Social Anxiety DisorderNCT02305537
Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment
A study testing McLean Anxiety Mastery Program in people with Social Anxiety Disorder and Specific Phobia, run by Mclean Hospital at 1 site in United States.
Trial summary
The collection of patient self-report and diagnostic data will allow us to examine the efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data gathered through routine clinical care, the investigators seek to explore whether patients in treatment show improvements from admission to… Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Social Anxiety Disorder, Specific Phobia, Separation Anxiety Disorder
- What is being tested?
- McLean Anxiety Mastery Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2024
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All youth who are eligible to participate in the McLean Anxiety Mastery Program will be invited to participate in the research study.
- Eligibility criteria for the McLean Anxiety Mastery Program include:
- children and adolescents who are between the ages of 6 and 19 and
- who present with at least one of the following disorders:
- Separation Anxiety Disorder,
- Social Anxiety Disorder,
Show all 11Show fewer
- Panic Disorder,
- Agoraphobia,
- Specific Phobia(s), and
- OCD.
- Interested and eligible patients and their caregivers should complete and submit an application (https://www.mcleanhospital.org/sites/default/files/2021-07/MAMP-Application-07032021_0.pdf) to begin the phone screen process.
Who cannot join
- Patients ineligible for the treatment program, and therefore the study, include those who have engaged in substance abuse during the six weeks prior to the first evaluation (i.e., waitlist or admission) the phone screening,
- those who report that they are unwilling to refrain from self-injurious behaviors during the waitlist and treatment periods,
- those who are experiencing active symptoms of psychosis,
- those who exhibit severe behavioral disinhibition or aggression, and
- those who express an intent and/or plan to commit suicide or homicide at the time of their first evaluation the initial phone screening.
- Patients must be fluent in English to participate in the program because all off-grounds exposure groups will be conducted in English (whenever possible, however, translation services will be provided for patients whose parents are not fluent in English).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building an Outcomes Assessment Infrastructure to Assess Youth in the McLean Anxiety Mastery Program at McLean Hospital
The collection of patient self-report and diagnostic data will allow us to examine the efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data gathered through routine clinical care, the investigators seek to explore whether patients in treatment show improvements from admission to discharge, compared to patients on the waitlist, and whether these gains are maintained three months post-discharge. The following are included as examples of some of the study's hypotheses.
Read the detailed description
The study population will involve all assenting/consenting patients, both male and female, admitted to the McLean Anxiety Mastery Program at McLean Hospital. This program provides intensive group-based treatment for anxious youth (aged 6-19). Patients in the McLean Anxiety Mastery Program participate in a minimum of four weeks of treatment and attend the program for four days per week. Three days per week, patients attend group-based treatment for two-and-a-half hours per day. The fourth day of each week consists of a one-hour group-based treatment, a one-hour family meeting, and a one-hour exposure session that includes children and their caregivers. One day per week, parents also attend a one-hour parent guidance group as part of the overall treatment package. Patients also have psychopharmacology consultations with the program psychiatrist on a case-by-case basis. On their first birthday that falls after the date of discharge, patients are sent a birthday card that includes a greeting and reminders about coping skills that they learned in the program.
The investigators expect to recruit at least 45 assenting/consenting patients in the first year of the study. The plan is to treat six-to-eight patients during each one-month module and to have a waitlist, if interest in the program exceeds the program's capacity. If a waitlist exists, patients, who are on this waitlist, will be evaluated as the study's control group once they are four weeks away from their target admission date.
Before the patient's first assessment through the program, a clinician will inform the patient and caregivers about the opportunity to participate in a voluntary research study at the McLean Anxiety Mastery Program. Assent/consent will be requested to utilize these data for research purposes. The patient and caregivers will be told that all of the information gathered from the child- and caregiver-report measures are part of routine clinical practice, and permission is being sought to use this de-identified data for research purposes. The patient and caregivers will be reminded that their decision to or not to participate in the research study will not affect the treatment they receive.
The assessments are conducted at the following time points: 1) upon admission, 2) weekly while the patients are participating in treatment, 3) upon discharge, and 4) at a three-month follow-up visit.
The child- and parent--report questionnaires are administered through REDCap Survey, a secure, HIPAA-compliant program for building and managing online surveys. The measures are completed on families' devices at home. If a patient or family member does not complete the online survey within 48 hours, a clinician will contact them with a reminder one time via phone or e-mail. The survey does not include questions assessing risk (e.g., for suicidal ideation, self-harm, substance use).
- Conditions
- Social Anxiety Disorder, Specific Phobia, Separation Anxiety Disorder, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder
- Being tested
- McLean Anxiety Mastery Program
- Medical subject headings
- Phobia, Social, Phobia, Specific, Anxiety, Separation, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McLean Anxiety Mastery ProgramBehavioural
Cognitive-Behavioral Therapy with Exposure and Response Prevention
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Cognitive-Behavioral Therapy) | Experimental | Participants in the McLean Anxiety Mastery Program Receives: Behavioral: McLean Anxiety Mastery Program |
| Waitlist | No intervention | Participants on the waitlist for the McLean Anxiety Mastery Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997).
The SCAS is a 44-item self-report inventory that measures anxiety severity.
Measured: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
Secondary outcomes (1)
Change in Score in Center for Epidemiolgic Studies Depression Scale (CES-D; Radloff 1977).
The CES-D is a 20-item self-report inventory that measures depression severity.
Measured: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2024
- Study completionNov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sperling, Jacqueline,Ph.D., Mclean Hospital
- Investigators
- Jacqueline Sperling, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305537
- Sponsor's protocol ID
- 2014P000353
- Status last verified
- Mar 2023
- First submitted
- 14 Nov 2014
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building an Outcomes Assessment Infrastructure to Assess Youth in the McLean Anxiety Mastery Program at McLean Hospital
- ClinicalTrials.gov ID
- NCT02305537
- Acronym / sponsor ID
- 2014P000353
- Conditions
- Social Anxiety Disorder, Specific Phobia, Separation Anxiety Disorder, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2024 (actual)
- Study completion
- Nov 2024 (actual)
- First posted
- 2 Dec 2014 (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 collection of patient self-report and diagnostic data will allow us to examine the efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data gathered through routine clinical care, the investigators seek to explore whether patients in treatment show improvements from admission to discharge, compared to patients on the waitlist, and whether these gains are maintained three months post-discharge. The following are included as examples of some of the study's hypotheses.
Detailed description
The study population will involve all assenting/consenting patients, both male and female, admitted to the McLean Anxiety Mastery Program at McLean Hospital. This program provides intensive group-based treatment for anxious youth (aged 6-19). Patients in the McLean Anxiety Mastery Program participate in a minimum of four weeks of treatment and attend the program for four days per week. Three days per week, patients attend group-based treatment for two-and-a-half hours per day. The fourth day of each week consists of a one-hour group-based treatment, a one-hour family meeting, and a one-hour exposure session that includes children and their caregivers. One day per week, parents also attend a one-hour parent guidance group as part of the overall treatment package. Patients also have psychopharmacology consultations with the program psychiatrist on a case-by-case basis. On their first birthday that falls after the date of discharge, patients are sent a birthday card that includes a greeting and reminders about coping skills that they learned in the program.
The investigators expect to recruit at least 45 assenting/consenting patients in the first year of the study. The plan is to treat six-to-eight patients during each one-month module and to have a waitlist, if interest in the program exceeds the program's capacity. If a waitlist exists, patients, who are on this waitlist, will be evaluated as the study's control group once they are four weeks away from their target admission date.
Before the patient's first assessment through the program, a clinician will inform the patient and caregivers about the opportunity to participate in a voluntary research study at the McLean Anxiety Mastery Program. Assent/consent will be requested to utilize these data for research purposes. The patient and caregivers will be told that all of the information gathered from the child- and caregiver-report measures are part of routine clinical practice, and permission is being sought to use this de-identified data for research purposes. The patient and caregivers will be reminded that their decision to or not to participate in the research study will not affect the treatment they receive.
The assessments are conducted at the following time points: 1) upon admission, 2) weekly while the patients are participating in treatment, 3) upon discharge, and 4) at a three-month follow-up visit.
The child- and parent--report questionnaires are administered through REDCap Survey, a secure, HIPAA-compliant program for building and managing online surveys. The measures are completed on families' devices at home. If a patient or family member does not complete the online survey within 48 hours, a clinician will contact them with a reminder one time via phone or e-mail. The survey does not include questions assessing risk (e.g., for suicidal ideation, self-harm, substance use).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (Cognitive-Behavioral Therapy) | Experimental | Behavioral: McLean Anxiety Mastery ProgramParticipants in the McLean Anxiety Mastery Program |
| Waitlist | No intervention | –Participants on the waitlist for the McLean Anxiety Mastery Program |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- All youth who are eligible to participate in the McLean Anxiety Mastery Program will be invited to participate in the research study.
- Eligibility criteria for the McLean Anxiety Mastery Program include:
Key exclusion criteria (6 listed)
- Patients ineligible for the treatment program, and therefore the study, include those who have engaged in substance abuse during the six weeks prior to the first evaluation (i.e., waitlist or admission) the phone screening,
- those who report that they are unwilling to refrain from self-injurious behaviors during the waitlist and treatment periods,
- those who are experiencing active symptoms of psychosis,
- those who exhibit severe behavioral disinhibition or aggression, and
- those who express an intent and/or plan to commit suicide or homicide at the time of their first evaluation the initial phone screening.
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 |
|---|---|---|
| McLean Anxiety Mastery ProgramCognitive-Behavioral Therapy with Exposure and Response Prevention | Behavioural | Treatment (Cognitive-Behavioral Therapy) |
Primary outcome
Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997).
Time frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
The SCAS is a 44-item self-report inventory that measures anxiety severity.
1 secondary outcome
Change in Score in Center for Epidemiolgic Studies Depression Scale (CES-D; Radloff 1977).
Time frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment
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 20 Oct 2025.
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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.
Jacqueline Sperling, Ph.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McLean Anxiety Mastery Program in people with Social Anxiety Disorder and Specific Phobia, run by Mclean 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 11 inclusion and 6 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 20 Oct 2025. 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?
Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997). (time frame: Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment). 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 20 Oct 2025.