Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks

Study Overview
=================
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.

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

Conditions
-----------------
Anxiety Disorder of Childhood

Intervention / Treatment
-----------------
* Behavioral: Remote, intensive intervention for injection phobia


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One week baseline<br>Participants randomized to baseline one will go through a one-week baseline period before beginning the treatment. | Behavioral: Remote, intensive intervention for injection phobia<br>* The intervention consists of a 1.5 hour session that provides youth with education about anxiety and a 3 to 4 hour session consisting of graduated exposure to injection fear.<br>|
| Experimental: Two week baseline<br>Participants randomized to baseline two will go through a two-week baseline period before beginning the treatment. | Behavioral: Remote, intensive intervention for injection phobia<br>* The intervention consists of a 1.5 hour session that provides youth with education about anxiety and a 3 to 4 hour session consisting of graduated exposure to injection fear.<br>|
| Experimental: Three week baseline<br>Participants randomized to baseline three will go through a three-week baseline period before beginning the treatment. | Behavioral: Remote, intensive intervention for injection phobia<br>* The intervention consists of a 1.5 hour session that provides youth with education about anxiety and a 3 to 4 hour session consisting of graduated exposure to injection fear.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fear and Avoidance Ratings | Participants will rate their level of fear and avoidance in response to the hypothetical scenario of needing to get a shot. This measure consists of two items, both rated on a scale from 0 (not at all) to 8 (very, very much). The study is interested in looking at the changes in these ratings from the baseline period to the post treatment and two-week follow-up period. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remote Treatment Acceptability/Feasibility measure | This measure was adapted for the current study, but is based on the Perceptions of Treatment Questionnaire (Mattis & Ollendick, 1997). The current measure assesses parent's perceptions of the speed, convenience, and helpfulness of the study treatment. The measure consists of 15 items, 11 of which are rated on a Likert scale and 4 of which are free response items. The likert scale items are rated on a 7-point scale, from extremely not (0) to extremely (6). | This measure will be administered at the two week follow-up timepoint. | 
| Measure of the acceptability and feasibility of cognitive bias tasks | This measure was developed for the purposes of the current study and obtains participants' perspectives about the length, comprehensibility, ease of use, construct validity, and entertainment value of the attentional, interpretation, and memory bias tasks. This measure includes both Likert scale response (9-pt. scale from 0, not at all to 8, very, very much) and free-response items to gain a comprehensive picture of the strengths and limitations of the newly adapted or developed cognitive bias tasks. This measure contains three subscales, each of which corresponds to one of the three cognitive bias tasks (attentional, interpretation, memory). The attentional bias task subscale contains 11 items, the interpretation bias subscale contains 8 items, and the memory bias subscale contains 9 items. The total scale consists of 28 items. | This measure will be administered at the two week follow-up timepoint. | 
| Analysis of test-retest reliability and treatment sensitivity of the attentional bias task | Once data collection is complete, it will be possible to analyze the test-retest reliability of the attentional bias task. This will be accomplished by assessing the association between attentional bias indices at pre-treatment and at the beginning of the first session, before treatment has been introduced. Additionally, it will be possible to inspect the treatment sensitivity of the attentional bias task by assessing the difference in magnitude of attentional bias indices before treatment and after treatment at the two-week follow-up time-point. | This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint. | 
| Analysis of test-retest reliability and treatment sensitivity of the interpretation bias task | Once data collection is complete, it will be possible to analyze the test-retest reliability of the interpretation bias task. This will be accomplished by assessing the association between interpretation bias indices at pre-treatment and at the beginning of the first session, before treatment has been introduced. Additionally, it will be possible to inspect the treatment sensitivity of the interpretation bias task by assessing the difference in magnitude of interpretation bias indices before treatment and after treatment at the two-week follow-up time-point. | This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint. | 
| Analysis of test-retest reliability and treatment sensitivity of the memory bias task | Once data collection is complete, it will be possible to analyze the test-retest reliability of the memory bias task. This will be accomplished by assessing the association between the memory bias index at pre-treatment and at the beginning of the first session, before treatment has been introduced. Additionally, it will be possible to inspect the treatment sensitivity of the memory bias task by assessing the difference in magnitude of the memory bias index before treatment and after treatment at the two-week follow-up time-point. | This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote treatment, cognitive bias, measurement, intensive treatment