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

NCT ID: NCT04972006

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2022-06-30

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.

Conditions

Anxiety Disorder of Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One week baseline

Participants randomized to baseline one will go through a one-week baseline period before beginning the treatment.

Group Type: EXPERIMENTAL

Remote, intensive intervention for injection phobia

Intervention Type: BEHAVIORAL

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.

Two week baseline

Participants randomized to baseline two will go through a two-week baseline period before beginning the treatment.

Group Type: EXPERIMENTAL

Remote, intensive intervention for injection phobia

Intervention Type: BEHAVIORAL

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.

Three week baseline

Participants randomized to baseline three will go through a three-week baseline period before beginning the treatment.

Group Type: EXPERIMENTAL

Remote, intensive intervention for injection phobia

Intervention Type: BEHAVIORAL

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.

Interventions

Remote, intensive intervention for injection phobia

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alicia Fenley, MA

Role: PRINCIPAL_INVESTIGATOR

Boston University

Central Contacts

Alicia R Fenley, MA

Role: CONTACT

afenley@bu.edu

8502943327

Donna Pincus, PhD

Role: CONTACT

dpincus@bu.edu

6173539610

Other Identifiers

5992

Identifier Type: -

Identifier Source: org_study_id