- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04972006
Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks
July 12, 2021 updated by: Boston University Charles River Campus
Investigating the Acceptability, Feasibility, and Preliminary Efficacy of a Brief, Remote Treatment for Youth Injection Phobia and the Measurement of Cognitive Biases in Youth
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alicia R Fenley, MA
- Phone Number: 8502943327
- Email: afenley@bu.edu
Study Contact Backup
- Name: Donna Pincus, PhD
- Phone Number: 6173539610
- Email: dpincus@bu.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: One week baseline
Participants randomized to baseline one will go through a one-week baseline period before beginning the treatment.
|
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.
|
Experimental: Two week baseline
Participants randomized to baseline two will go through a two-week baseline period before beginning the treatment.
|
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.
|
Experimental: Three week baseline
Participants randomized to baseline three will go through a three-week baseline period before beginning the treatment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fear and Avoidance Ratings
Time Frame: 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.
|
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
Time Frame: This measure will be administered at the two week follow-up timepoint.
|
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
Time Frame: This measure will be administered at the two week follow-up timepoint.
|
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
Time Frame: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
|
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
Time Frame: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
|
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
Time Frame: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alicia Fenley, MA, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2021
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
June 16, 2021
First Submitted That Met QC Criteria
July 12, 2021
First Posted (Actual)
July 22, 2021
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 12, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No plan to share individual participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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