Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-28 @ 11:52 PM
Study NCT ID:
NCT04972006
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks
Sponsor:
Boston University Charles River Campus
Organization:
Study Overview
Official Title:
Investigating the Acceptability, Feasibility, and Preliminary Efficacy of a Brief, Remote Treatment for Youth Injection Phobia and the Measurement of Cognitive Biases in Youth
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is investigating the acceptability, feasibility, and preliminary efficacy of a brief, remote treatment for youth injection phobia. It will also be examining the acceptability, feasibility, and initial psychometric properties of three cognitive bias measures adapted or newly developed for youth injection fear.
Detailed Description:
This study aims to investigate the acceptability, feasibility, and efficacy of a brief, remote treatment for youth injection phobia. There is a pressing need to increase the accessibility, reach, and efficacy of treatments for youth injection fear, as this fear affects approximately 11% of youth and can prevent them from receiving necessary medical procedures or vaccinations. Developing and validating the efficacy of treatments for youth injection fear that are time-efficient, convenient, and broadly accessible will facilitate more widespread targeting of this fear in youth, which could have a meaningful impact on youths' ability to receive medical treatments that involve injections or blood draws. Thus far, separate evidence bases have formed to support the efficacy of brief, intensive treatments for youth specific phobias and other anxiety disorders AND the efficacy of remotely delivered treatments for a range of youth anxiety disorders. However, studies have not yet combined these approaches to investigate their efficacy for treating youth injection phobia. The current study thus serves as the first to specifically examine the clinical utility of using a combined intensive and remote approach to treat youth injection phobia. Investigation into the treatment's impact on youth injection fear will be complemented by information, provided by youths' parents, about the treatment's convenience, acceptability, speed, suitability for the child's specific presentation, and overall helpfulness. Lastly, as a first step towards better understanding the cognitive processing variables that influence the development and maintenance of youth injection fear, the current study will examine the initial acceptability, feasibility, and psychometric properties of adapted or newly developed measures of attentional, interpretation, and memory bias. This study will use a multiple baseline design in which up to 18 youth will be randomly assigned to a one-, two-, or three-week baseline period before beginning the brief, remote intervention. Treatment will consist of two sessions in which the first session provides education about anxiety and lasts approximately 1.5 hours, and the second session consists of gradual exposure to injection-related stimuli and lasts approximately three to four hours. Throughout the study period, youth will complete various measures related to injection fear and related constructs as well as the cognitive bias tasks at three separate time-points.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: