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

NCT03585010 | Completed Results DMC

• 3 other identifiers: 20000236494R33MH115113-031R61MH115113-01A1
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety Disorder of Childhood; Separation Anxiety Disorder of Childhood; Social Anxiety Disorder of Childhood; Generalized Anxiety Disorder

Keywords

anxiety disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12.

  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.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Change From Baseline Anxiety Severity on the Multimodal Anxiety Scale for Children (MASC) at Week 12.

  Baseline and 12 weeks

Study Arms (3)

Supportive Parenting for Anxious Childhood Emotions (SPACE)

EXPERIMENTAL

Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.

Behavioral: Supportive Parenting for Anxious Childhood Emotions

Parent Educational Support (PES)

ACTIVE COMPARATOR

Parent Educational Support: 12 sessions with parents

Behavioral: Parent Educational Support

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

Cognitive-Behavioral Therapy: 12 sessions with child

Behavioral: Cognitive-Behavioral Therapy

Interventions

Supportive Parenting for Anxious Childhood Emotions BEHAVIORAL

12 sessions with parents

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Educational Support BEHAVIORAL

12 sessions with parents

Parent Educational Support (PES)

Cognitive-Behavioral Therapy BEHAVIORAL

12 sessions with child

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University Child Study Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Eli Lebowitz, PhD
• Organization: Yale University

eli.lebowitz@yale.edu

(203)785-7905

Study Officials

• Eli R Lebowitz, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will conducted by independent evaluators, blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: August 24, 2018
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (1)