Anxiety DisordersNCT00509951
Parent-Augmented Cognitive Behavioral Therapy to Treat Children With Specific Phobias
A study testing One-session exposure treatment and Augmented one-session exposure treatment in people with Anxiety Disorders and Specific Phobia, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
This study will compare the effectiveness of two types of cognitive behavioral therapy, one-session exposure treatment and family-enhanced one-session exposure treatment, in treating children with specific phobias. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Anxiety Disorders, Specific Phobia
- What is being tested?
- One-session exposure treatment and Augmented one-session exposure treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2012
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in a regular classroom setting
- Possess at least an average intellectual ability as documented by school ability records
- Meets DSM-IV criteria for specific phobia and scores 4 or above on the clinician severity rating scale of the ADIS-C/P
- A parent or caregiver agrees to participate in the treatment
- Parent or guardian willing to provide informed consent
Who cannot join
- Significant medical disorder (e.g., cerebral palsy, deafness) that would interfere with study participation
- Already receiving psychological treatment (with the exception of minimal intervention in the school setting)
- Currently receiving psychotropic medication for a psychological disorder, with the exception of attention deficit hyperactivity disorder (ADHD). If the child is receiving stimulant or other medication for management of ADHD symptoms, it must be documented that pharmacological treatment has been stabilized.
- Blood-injection-injury type of specific phobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmented Treatment of Specific Phobias in Children
This study will compare the effectiveness of two types of cognitive behavioral therapy, one-session exposure treatment and family-enhanced one-session exposure treatment, in treating children with specific phobias.
Read the detailed description
A specific phobia is a fear of a particular object or situation. For many children, phobias result in considerable academic difficulties, social and personal distress, and interference in day-to-day activities. Physical symptoms typically accompany the intense anxiety caused by a specific phobia and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Phobias can persist a lifetime and may lead to other adult anxiety, mood, and substance use disorders. One-session exposure treatment (OST), a form of cognitive behavior therapy, has been considered a rapid and effective treatment for adults with a variety of specific phobias. Upward of 75 to 80% of adults treated with OST were considered diagnoses free following treatment. OST has proven useful in treating some children with specific phobias but not all. It is possible that parental factors may affect whether a child continues to experience a phobia and how well a child responds to treatment. For example, parents who are overly protective or have a phobia themselves may prevent their child from overcoming a specific phobia. Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. This study will compare the effectiveness of OST and augmented OST in treating children with specific phobias. This study will also evaluate how parental factors influence the expression and maintenance of phobias in children.
Participants in this study will be randomly assigned to receive OST or augmented OST. Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner. This treatment will only be delivered to the child and will not involve a parent or guardian. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session. During this session, parents will first be educated on specific phobias, including why phobias occur and how they are maintained over time. Next, parents will observe their child being treated from behind a one-way mirror for about 1 hour. During this time, a therapist will explain what the child's therapist is doing and discuss ways for parents to implement the treatment at home. Parents will then be asked to join their child and the therapist for the last hour of the child's session to assist the therapist with treatment.
Outcomes will be assessed for all participants immediately after treatment and at 1-, 6-, and 12-month follow-up evaluations during which the presence of specific phobias will be measured. Parents will also be asked to provide information about their child's school grades and school attendance for the year prior to participating in the study and up to 1 year after the child completes the treatment. The child's teacher may be asked to complete a questionnaire regarding the child's behavior in school. All of the information collected will help to determine how much progress each child has made as a result of treatment.
- Conditions
- Anxiety Disorders, Specific Phobia
- Being tested
- One-session exposure treatment, Augmented one-session exposure treatment
- Keywords
- Neuroses, Evidence-Based Treatment, Clinical Investigation, Young Patients, Phobic Disorders, Fear, Phobias
- Medical subject headings
- Anxiety Disorders, Phobia, Specific, Neurotic Disorders, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-session exposure treatmentBehavioural
Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner.
Augmented one-session exposure treatmentBehavioural
Also called Family-enhanced OST
Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | One-session exposure treatment (OST) Receives: Behavioral: One-session exposure treatment |
| 2 | Experimental | Family-enhanced (augmented) OST Receives: Behavioral: Augmented one-session exposure treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia
Measured: Measured at Year 1
Clinical Global Impression: Severity of Specific Phobia
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2012
- Study completionMay 2012
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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas H. Ollendick, Virginia Polytechnic Institute and State University
- Investigators
- Thomas H. Ollendick, PhD, Principal investigator, Department of Psychology, Virginia Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509951
- Sponsor's protocol ID
- R01MH074777
- Other IDs
- R01MH074777, DSIR 84-CTS
- Status last verified
- Jun 2013
- First submitted
- 30 Jul 2007
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Treatment of Specific Phobias in Children
- ClinicalTrials.gov ID
- NCT00509951
- Acronym / sponsor ID
- R01MH074777
- Conditions
- Anxiety Disorders, Specific Phobia
- Keywords
- Neuroses, Evidence-Based Treatment, Clinical Investigation, Young Patients, Phobic Disorders, Fear, Phobias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 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 compare the effectiveness of two types of cognitive behavioral therapy, one-session exposure treatment and family-enhanced one-session exposure treatment, in treating children with specific phobias.
Detailed description
A specific phobia is a fear of a particular object or situation. For many children, phobias result in considerable academic difficulties, social and personal distress, and interference in day-to-day activities. Physical symptoms typically accompany the intense anxiety caused by a specific phobia and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Phobias can persist a lifetime and may lead to other adult anxiety, mood, and substance use disorders. One-session exposure treatment (OST), a form of cognitive behavior therapy, has been considered a rapid and effective treatment for adults with a variety of specific phobias. Upward of 75 to 80% of adults treated with OST were considered diagnoses free following treatment. OST has proven useful in treating some children with specific phobias but not all. It is possible that parental factors may affect whether a child continues to experience a phobia and how well a child responds to treatment. For example, parents who are overly protective or have a phobia themselves may prevent their child from overcoming a specific phobia. Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. This study will compare the effectiveness of OST and augmented OST in treating children with specific phobias. This study will also evaluate how parental factors influence the expression and maintenance of phobias in children.
Participants in this study will be randomly assigned to receive OST or augmented OST. Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner. This treatment will only be delivered to the child and will not involve a parent or guardian. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session. During this session, parents will first be educated on specific phobias, including why phobias occur and how they are maintained over time. Next, parents will observe their child being treated from behind a one-way mirror for about 1 hour. During this time, a therapist will explain what the child's therapist is doing and discuss ways for parents to implement the treatment at home. Parents will then be asked to join their child and the therapist for the last hour of the child's session to assist the therapist with treatment.
Outcomes will be assessed for all participants immediately after treatment and at 1-, 6-, and 12-month follow-up evaluations during which the presence of specific phobias will be measured. Parents will also be asked to provide information about their child's school grades and school attendance for the year prior to participating in the study and up to 1 year after the child completes the treatment. The child's teacher may be asked to complete a questionnaire regarding the child's behavior in school. All of the information collected will help to determine how much progress each child has made as a result of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: One-session exposure treatmentOne-session exposure treatment (OST) |
| 2 | Experimental | Behavioral: Augmented one-session exposure treatmentFamily-enhanced (augmented) OST |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Enrolled in a regular classroom setting
- Possess at least an average intellectual ability as documented by school ability records
- Meets DSM-IV criteria for specific phobia and scores 4 or above on the clinician severity rating scale of the ADIS-C/P
- A parent or caregiver agrees to participate in the treatment
- Parent or guardian willing to provide informed consent
Key exclusion criteria (4 listed)
- Significant medical disorder (e.g., cerebral palsy, deafness) that would interfere with study participation
- Already receiving psychological treatment (with the exception of minimal intervention in the school setting)
- Currently receiving psychotropic medication for a psychological disorder, with the exception of attention deficit hyperactivity disorder (ADHD). If the child is receiving stimulant or other medication for management of ADHD symptoms, it must be documented that pharmacological treatment has been stabilized.
- Blood-injection-injury type of specific phobia
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 |
|---|---|---|
| One-session exposure treatmentParticipants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner. | Behavioural | 1 |
| Augmented one-session exposure treatmentAlso: Family-enhanced OSTFamily-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session. | Behavioural | 2 |
Primary outcome
Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia
Time frame: Measured at Year 1
Clinical Global Impression: Severity of Specific Phobia
Time frame: Measured at Year 1
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 7 Jun 2013.
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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.
Thomas H. Ollendick, PhD principal investigator
Department of Psychology, Virginia Tech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-session exposure treatment and Augmented one-session exposure treatment in people with Anxiety Disorders and Specific Phobia, run by Virginia Polytechnic Institute and State University 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 5 inclusion and 4 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 7 Jun 2013. 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?
Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia (time frame: Measured at Year 1). The study lists 2 primary outcomes in all. 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 7 Jun 2013.