Anxiety DisordersNCT00517244
Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders
An observational study of Anxiety Disorders and Obsessive Compulsive Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Obsessive Compulsive Disorder
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Apr 2014
- Phase
- Observational
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community Sample
Who may be able to join
- English-speaking
Who cannot join
- Mental retardation
- Current or past diagnosis of autistic spectrum disorders
- Current or past diagnosis of psychotic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Anxiety Research Center/Bradley Hospital/Brown Medical School
Providence, Rhode Island, 02903
About this study
Official title: Child Anxiety Disorders: Parenting and Temperament Effects
This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders.
Read the detailed description
Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Effective treatments for anxiety disorders are available, and research continues to yield new, improved therapies that can help most people with anxiety disorders to lead productive, fulfilling lives. This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders. Results from this study may improve future treatment of children with anxiety disorders.
Families participating in this observational study will be mailed parent and child questionnaires that should be completed prior to the first study session. The child questionnaires will ask for information regarding the child's feelings and family interactions. Parent questionnaires will ask for information about their own personal feelings as well as the child's feelings, symptoms, and behaviors. Study participation will last 2 days. On the first day of the study, families will undergo a 3-hour diagnostic interview in which questions similar to those found on the questionnaires will be revisited. On the second day, mothers and their children will participate in three different observation tasks that explore how families interact and respond to certain situations. These tasks may include discussing certain anxiety-provoking situations, putting puzzles together, and creating an ending to a story. Before each task, the child will be placed alone in a separate room where the child will be asked to relax. Throughout the tasks, the child's heart rate and breathing will be recorded by a machine. The tasks will be videotaped but will be viewed only by research staff for data analysis purposes and to ensure that all safety procedures were followed. Upon study completion, if it appears that a child has an anxiety disorder, parents of the child will be notified and will receive treatment referrals as needed.
- Conditions
- Anxiety Disorders, Obsessive Compulsive Disorder
- Keywords
- Children, Healthy Controls, Assessment
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Primary anxiety disorder | |
| B | Primary obsessive compulsive disorder | |
| C | Healthy children with no previous history of an anxiety disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting styles and child temperaments associated with child anxiety disorders
Measured: Measured at completion of treatment analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2014
- Study completionApr 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Abbe Garcia, Rhode Island Hospital
- Investigators
- Abbe M. Garcia, PhD, Principal investigator, Brown Medical School/ Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517244
- Sponsor's protocol ID
- K23MH071754
- Other IDs
- K23MH071754, DDTR B3-PDX
- Status last verified
- Mar 2016
- First submitted
- 14 Aug 2007
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child Anxiety Disorders: Parenting and Temperament Effects
- ClinicalTrials.gov ID
- NCT00517244
- Acronym / sponsor ID
- K23MH071754
- Conditions
- Anxiety Disorders, Obsessive Compulsive Disorder
- Keywords
- Children, Healthy Controls, Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2006
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Aug 2007 (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.
This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders.
Detailed description
Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Effective treatments for anxiety disorders are available, and research continues to yield new, improved therapies that can help most people with anxiety disorders to lead productive, fulfilling lives. This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders. Results from this study may improve future treatment of children with anxiety disorders.
Families participating in this observational study will be mailed parent and child questionnaires that should be completed prior to the first study session. The child questionnaires will ask for information regarding the child's feelings and family interactions. Parent questionnaires will ask for information about their own personal feelings as well as the child's feelings, symptoms, and behaviors. Study participation will last 2 days. On the first day of the study, families will undergo a 3-hour diagnostic interview in which questions similar to those found on the questionnaires will be revisited. On the second day, mothers and their children will participate in three different observation tasks that explore how families interact and respond to certain situations. These tasks may include discussing certain anxiety-provoking situations, putting puzzles together, and creating an ending to a story. Before each task, the child will be placed alone in a separate room where the child will be asked to relax. Throughout the tasks, the child's heart rate and breathing will be recorded by a machine. The tasks will be videotaped but will be viewed only by research staff for data analysis purposes and to ensure that all safety procedures were followed. Upon study completion, if it appears that a child has an anxiety disorder, parents of the child will be notified and will receive treatment referrals as needed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | –Primary anxiety disorder |
| B | – | –Primary obsessive compulsive disorder |
| C | – | –Healthy children with no previous history of an anxiety disorder |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community Sample
Key inclusion criteria (1 listed)
- English-speaking
Key exclusion criteria (3 listed)
- Mental retardation
- Current or past diagnosis of autistic spectrum disorders
- Current or past diagnosis of psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parenting styles and child temperaments associated with child anxiety disorders
Time frame: Measured at completion of treatment analysis
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 11 Mar 2016.
- Click here for the Pediatric Anxiety Research Clinic Web siteLink provided by the sponsor.
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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.
Abbe M. Garcia, PhD principal investigator
Brown Medical School/ Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Obsessive Compulsive Disorder, run by Rhode Island Hospital at 1 site in United States.
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 1 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 11 Mar 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 United States. 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?
Parenting styles and child temperaments associated with child anxiety disorders (time frame: Measured at completion of treatment analysis). 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 11 Mar 2016.