Trials Sponsors Conditions Drugs Pricing

Conditions

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

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

Interventions

Supportive Parenting for Anxious Childhood EmotionsBehavioral

12 sessions with parents

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Educational SupportBehavioral

12 sessions with parents

Parent Educational Support (PES)

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Prepubertal
Clinical diagnosis of primary anxiety disorder

Sponsors & Collaborators

Yale University
Otherlead
National Institute of Mental Health (NIMH)
NIHcollaborator

Study Sites (1)

Yale University Child Study Center

New Haven, Connecticut, 06519, United States

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title: Eli Lebowitz, PhD
Organization: Yale University

Study Officials

Eli R Lebowitz, PhD
Yale University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

214 participants (actual enrollment reported by the registry).

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

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Supportive Parenting for Anxious Childhood Emotions (SPACE)

Parent Educational Support (PES)

Cognitive Behavioral Therapy (CBT)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations