Cognitive Behavioral Therapy With Parental Involvement for Treating Children With Anxiety Disorders
Parent Mediation of Child Anxiety CBT Outcome
3 other identifiers
interventional
341
1 country
1
Brief Summary
This study will compare the effectiveness of individual cognitive behavioral therapy with two distinct types of parent involvement versus individual cognitive behavioral therapy without parent involvement in treating children with anxiety disorders. Hypothesized mediator of change for eac of the two parent treatment conditions also will be evaluated
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
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
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 2, 2017
July 1, 2017
8.3 years
February 20, 2008
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician Severity Rating on the Anxiety Disorders Interview Schedule for Children (ADIS C/P)
Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
Secondary Outcomes (1)
Child Manifest Anxiety Scale for Children, Revised
Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
Study Arms (3)
1
EXPERIMENTALParticipants will receive individual cognitive behavioral therapy with parent reinforcement training.
2
EXPERIMENTALParticipants will receive individual cognitive behavioral therapy with parent relationship training.
3
ACTIVE COMPARATORParticipants will receive individual cognitive behavioral therapy alone.
Interventions
ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
Parent relationship training will teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
Parent reinforcement training will teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder, including generalized anxiety disorder (GAD), social phobia (SOP), and social anxiety disorder (SAD), as confirmed by ADIS C/P
- Receives a mean score of 4 or greater on the Clinician's Rating Scale of Severity (CSR)
- Willing to stop all other child psychosocial treatment upon study entry
- Comorbid attention deficit hyperactivity disorder (ADHD) and depressive disorders with CSR scores less than 4 are acceptable if treated and stable
- Tics or aggression/impulse control problems with minimal or no impairment are acceptable if treated and stable
- If taking medication, on stable medication treatment for comorbid ADHD, major depressive disorder, tics, or aggression/impulse control
- Agreement of parents or guardians to participate in the child participant's treatment
- Child living with a primary caregiver who has known the child well for at least 6 months and who is legally able to give consent for the child's participation
You may not qualify if:
- Meets as a primary diagnosis any Axis I DSM-IV disorder other than GAD, SOP, and SAD
- Child and/or parent meets diagnoses (e.g., primary, secondary, tertiary) for any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, schizophrenia, and other psychotic disorders
- Child and/or parent shows high likelihood and/or serious intent of hurting self or others
- Full-scale IQ score less than 80
- Victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Florida International University
Miami, Florida, 33139, United States
Related Publications (1)
Patriarca GC, Rey Y, Marin CE, Yeguez CE, Pettit JW, Silverman WK. Parent involvement enhances CBTs for anxiety disorders in Hispanic/Latino youth: Acculturation as a moderator. J Consult Clin Psychol. 2022 Oct;90(10):827-836. doi: 10.1037/ccp0000770.
PMID: 36355650DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy K. Silverman, PhD
Florida International University
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 22, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 2, 2017
Record last verified: 2017-07