Anxiety Disorder of ChildhoodNCT04972006
Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks
A study testing Remote, intensive intervention for injection phobia in people with Anxiety Disorder of Childhood, run by Boston University Charles River Campus at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Anxiety Disorder of Childhood
- What is being tested?
- Remote, intensive intervention for injection phobia
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Charles River Campus
Boston, Massachusetts, 02215
About this study
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
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.
Read the 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
- Being tested
- Remote, intensive intervention for injection phobia
- Keywords
- intensive treatment, remote treatment, cognitive bias, measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote, intensive intervention for injection phobiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| One week baseline | Experimental | Participants randomized to baseline one will go through a one-week baseline period before beginning the treatment. Receives: 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. Receives: 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. Receives: Behavioral: Remote, intensive intervention for injection phobia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This analysis will include data points from the pre-baseline assessment, the beginning of the first session, and the two week follow-up timepoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start15 Jul 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Fenley, MA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972006
- Sponsor's protocol ID
- 5992
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04972006
- Acronym / sponsor ID
- 5992
- Conditions
- Anxiety Disorder of Childhood
- Keywords
- intensive treatment, remote treatment, cognitive bias, measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| One week baseline | Experimental | Behavioral: Remote, intensive intervention for injection phobiaParticipants randomized to baseline one will go through a one-week baseline period before beginning the treatment. |
| Two week baseline | Experimental | Behavioral: Remote, intensive intervention for injection phobiaParticipants randomized to baseline two will go through a two-week baseline period before beginning the treatment. |
| Three week baseline | Experimental | Behavioral: Remote, intensive intervention for injection phobiaParticipants randomized to baseline three will go through a three-week baseline period before beginning the treatment. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote, intensive intervention for injection phobiaThe 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. | Behavioural | One week baseline, Three week baseline, Two week baseline |
Primary outcome
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.
5 secondary outcomes
Remote Treatment Acceptability/Feasibility measure
Time frame: 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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Fenley, MA principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote, intensive intervention for injection phobia in people with Anxiety Disorder of Childhood, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.