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

NCT04972006 | Unknown

• 1 other identifier: 5992
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disorder of Childhood

Keywords

intensive treatment; remote treatment; cognitive bias; measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Remote Treatment Acceptability/Feasibility measure

  This measure will be administered at the two week follow-up timepoint.

• Measure of the acceptability and feasibility of cognitive bias tasks

  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

  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

  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

  This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.

Study Arms (3)

One week baseline

EXPERIMENTAL

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

Behavioral: Remote, intensive intervention for injection phobia

Two week baseline

EXPERIMENTAL

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

Behavioral: Remote, intensive intervention for injection phobia

Three week baseline

EXPERIMENTAL

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

Behavioral: Remote, intensive intervention for injection phobia

Interventions

Remote, intensive intervention for injection phobia 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.

One week baseline; Three week baseline; Two week baseline

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Officials

• Alicia Fenley, MA

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia R Fenley, MA

CONTACT

8502943327; afenley@bu.edu

Donna Pincus, PhD

CONTACT

6173539610; dpincus@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share