ClinicalTrials.gg
CompletedNCT01513915Updated Apr 26, 2016

A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study

An interventional study of Group cognitive behavioral intervention in Anxiety Disorders, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-04-26.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety Disorders

Browse trials for

Keywords

  • parents
  • group cognitive behavioral intervention
  • anxiety disorder
  • children
  • FRIENDS program
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    A parent only group CBT

    There was a Group cognitive behavioral intervention -based on parent training component of "FRIENDS" program- for parents of children with anxiety disorders who were allocated to intervention group.

    Other: Group cognitive behavioral intervention

  • No intervention
    Waiting list group

    Parents of children with anxiety disorders who met the inclusion criteria and gave written informed consent and were allocated to wait list group.

Interventions

  • OtherGroup cognitive behavioral intervention

    A Group cognitive behavioral intervention \_based on parent training component of FRIENDS program\_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions. Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.

06

What researchers measure

Primary outcomes

  1. Revised Children's Manifest Anxiety (RCMA)

    This self report questionnaire consists of 28 items assessing a child's chronic or trait anxiety and 9 items assessing social desirability or potential lying. The RCMA has achieved a high internal consistency and moderate test-retest reliability.

    Time frame: up to 30 minutes

Secondary outcomes

  1. Children's Depression Inventory (CDI)

    This self report inventory has 27 items related to the cognitive, affective and behavioral signs of depression. The scale has high internal consistency and moderate test-retest reliability

    Time frame: 20 minutes

  2. Depression-Anxiety-Stress Scale (DASS)

    This is a 42 item self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. The DASS was shown to possess satisfactory psychometric properties.45-47 Parents completed this scale about their own negative emotional states

    Time frame: 20 minutes

  3. Children Global Assessment Scale (CGAS)

    This Scale was developed to be a more child-specific measure of functioning. This measure is currently used in diagnosis, treatment, and evaluation of children's mental health problems to determine eligibility to receive mental health services and document treatment outcome status

    Time frame: 15 minutes

  4. Assessment of Consumer Satisfaction

    Post treatment, parents in the intervention group completed a satisfaction questionnaire to rate how useful the program was in controlling their own anxiety, in managing their child anxious behavior, in improving family relations, the likelihood they would attend the treatment program again if needed, and if they would recommend the program to others on a 1 (not recommend) to 7 (highly recommend) likert scale

    Time frame: 25 minutes

  5. Strengths and Difficulties Questionnaire (SDQ) Home Version

    This questionnaire is a parent report of psychopathology in children and adolescents. The scale consists of 25 items which generates five subscale scores (Emotional Symptoms, Conduct Problems, Inattention/Hyperactivity, Peer Problems and Prosocial Behavior) and a Total Difficulties Score. We used the SDQ Emotional Symptoms Scale (SDQ-Em) as a parent measure of child anxiety. SDQ has adequate internal consistency (α=0.37) and good test-retest reliability (r=0.62).42-44 The validity and reliability of SDQ has been confirmed in community samples of Iranian children and adolescents

    Time frame: [Time Frame: 30 minutes]

  6. Global Relational Assessment of Functioning (GRAF)

    It provides a measure of the quality of functioning based on a review of three major areas: problem-solving, organization, and the emotional atmosphere. Available psychometric evidence suggests that clinician and even non clinician raters can achieve good to excellent reliability with only minimal training. The validity of the GRAF is supported by expected correlations with other measures of family and couple distress and functioning

    Time frame: [Time Frame: 15 minutes]

07

Study locations

1 site
  • Rouzbeh Hospital
    Tehran, Tehran Province 13333, Iran
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01513915
Responsible party
Zahra Shahrivar (Assistant Professor, Tehran University of Medical Sciences) — Principal investigator
First posted
Jan 20, 2012
Start date
Jul 2008
Primary completion
May 2009
Completion
Jul 2009
Last update
Apr 26, 2016

Study contacts

Zahra Shahrivar, MD
study chair · Tehran University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion