Anxiety DisordersNCT01513915
A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
A study testing Group cognitive behavioral intervention in people with Anxiety Disorders, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Group cognitive behavioral intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Jul 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
- age 6 to 12 years,
- 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,
- at least one parent willing to participate and give written consent.
Who cannot join
- diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
- there was a change in drug regime during the study period,
- if parents missed more than 2 of 6 sessions of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study
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.
- Conditions
- Anxiety Disorders
- Being tested
- Group cognitive behavioral intervention
- Keywords
- parents, group cognitive behavioral intervention, anxiety disorder, children, FRIENDS program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group cognitive behavioral interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A parent only group CBT | Active comparator | 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. Receives: Other: Group cognitive behavioral intervention |
| Waiting list group | No intervention | Parents of children with anxiety disorders who met the inclusion criteria and gave written informed consent and were allocated to wait list group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 minutes
Secondary outcomes (6)
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
Measured: 20 minutes
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
Measured: 20 minutes
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
Measured: 15 minutes
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
Measured: 25 minutes
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
Measured: [Time Frame: 30 minutes]
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
Measured: [Time Frame: 15 minutes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJul 2008
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Shahrivar, Tehran University of Medical Sciences
- Investigators
- Zahra Shahrivar, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513915
- Sponsor's protocol ID
- Parent CBT for Anxiety
- Status last verified
- Apr 2016
- First submitted
- 16 Jan 2012
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study
- ClinicalTrials.gov ID
- NCT01513915
- Acronym / sponsor ID
- Parent CBT for Anxiety
- Conditions
- Anxiety Disorders
- Keywords
- parents, group cognitive behavioral intervention, anxiety disorder, children, FRIENDS program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A parent only group CBT | Active comparator | Other: Group cognitive behavioral interventionThere 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. |
| Waiting list group | No intervention | –Parents of children with anxiety disorders who met the inclusion criteria and gave written informed consent and were allocated to wait list group. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
- age 6 to 12 years,
- 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,
- at least one parent willing to participate and give written consent.
Key exclusion criteria (3 listed)
- diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
- there was a change in drug regime during the study period,
- if parents missed more than 2 of 6 sessions of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group cognitive behavioral interventionA 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. | Other | A parent only group CBT |
Primary outcome
Revised Children's Manifest Anxiety (RCMA)
Time frame: up to 30 minutes
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.
6 secondary outcomes
Children's Depression Inventory (CDI)
Time frame: 20 minutes
Depression-Anxiety-Stress Scale (DASS)
Time frame: 20 minutes
Children Global Assessment Scale (CGAS)
Time frame: 15 minutes
Assessment of Consumer Satisfaction
Time frame: 25 minutes
Strengths and Difficulties Questionnaire (SDQ) Home Version
Time frame: [Time Frame: 30 minutes]
Global Relational Assessment of Functioning (GRAF)
Time frame: [Time Frame: 15 minutes]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
Related trials for Anxiety Disorders
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra Shahrivar, MD study chair
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group cognitive behavioral intervention in people with Anxiety Disorders, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Children's Manifest Anxiety (RCMA) (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.