Clinical trial NCT01513915: A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
Official title: A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: parents
group cognitive behavioral intervention
anxiety disorder
children
FRIENDS program
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for children with anxiety disorders (AD) is undeniable. However, most children with AD have limited access to CBT. There is some controversial evidence on group CBT in AD involving families in treatment of their children and a published article on efficacy of a parent only group CBT for these children. Considering these data, the investigators hypothesized that teaching anxiety-fighting skills to parents of children with AD would diminish anxiety symptoms of both parents and children and improve family relational functioning.

Detailed description: All children and their parents were interviewed using K-SADS-PL-Persian Version, a semi-structured diagnostic interview to confirm the diagnoses and assess possible comorbidities. All diagnostic assessments were conducted by a fellowship of child and adolescent psychiatry. Following assessment, once the participants reached twenty members, they were invited to complete child and parent self-report measures. The level of child functioning and family relationship functioning were also evaluated. Then they were randomly allocated to either parent training (N=20) or a 6 week wait-list (N=22) groups. During 2 weeks after treatment the assessments were repeated and satisfaction ratings were collected for the intervention group.

Eligibility criteria: Inclusion Criteria:

1. having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
2. age 6 to 12 years,
3. receiving one of selective serotonin reuptake inhibitor (SSRI) medicine at the stable dose for at least 8 weeks before baseline assessments and during the study,
4. at least one parent willing to participate and give written consent.

Exclusion Criteria:

1. diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
2. there was a change in drug regime during the study period,
3. if parents missed more than 2 of 6 sessions of treatment.

Primary outcomes:
measure: Revised Children's Manifest Anxiety (RCMA)
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Children's Depression Inventory (CDI)
timeFrame: 20 minutes
measure: Depression-Anxiety-Stress Scale (DASS)
timeFrame: 20 minutes
measure: Children Global Assessment Scale (CGAS)
timeFrame: 15 minutes
measure: Assessment of Consumer Satisfaction
timeFrame: 25 minutes
measure: Strengths and Difficulties Questionnaire (SDQ) Home Version
timeFrame: [Time Frame: 30 minutes]
measure: Global Relational Assessment of Functioning (GRAF)
timeFrame: [Time Frame: 15 minutes]
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rouzbeh Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Zahra Shahrivar, MD
role: STUDY_CHAIR
References: