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Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT03585010
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33).

Condition or disease Intervention/treatment Phase
Anxiety Disorder of Childhood Separation Anxiety Disorder of Childhood Social Anxiety Disorder of Childhood Generalized Anxiety Disorder Behavioral: Supportive Parenting for Anxious Childhood Emotions Behavioral: Parent Educational Support Behavioral: Cognitive-Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessments will conducted by independent evaluators, blind to treatment condition.
Primary Purpose: Treatment
Official Title: Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Supportive Parenting for Anxious Childhood Emotions
Parent-based treatment for childhood anxiety disorders
Behavioral: Supportive Parenting for Anxious Childhood Emotions
12 sessions with parents

Active Comparator: Parent Educational Support or CBT
Parent-based intervention for childhood anxiety disorders (phase 1) or child based treatment for childhood anxiety disorders (phase 2)
Behavioral: Parent Educational Support
12 sessions with parents

Behavioral: Cognitive-Behavioral Therapy
12 sessions with child




Primary Outcome Measures :
  1. Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 12 weeks ]

    The PARS is a clinician-administered measure of anxiety severity in children and adolescents.

    Total scores on PARS are used as indicator of anxiety severity. Total scores range from 0-35, with higher scores indicating more severe anxiety.



Secondary Outcome Measures :
  1. Multimodal Anxiety Scale for Children (MASC) [ Time Frame: 12 weeks ]

    The MASC is a self-report measure of anxiety severity, completed by children and parents separately.

    MASC generates a total anxiety score and several sub scales:

    Total scores: range from 0-150 Separation/Phobias scores: range from 0-27 Generalized anxiety scores: range from 0-30 Social anxiety scores: range from 0-27 Obsessive-compulsive symptom scores: 0-50 Physical symptoms scores: 0-60 For Total score and all sub-scales, higher scores indicate more severe anxiety.




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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prepubertal
  • Clinical diagnosis of primary anxiety disorder
  • Must not have another mental illness more impairing than the most impairing anxiety disorder
  • IQ of at least 80.

Exclusion Criteria:

  • Neurological disorders (including seizures)
  • Organic mental disorders, psychotic disorders, or pervasive developmental disorders
  • High likelihood of hurting themselves or others
  • Current psychosocial or psychopharmacological treatment
  • History of neurological illness or head injury with loss of consciousness > 5 minutes
  • Vision or physical disability that interferes with seeing stimuli presented briefly on computer screen and/or clicking a mouse button rapidly and repeatedly
  • Contraindications for MRI scanning (e.g., metal implants, pacemakers, braces, claustrophobia, pregnancy, weight > 250 pounds).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585010


Locations
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United States, Connecticut
Yale University Child Study Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Eli R Lebowitz, Ph.D.    203-785-7905    eli.lebowitz@yale.edu   
Sponsors and Collaborators
Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03585010     History of Changes
Other Study ID Numbers: 2000023649
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual participant data for primary and secondary measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available six months after study completion
Access Criteria: Data access requests will be reviewed by review panel and requestors will sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
anxiety disorders

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Phobic Disorders
Neurodevelopmental Disorders