Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)

NCT02310152 | Completed

• 2 other identifiers: 13110130205K23MH103555-03
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.

Conditions

Anxiety Disorders; Anxiety, Separation; Phobic Disorders

Keywords

Child; Adolescent; Parents; Cognitive Therapy; Cognitive Behavior Therapy; Anxiety

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impression Scale Improvement and Severity

  Clinician determined rating of illness

  After 12 weeks of treatment

• Pediatric Anxiety Rating Scale

  Clinician administered rating of child anxiety

  After 12 weeks of treatment

Secondary Outcomes (1)

• Screen for Childhood Anxiety Related Disorders

  After 12 weeks of treatment

Study Arms (2)

Active Treatment: CBT

ACTIVE COMPARATOR

Cognitive Behavioral Therapy

Behavioral: CBT

Experimental Treatment: SPACE

EXPERIMENTAL

Parent-Based Treatment of Childhood and Adolescent Anxiety Disorders

Behavioral: Parent-Based Treatment of Child and Adolescent Anxiety Disorders

Interventions

Parent-Based Treatment of Child and Adolescent Anxiety Disorders BEHAVIORAL

Supportive Parenting for Anxious Childhood Emotions

Also known as: SPACE

Experimental Treatment: SPACE

CBT BEHAVIORAL

Cognitive Behavioral Therapy

Active Treatment: CBT

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children:
• meet criteria for a primary DSM5 anxiety disorder of generalized anxiety disorder (GAD), social phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the Anxiety Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P)
• mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of Severity (CSR)
• ceasing all other psychosocial treatment upon consultation with the clinic staff and the service provider
• not using any psychotropic medication other than a stable dose of stimulant medication treatment for comorbid ADHD or a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI)
• children who are on a stable dose of stimulant medication or SSRI (i.e., a minimum of six weeks at the same dose) will be included so as not to limit generalizability.

You may not qualify if:

• Children:
• primary diagnosis of any Axis I DSM-IV disorder other than GAD, SOP, Phobias and SAD
• any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders
• Significant active suicidal ideation or a past suicide attempt in the last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g., cutting) will be allowed to enroll if they meet other criteria
• have an intellectual disability as reported by guardian
• be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
• not have been cohabiting with mother for at least one year prior to admittance. Parent:
• not have been cohabiting with child for at least one year prior to admittance
• report the presence of any active suicidal ideation or a past suicide attempt in the last 6 months.

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

Related Publications (3)

• Lebowitz, E. R., Omer, H., Hermes, H., & Scahill, L. (2013). Parent Training for Childhood Anxiety Disorders: The SPACE Program. Cognitive and Behavioral Practice.

  BACKGROUND

• Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.

  PMID: 22965863 BACKGROUND

• Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.

  PMID: 30851397 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Anxiety, Separation; Phobic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

US (1)