Investigating the Effects of Parent Component to Cognitive Behavior Therapy (CBT) for Youth With Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title:

Investigating the Effects of an Added Parent Component to Cognitive Behavior Therapy for Youth With Anxiety Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02160444
• Other study ID #: 2012-05-0009
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2013
• Last updated: June 5, 2015
• Start date: June 2012
• Est. completion date: July 2016

Study information

• Verified date: June 2015
• Source: University of Texas at Austin
• Contact: Kevin D Stark, Ph.D.
• Phone: 512-324-3315
• Email: kstark[@]austin.utexas.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Investigation is designed to determine whether the gold standard for treating anxious youth is enhanced by teaching parents to become their anxious child's CBT coach. Children (7-17 years old) with either Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety Disorder are treated with a combination of the Coping Cat Program and a parent-training intervention that is designed to teach the child's parents the same cognitive and behavioral skills that the child is learning and how to help their child to complete exposure activities. The research methods are parallel to those used in the CAMS study so that this data can be merged with that data set to evaluate the relative efficacy of the enhanced intervention.

Description:

Children between the ages of 7 and 17 years old who are primarily experiencing either Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia and are not experiencing a cognitive or learning disability that would prevent them from validly completing the measures are eligible for participation in the study. Children who are experiencing another psychological disorder as their primary disorder would be excluded from the current investigation. Outcome measures include the ADIS for Diagnostic and Statistical Manual (fourth edition)(DSM-IV( Child or Parent, Children's Global Improvement Scale (CGI-I), Children's Global Assessment Scale (CGAS), Pediatric Anxiety Rating Scale (PARS), Negative Affect Self-Statements Questionnaire (NASSQ), Coping Questionnaire (CQ), Goal Attainment Scale (GAS), Mood and Feelings Questionnaire (MFQ), Multi-dimensional Anxiety Scale for Children (MASC), Screen for Child Anxiety and Related Emotional Disorders (SCARED),Family Assessment Measure (third editions) (FAM-III Dyadic), Perception of Therapeutic Relationship (PTR), Satisfaction Questionnaire (SQ), Child Behavior Check List (CBCL), Family Burden Assessment Scale (BAS), Brief Symptom Index (BSI), State Trait Anxiety Inventory (STAI), Brief Family Assessment Measure (third editions (Brief FAM-III).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Child is between 7-17 years old

• Primary diagnosis of Generalized Anxiety Disorder

• Separation Anxiety Disorder, or Social Phobia.

Exclusion Criteria:

• Presence of Major Depression, suicidal risk, presence of a learning disability or cognitive deficit that would prevent the child from validly completing the measures

• Presence of another psychological disorder that is of primary significance

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• CBT plus Parent as CBT Coach Training
Standard CBT for treatment of anxiety disorders in youth is completed by the children while their primary caregiver receives training in the same cognitive behavioral skills, how to recognize when he or she is accommodating his or her child's anxiety, and how to create and implement exposure activities.

Locations

Country	Name	City	State
United States	Texas Child Study Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perception of Therapeutic Relationship measures the participants' satisfaction with the therapeutic relationship at post-treatment and at the one year and two year follow-ups.	Assesses the patient-therapist relationship from the patient's perspective.	Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Other	Satisfaction Questionnaire measures the degree of satisfaction the participants experience at post-treatment and at one and two year follow-up assessments.	Assesses the extent to which the patients are satisfied with the treatment they received.	Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Primary	Pediatric Anxiety Rating Scale measures change in severity of anxiety from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Interview measure of the severity of anxiety symptoms that is completed by the child and his or her primary caregiver.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Primary	Multidimensional Anxiety Scale for Children measures change in severity of anxiety from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Measure of severity of anxiety symptoms in children and adolescents.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Primary	Screen for Child Anxiety Related Emotional Disorders measures change in severity of anxiety and related co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Measure of the severity of anxiety symptoms.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Primary	Clinical Global Severity and Improvement Scales measure change in severity of anxiety and co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Assessment of initial severity of illness and extent of improvement over treatment and follow-ups.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Primary	Children's Global Assessment Scale measures change in severity of anxiety and co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Assessment of the degree of overall functioning of the child participants.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Primary	Anxiety Disorders Schedule for DSM-IV: Child Version and Parent Version	Interview measure of the presence and severity of various anxiety disorders and common co-existing disorders.	Baseline(One week prior to starting treatment)	Yes
Secondary	Family Assessment Measure III, Dyadic Relationship Scale measures change in perceived family environment from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Assess family relationships	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Child Behavior Checklist measures change in severity of internalizing and externalizing symptoms from the parent's perspective from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Broadband measure of child psychopathology	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Family Burden Assessment measures change in severity of the burden the child's anxiety disorder creates for the family from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Measure of the impact on the family of the child's anxiety disorder.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Brief Symptom Inventory measures change in severity of parental psychopathology from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Assess parental psychopathology	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	State Trait Anxiety Inventory measures change in severity of anxiety for parents from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Measures anxiety symptoms in parents.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Mood and Feelings Questionnaire measures change in severity of depressive symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Measure of depressive symptoms in the child participants	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Goal Attainment Scale measures goal attainment from baseline to post-treatment and assess maintenance of goal attainment at one year and two year follow-up assessments.	Therapist sets five goals for the child patient and then tracks progress over the course of treatment.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Coping Questionnaire measures change in coping skills from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Assess for the presence of coping skills in the child participants.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Negative Affective Self-Statement Questionnaire measures change in negative cognitions from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Measure of negative cognitions in the child participants.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	No
Secondary	Harm to Self and Others Interview measures change in suicidal ideation, homicidal ideation and self-harming behaviors from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.	Assessment of suicidal, homicidal and self-harm behavior and ideation.	Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)	Yes

External Links

•   Link for the Texas Child Study Center