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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.

Interventions

Remote, intensive intervention for injection phobiaBehavioral

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 baselineThree week baselineTwo week baseline

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Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Masking Details

No masking

Purpose

TREATMENT

Intervention Model

PARALLEL

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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

One week baseline

Two week baseline

Three week baseline

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

One week baseline

Two week baseline

Three week baseline

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations