Clinical trial NCT04972006: Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorder of Childhood
Keywords: intensive treatment
remote treatment
cognitive bias
measurement
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a multiple baseline design in which participants are assigned to either a one-week, two-week, or three-week baseline period before beginning the study treatment. Participants in all three baseline groups receive the same treatment, both in dose and form.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of specific phobia- blood, injection-injury subtype
* Age between 8 and 16
* Spoken and reading fluency in English
* Third grade reading ability
* Parental availability to participate in treatment study sessions
* Parental spoken and reading fluency in English.

Exclusion Criteria:

* A comorbid, previously assigned diagnosis of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), generalized anxiety disorder (GAD) OR significant parental endorsement of inattentiveness, hyperactivity, prolonged depressed mood, or pervasive generalized worries that are interfering with the child's life at the phone screen level
* A diagnosed learning disorder in reading or information processing
* Parent-reported child unwillingness or lack of ability to participate in cognitive bias tasks (e.g., looking at needle or injection-related imagery, reading basic stories about needles or blood draws)
* Previous and/or concurrent participation in CBT-based, exposure therapy for the fear of injections.

Primary outcomes:
measure: Change in Fear and Avoidance Ratings
timeFrame: This is a daily measure. Participants will complete it every day for the duration of the study period, which will range between 5 and 7 weeks depending on the participant's baseline assignment.
Secondary outcomes:
measure: Remote Treatment Acceptability/Feasibility measure
timeFrame: This measure will be administered at the two week follow-up timepoint.
measure: Measure of the acceptability and feasibility of cognitive bias tasks
timeFrame: This measure will be administered at the two week follow-up timepoint.
measure: Analysis of test-retest reliability and treatment sensitivity of the attentional bias task
timeFrame: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
measure: Analysis of test-retest reliability and treatment sensitivity of the interpretation bias task
timeFrame: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
measure: Analysis of test-retest reliability and treatment sensitivity of the memory bias task
timeFrame: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Alicia Fenley, MA
role: PRINCIPAL_INVESTIGATOR
References: