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



Status:Active, not recruiting
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:8 - 11
Updated:8/10/2016
Start Date:August 2008
End Date:December 2016

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Parent Mediation of Child Anxiety CBT Outcome

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

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.

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
We found this trial at
1
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1001 Washington Avenue
Miami, Florida 33139
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Miami, FL
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