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

Anxiety Disorders Clinical Trial

Official title:

Parent Mediation of Child Anxiety CBT Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620958
• Other study ID #: R01MH079943
• Secondary ID: R01MH079943DSIR
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: July 31, 2017
• Start date: August 2008
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Individual cognitive behavioral therapy (ICBT)
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 (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)
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 (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)
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.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Child Manifest Anxiety Scale for Children, Revised		Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up