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Cognitive Behavioral Therapy With Parental Involvement for Treating Children With Anxiety Disorders

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual cognitive behavioral therapy (ICBT)
Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)
Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Mediation, Outcome, CBT, Child Anxiety Intervention

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will receive individual cognitive behavioral therapy with parent reinforcement training.

Participants will receive individual cognitive behavioral therapy with parent relationship training.

Participants will receive individual cognitive behavioral therapy alone.

Outcomes

Primary Outcome Measures

Clinician Severity Rating on the Anxiety Disorders Interview Schedule for Children (ADIS C/P)

Secondary Outcome Measures

Child Manifest Anxiety Scale for Children, Revised

Full Information

First Posted
February 20, 2008
Last Updated
July 31, 2017
Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00620958
Brief Title
Cognitive Behavioral Therapy With Parental Involvement for Treating Children With Anxiety Disorders
Official Title
Parent Mediation of Child Anxiety CBT Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Anxiety disorders are among the most common emotional, behavioral, and mental disorders in children, affecting an estimated 1 out of every 10 children and adolescents. Symptoms of anxiety disorders include an excessive sense of worry, stress, and fear; headache; nausea; and impaired learning and concentration. If left untreated, anxiety disorders can lead to difficulties with school and relationships, substance abuse, and the persistence of anxiety problems into adulthood. Individual cognitive behavioral therapy (ICBT), in which children learn to cope with fears through behavior and thought modification, has been an effective form of treatment for children with anxiety disorders. Studies have indicated that ICBT involving children and parents may be more effective than ICBT involving only children for improving anxiety levels and long-term recovery rates. This study will compare the effectiveness of ICBT with either parent reinforcement training or parent relationship training versus ICBT without parent involvement in treating children with anxiety disorders. Participation in this study will last 15 months, with 3 months of treatment and 12 months of follow-up. Both parent and child participants will first undergo initial assessments that will include psychological questionnaires; a video-taped child-parent interaction session; and interviews about behaviors, psychological functioning, and problem situations. Participants will then be assigned randomly to one of three treatment groups: ICBT, ICBT with parent reinforcement training (PRT1), or ICBT with parent relationship training (PRT2). All participants will attend between 12 and 14 weekly treatment sessions, lasting 60 minutes each. During all sessions, child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. ICBT PRT1 and ICBT PRT2 sessions will also involve the parent and child working together. ICBT PRT1 will specifically 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 PRT2 will specifically teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. All participants will be asked to complete questionnaires throughout treatment, upon completion of treatment, and 6 months after the end of treatment. Three and 9 months after the end of treatment, participants will undergo a 15-minute telephone assessment to evaluate how the child participant has been doing. The final assessment will occur 12 months after the end of treatment and will include repeat interviews and questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Mediation, Outcome, CBT, Child Anxiety Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
341 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive individual cognitive behavioral therapy with parent reinforcement training.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive individual cognitive behavioral therapy with parent relationship training.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants will receive individual cognitive behavioral therapy alone.
Intervention Type
Behavioral
Intervention Name(s)
Individual cognitive behavioral therapy (ICBT)
Other Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician Severity Rating on the Anxiety Disorders Interview Schedule for Children (ADIS C/P)
Time Frame
Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
Secondary Outcome Measure Information:
Title
Child Manifest Anxiety Scale for Children, Revised
Time Frame
Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy K. Silverman, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33139
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36355650
Citation
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.
Results Reference
derived

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Cognitive Behavioral Therapy With Parental Involvement for Treating Children With Anxiety Disorders

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