrument that was developed to measure the strain experienced by parents of children with emotional and behavioral disorders. A modified version of this questionnaire will be administered in order to evaluate parental strain due to wandering-related concerns. The questionnaire measures three dimensions of caregiver strain, including objective strain (11 items), internalized subjective strain (6 items), and externalized subjective strain (4 items). Each subscale score is calculated by averaging responses (on a five-point scale) to all items in the subscale. A global score is obtained by summing all three subscale scores, with higher scores indicating a greater degree of caregiver strain. | Baseline and Week 6 | |
Secondary | Changes from baseline in GAD-7 scores | The Generalized Anxiety Disorder 7-Item (GAD-7) scale is a validated measure of the severity of anxiety symptoms. Possible scores range from 0 to 21, with higher scores indicating more severe levels of anxiety. | Baseline, Week 6 | |
Secondary | Changes from baseline in BFDS scores | The Brief Family Distress Scale (BFDS) is a single-item measure for evaluating the experience of distress or crisis in families of children with developmental disabilities. Possible scores range from 1 to 10, with higher scores representing a greater degree of family distress. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | |
Secondary | Changes from baseline in the frequency of wandering-related disruptions to the household. | A weekly study-specific questionnaire will evaluate the perceived impact of the child's wandering behavior on parent, child, and family activities. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | |
Secondary | Perceived impact of the intervention | Study-specific questionnaires will assess the perceived impact of the intervention on the child's wandering behavior and on the well-being of the parent and child. | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |