NCT06339463

Brief Summary

Self-Distancing is a cognitive technique that involves a shift in self-talk characterized by replacing first-person (e.g., "I") with second- or third-person pronouns (i.e., "you", one's own name) to promote an adaptive, self-reflective stance in emotionally charged situations. This trial aims to help learn how self-distancing may increase behavioral approach during exposures. To find out if self-distancing works by helping children approach fear-inducing stimuli, the study will look at behaviors and physiological responses related to approach, as well as symptom severity, before and after this cognitive technique. The study hypothesizes that Self-Distancing will lead to greater increases in approach behaviors and a larger decrease in symptom severity compared to a control condition (first-person self-talk).

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

March 25, 2024

Last Update Submit

May 4, 2026

Conditions

Keywords

Self-distancingSpecific phobia

Outcome Measures

Primary Outcomes (4)

  • Behavioral Approach Test (BAT)

    The BAT will be utilized to evaluate participants' behavioral approach towards a spider before and after the exposure therapy session. Participants will be instructed to approach a spider, contained in a plastic container at the opposite end of the room, as quickly and closely as they can manage, stopping when their fear becomes overwhelming. The BAT outcomes will be assessed by the distance approached (marked on the floor), ranging from 0, where participants will refuse to enter the room or to move from the starting point- to 10 feet, where they will touch the spider with a fingertip.

    Immediately before and after intervention.

  • Spider Phobia Questionnaire (SPQ-C)

    The SPQ-C is a validated self-report assessment of spider fear for children 8-12 years, consisting of 29 true/false items, 8 of which are reversed-scored. Total scores range from 0 to 29. Higher scores indicate a greater degree of spider fear.

    At baseline (~1 week before the intervention) and immediately after the intervention.

  • Treatment Engagement and Adherence Ratings (TEARS)

    The TEARS is a brief questionnaire assessing youth and therapist reports of youth's adherence to their assigned exposure condition, and their approach toward the exposure. Adherence and engagement are rated on a Likert scale from 1-7, with higher scores indicating greater engagement and adherence.

    Immediately after the intervention.

  • Subjective Units of Distress Scale (SUDS)

    Subjective Units of Distress (SUDs) scale-a self-assessment tool that quantifies the intensity of an individual's distress. During BAT, participants will be asked to indicate their level of anxiety on a scale ranging from 0 "no distress" to 100 "extreme distress".

    Immediately before and after the intervention.

Secondary Outcomes (3)

  • Heart Rate Variability

    Immediately before and after the intervention.

  • Electrodermal activity

    Immediately before and after the intervention.

  • Electroencephalogram (EEG)

    Immediately before and after the intervention.

Other Outcomes (3)

  • Screen for Child Anxiety Related Disorders (SCARED)- Parent and Child

    At baseline (~1 week before intervention) and immediately after intervention.

  • Child Behavior Checklist (CBCL)

    This measure is completed by the child's caregiver at baseline (~1 week before the intervention).

  • Clinical Expectancy Questionnaire (CEQ)

    It will be applied immediately before the intervention.

Study Arms (2)

Self-Distancing

EXPERIMENTAL

Youth will be randomized to a BAT with Self-Distancing Intervention. In this arm, participants will be instructed to describe the exposure task from a self-distanced perspective (e.g., "Emily is going to touch the spider").

Behavioral: Self-Distancing Intervention

First-person self-talk

ACTIVE COMPARATOR

Youth will be randomized to a BAT with a control condition. In this arm, participants will be instructed to describe the exposure task from a self-immersed perspective (e.g.,"I'm going to touch the spider")

Behavioral: First-person self-talk

Interventions

In the Self Distancing Intervention condition, participants will be instructed to describe the exposure task from a self-distanced perspective (e.g., "Emily is going to touch the spider").

Self-Distancing

Youth will be randomized to a BAT with a control condition. In this arm, participants will be instructed to describe the exposure task from a self-immersed perspective (e.g., "I'm going to touch the spider")

First-person self-talk

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 7-12.99 years at the time of consent
  • Written informed consent by a parent/legal guardian and assent by the child
  • Clinically significant symptoms of specific phobia (i.e., spider phobia)
  • Fluent in English (Participant may be bilingual but must be able to speak and understand fluent English to participate in the study)

You may not qualify if:

  • Prior diagnosis of bipolar disorder
  • Prior diagnosis of psychotic disorders
  • Prior diagnosis of autism spectrum disorder
  • Active alcohol or substance dependence
  • Active suicidal ideation or suicidal behavior within the past 3 months prior to baseline assessment
  • Any major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma)
  • Any history of cognitive impairment or developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Wolitzky-Taylor KB, Horowitz JD, Powers MB, Telch MJ. Psychological approaches in the treatment of specific phobias: a meta-analysis. Clin Psychol Rev. 2008 Jul;28(6):1021-37. doi: 10.1016/j.cpr.2008.02.007. Epub 2008 Mar 7.

    PMID: 18410984BACKGROUND
  • Wetzer G, Ten Have M, de Graaf R, Batelaan NM, van Balkom AJLM. Specific Phobia: Risk Factor of Other Psychiatric Disorders. J Nerv Ment Dis. 2021 Jul 1;209(7):484-490. doi: 10.1097/NMD.0000000000001341.

    PMID: 33840768BACKGROUND
  • Ollendick, T.H. and N.J. King, Empirically Supported Treatments for Children and Adolescents: Advances Toward Evidence-Based Practice, in Handbook of Interventions that Work with Children and Adolescents. 2004. p. 1-25.

    BACKGROUND
  • Ollendick T, Allen B, Benoit K, Cowart M. The tripartite model of fear in children with specific phobias: assessing concordance and discordance using the behavioral approach test. Behav Res Ther. 2011 Aug;49(8):459-65. doi: 10.1016/j.brat.2011.04.003. Epub 2011 May 6.

    PMID: 21596371BACKGROUND
  • Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.

    PMID: 20855043BACKGROUND
  • Bushnell GA, Gaynes BN, Compton SN, Dusetzina SB, Olfson M, Sturmer T. Incident Substance Use Disorder Following Anxiety Disorder in Privately Insured Youth. J Adolesc Health. 2019 Oct;65(4):536-542. doi: 10.1016/j.jadohealth.2019.05.007. Epub 2019 Jul 17.

    PMID: 31326248BACKGROUND
  • Borkovec, T., T. Weerts, and D. Bernstein, Assessment of anxiety in handbook of behavioral assessment. 1997, New York, John Wiley and Sons, Inc.

    BACKGROUND
  • Barzilay R, White LK, Moore TM, Calkins ME, Taylor JH, Patrick A, Huque ZM, Young JF, Ruparel K, Pine DS, Gur RC, Gur RE. Association of anxiety phenotypes with risk of depression and suicidal ideation in community youth. Depress Anxiety. 2020 Sep;37(9):851-861. doi: 10.1002/da.23060. Epub 2020 Jun 5.

    PMID: 32500960BACKGROUND
  • Ahlen J, Ghaderi A. Dimension-specific symptom patterns in trajectories of broad anxiety: A longitudinal prospective study in school-aged children. Dev Psychopathol. 2020 Feb;32(1):31-41. doi: 10.1017/S0954579418001384.

    PMID: 30688179BACKGROUND

MeSH Terms

Conditions

Phobia, Specific

Study Officials

  • Kate D Fitzgerald, MD

    Professor of Psychiatry

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The rater will be blinded to which condition, self-distancing or control, child participants receive.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Youth (7-12.99 years) with DSM-5 specific phobia (e.g. spider phobia) will be randomized to SD or a control condition (first-person perspective). Self-distancing or control condition will be delivered over the course of one visit. These conditions will run in parallel.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations