Anxiety DisordersNCT02651402
A Hybrid Effectiveness-Implementation Trial of Group CBT in Urban Schools
A study testing FRIENDS for Life, Adapted FRIENDS and Train-the-Trainer in people with Anxiety Disorders, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Unresolved psychological problems, such as anxiety, affect a significant number of our students and interfere with their ability to attend, actively participate, and prosper in school. Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- FRIENDS for Life, Adapted FRIENDS and Train-the-Trainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 28 Feb 2021
- 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 8 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Supervisors: Any participating agency clinical supervisor with a Master's degree or higher in a mental health field.
- Therapists: Any STS therapist with a Bachelor's degree or higher who provides services in one of the 18 participating schools.
- Students: Any student enrolled in grades 4-8 in one of the participating schools, who had been referred to the STS program in their school and who meets study screening and diagnostic criteria. The screening criterion is a Total score > 25 on Screen for Child Anxiety Related Disorders (SCARED) completed by a parent or school staff member. This student must also present a primary positive or intermediate diagnosis of Separation Anxiety Disorder (SAD]) Generalized Anxiety Disorder (GAD), or Social Phobia (SP) on the Anxiety Disorders Interview Schedule (ADIS); completed by a parent during the eligibility evaluation.
- If, at the conclusion of the eligibility evaluation, students do not meet diagnostic criteria (see above) to participate in the study, but parents and school staff continue to express concern about functional impairment, students will be permitted to participate in the intervention sessions (with parent permission). We also expect that there might be a very small number of eligible children whose parents may not give consent, and some of these parents and school personnel might want these children to benefit from the intervention. As such, we would like to offer these children the opportunity to participate along with the research subjects. This group of students will not be identified as "research subjects" and study data will not be collected from them. However, parents will be asked to sign a permission form for the video recording of the group sessions. This is the procedure we currently follow for our National Institute of Child Health and Human Development (NICHD) funded project, which has been approved by the Institutional Review Board (IRB) of The Children's Hospital of Philadelphia and School District of Philadelphia.
Who cannot join
- Supervisors or therapists not involved in STS.
- Students with Special Education classification of "Intellectual Disability;" children whose primary diagnosis is not SAD, GAS or SP.
- Students with a history of psychotic or autistic spectrum disorders according to school records.
- Students meeting criteria in #2 \& #3 above will be excluded from participation because they would be unlikely to benefit from Global Cognitive Behavioral Therapy (GCBTS).
- Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Hybrid Effectiveness-Implementation Trial of Group Cognitive Behavior Therapy (CBT) in Urban Schools
Unresolved psychological problems, such as anxiety, affect a significant number of our students and interfere with their ability to attend, actively participate, and prosper in school. This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Bachelor's or Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (Train-the-Trainer) or external consultants (Train the Trainer+).
Read the detailed description
Background/Purpose: This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (TT) or external consultants (TT+).
Population: 18 schools in Philadelphia will be chosen for participation. Students who present excessive anxiety in grades 4-8 would be potentially eligible to participate in the interventions offered by the agencies' therapists in their school.
Intervention: This study is designed to test: a) the effectiveness of an adapted version of a group cognitive behavioral therapy program (aFRIENDS) compared to the original version of this program (FRIENDS), and b) the effectiveness of two implementation support strategies for aFRIENDS: Train-the-Trainer and Train-the-Trainer Plus. aFRIENDS is a shorter, more culturally sensitive, focused, and feasible CBT for anxiety in children than FRIENDS and addresses one of the major barriers to implementation (intervention-context fit).
Design: Therapists and supervisors will be randomly assigned to one of three conditions: a) FRIENDS with Train-the-Trainer implementation strategy (i.e., Masters-level supervisors receive training by experts on conducting supervision); b) aFRIENDS with Train-the-Trainer strategy; c) aFRIENDS using the Train-the-Trainer Plus strategy (i.e., supervisors receive training and consultation by experts on conducting supervision).
Analyses: Effectiveness will be measured by comparing A to B; Implementation will be measured by comparing B to C. Agency therapists will conduct all treatment groups in the schools.
- Conditions
- Anxiety Disorders
- Being tested
- FRIENDS for Life, Adapted FRIENDS, Train-the-Trainer, Train-the-Trainer Plus
- Keywords
- Anxiety Disorders, Internalizing, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRIENDS for LifeBehavioural
Also called FRIENDS
Friends for Life (FRIENDS): FRIENDS, a GCBT program, is an effective program for the prevention and treatment of anxiety disorders in children evidenced by a meta-analysis on school-based interventions for at-risk and clinically anxious youth. FRIENDS was developed based on the view that anxiety is a tripartite construct involving physiological, cognitive, and behavioral components. Core Intervention components: Experts in CBT for childhood anxiety disorders have identified 5 essential components: psychoeducation, somatic management skills training, cognitive restructuring, exposure methods, and contingency management. The FRIENDS protocol consists of 10 weekly sessions and two booster sessions. We included the booster sessions in the regular protocol for a total of 12 sessions.
Adapted FRIENDSBehavioural
Also called aFRIENDS
Adapted Friends (aFRIENDS): We conducted planned adaptations to the FRIENDS protocol based on our collective experience with the protocol and qualitative data (focus group and interviews). We followed procedures developed by Lee and colleagues, including surveying service providers and trainers regarding the appropriateness of FRIENDS for the target population. Changes were made to the language (idioms, metaphors, words), cultural fit (cultural values), methods (session length, number of sessions), activities (in-session practices), which resulted in additions and substitutions in these areas while maintaining the 5 essential components of the treatment. aFRIENDS is a briefer (8-session) and more engaging and culturally-sensitive protocol than FRIENDS.
Train-the-TrainerBehavioural
Also called TT
Train the Trainer (TT): agency supervisors are trained to conduct effective supervision (one initial training and 2 booster sessions), and then go on to train intervention therapists.
Train-the-Trainer PlusBehavioural
Also called TT+
Train the Trainer Plus (TT+): a modified train-the-trainer approach by which supervisors receive training plus extended on-going consultation on conducting effective supervision with intervention therapists.
| Study group | Role | What they receive |
|---|---|---|
| FRIENDS for Life Train-the-Trainer | Active comparator | Therapists implement FRIENDS (a CBT protocol for students with anxiety) in the school setting, while supported by their supervisor assigned to the Train-the-Trainer (TT) implementation strategy (supervisors participate in training workshops on conducting supervision with active therapists). Receives: Behavioral: FRIENDS for Life; Behavioral: Train-the-Trainer |
| Adapted FRIENDS Train-the-Trainer | Experimental | Therapists implement an adapted version of FRIENDS (aFRIENDS) in the school setting while supported by their supervisor assigned to the TT strategy. Receives: Behavioral: Adapted FRIENDS; Behavioral: Train-the-Trainer |
| Adapted FRIENDS Train-the-Trainer Plus | Experimental | Therapists implement aFRIENDS in the school setting while supported by their supervisor assigned to the Train-the-Trainer Plus (TT+) implementation strategy (supervisors participate in training workshops and receive further/on-going consultation on conducting supervision with active therapists). Receives: Behavioral: Adapted FRIENDS; Behavioral: Train-the-Trainer Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Manifest Anxiety Scale for Children (MASC) from Baseline to Post Intervention completed by parents and children
Effectiveness between treatment groups will be assessed by comparing the change in diagnostic status from pre to post intervention. Diagnostic status will be assessed using the Anxiety Disorders Interview Schedule for Children (ADIS-P) which includes a semi-structured interview used to determine diagnostic status and outcome. Clinical judgement is used to generate a Clinician Severity Rating (CSR). A CSR >4 is a clinical diagnosis of an anxiety disorder, CSR=3 patient at risk for developing a disorder.
Measured: Up to 12 weeks
Secondary outcomes (1)
Cost Effectiveness
A Cost Benefit Analysis will be conducted across both interventions and implementation strategies, comparing material expenses, personnel effort, agency and school district salaries, etc.
Measured: Duration of Project (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo B Eiraldi, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651402
- Sponsor's protocol ID
- 15-012311
- Other IDs
- 1R01MH108555-01
- Status last verified
- Apr 2021
- First submitted
- 7 Jan 2016
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Eiraldi R, Lawson GM, Glick HA, Khanna MS, Beidas R, Fishman J, Rabenau-McDonnell Q, Wilson T, Comly R, Schwartz BS, Jawad AF. Implementation fidelity, student outcomes, and cost-effectiveness of train-the-trainer strategies for Masters-level therapists in urban schools: results from a cluster randomized trial. Implement Sci. 2024 Jan 25;19(1):4. doi: 10.1186/s13012-023-01333-9.
PubMed 38273369Lawson GM, Comly R, Beidas RS, Khanna MS, Goldstein J, Brizzolara-Dove S, Wilson T, Rabenau-McDonnell Q, Eiraldi R. Therapist and supervisor perspectives about two train-the-trainer implementation strategies in schools: A qualitative study. Implement Res Pract. 2023 Aug 3;4:26334895231190854. doi: 10.1177/26334895231190854. eCollection 2023 Jan-Dec.
PubMed 37790186Eiraldi R, Khanna MS, Jawad AF, Fishman J, Glick HA, Schwartz BS, Cacia J, Wandersman A, Beidas R. A hybrid effectiveness-implementation cluster randomized trial of group CBT for anxiety in urban schools: rationale, design, and methods. Implement Sci. 2016 Jul 12;11:92. doi: 10.1186/s13012-016-0453-z.
PubMed 27405587
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial of Group Cognitive Behavior Therapy (CBT) in Urban Schools
- ClinicalTrials.gov ID
- NCT02651402
- Acronym / sponsor ID
- 15-012311
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety Disorders, Internalizing, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Institute of Mental Health (NIMH)
- Study start
- Feb 2016
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Jan 2016 (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.
Unresolved psychological problems, such as anxiety, affect a significant number of our students and interfere with their ability to attend, actively participate, and prosper in school. This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Bachelor's or Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (Train-the-Trainer) or external consultants (Train the Trainer+).
Detailed description
Background/Purpose: This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (TT) or external consultants (TT+).
Population: 18 schools in Philadelphia will be chosen for participation. Students who present excessive anxiety in grades 4-8 would be potentially eligible to participate in the interventions offered by the agencies' therapists in their school.
Intervention: This study is designed to test: a) the effectiveness of an adapted version of a group cognitive behavioral therapy program (aFRIENDS) compared to the original version of this program (FRIENDS), and b) the effectiveness of two implementation support strategies for aFRIENDS: Train-the-Trainer and Train-the-Trainer Plus. aFRIENDS is a shorter, more culturally sensitive, focused, and feasible CBT for anxiety in children than FRIENDS and addresses one of the major barriers to implementation (intervention-context fit).
Design: Therapists and supervisors will be randomly assigned to one of three conditions: a) FRIENDS with Train-the-Trainer implementation strategy (i.e., Masters-level supervisors receive training by experts on conducting supervision); b) aFRIENDS with Train-the-Trainer strategy; c) aFRIENDS using the Train-the-Trainer Plus strategy (i.e., supervisors receive training and consultation by experts on conducting supervision).
Analyses: Effectiveness will be measured by comparing A to B; Implementation will be measured by comparing B to C. Agency therapists will conduct all treatment groups in the schools.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FRIENDS for Life Train-the-Trainer | Active comparator | Behavioral: FRIENDS for Life, Behavioral: Train-the-TrainerTherapists implement FRIENDS (a CBT protocol for students with anxiety) in the school setting, while supported by their supervisor assigned to the Train-the-Trainer (TT) implementation strategy (supervisors participate in training workshops on conducting supervision with active therapists). |
| Adapted FRIENDS Train-the-Trainer | Experimental | Behavioral: Adapted FRIENDS, Behavioral: Train-the-TrainerTherapists implement an adapted version of FRIENDS (aFRIENDS) in the school setting while supported by their supervisor assigned to the TT strategy. |
| Adapted FRIENDS Train-the-Trainer Plus | Experimental | Behavioral: Adapted FRIENDS, Behavioral: Train-the-Trainer PlusTherapists implement aFRIENDS in the school setting while supported by their supervisor assigned to the Train-the-Trainer Plus (TT+) implementation strategy (supervisors participate in training workshops and receive further/on-going consultation on conducting supervision with active therapists). |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Supervisors: Any participating agency clinical supervisor with a Master's degree or higher in a mental health field.
- Therapists: Any STS therapist with a Bachelor's degree or higher who provides services in one of the 18 participating schools.
- Students: Any student enrolled in grades 4-8 in one of the participating schools, who had been referred to the STS program in their school and who meets study screening and diagnostic criteria. The screening criterion is a Total score > 25 on Screen for Child Anxiety Related Disorders (SCARED) completed by a parent or school staff member. This student must also present a primary positive or intermediate diagnosis of Separation Anxiety Disorder (SAD]) Generalized Anxiety Disorder (GAD), or Social Phobia (SP) on the Anxiety Disorders Interview Schedule (ADIS); completed by a parent during the eligibility evaluation.
- If, at the conclusion of the eligibility evaluation, students do not meet diagnostic criteria (see above) to participate in the study, but parents and school staff continue to express concern about functional impairment, students will be permitted to participate in the intervention sessions (with parent permission). We also expect that there might be a very small number of eligible children whose parents may not give consent, and some of these parents and school personnel might want these children to benefit from the intervention. As such, we would like to offer these children the opportunity to participate along with the research subjects. This group of students will not be identified as "research subjects" and study data will not be collected from them. However, parents will be asked to sign a permission form for the video recording of the group sessions. This is the procedure we currently follow for our National Institute of Child Health and Human Development (NICHD) funded project, which has been approved by the Institutional Review Board (IRB) of The Children's Hospital of Philadelphia and School District of Philadelphia.
Key exclusion criteria (5 listed)
- Supervisors or therapists not involved in STS.
- Students with Special Education classification of "Intellectual Disability;" children whose primary diagnosis is not SAD, GAS or SP.
- Students with a history of psychotic or autistic spectrum disorders according to school records.
- Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.
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 |
|---|---|---|
| FRIENDS for LifeAlso: FRIENDSFriends for Life (FRIENDS): FRIENDS, a GCBT program, is an effective program for the prevention and treatment of anxiety disorders in children evidenced by a meta-analysis on school-based interventions for at-risk and clinically anxious youth. FRIENDS was developed based on the view that anxiety is a tripartite construct involving physiological, cognitive, and behavioral components. Core Intervention components: Experts in CBT for childhood anxiety disorders have identified 5 essential components: psychoeducation, somatic management skills training, cognitive restructuring, exposure methods, and contingency management. The FRIENDS protocol consists of 10 weekly sessions and two booster sessions. We included the booster sessions in the regular protocol for a total of 12 sessions. | Behavioural | FRIENDS for Life Train-the-Trainer |
| Adapted FRIENDSAlso: aFRIENDSAdapted Friends (aFRIENDS): We conducted planned adaptations to the FRIENDS protocol based on our collective experience with the protocol and qualitative data (focus group and interviews). We followed procedures developed by Lee and colleagues, including surveying service providers and trainers regarding the appropriateness of FRIENDS for the target population. Changes were made to the language (idioms, metaphors, words), cultural fit (cultural values), methods (session length, number of sessions), activities (in-session practices), which resulted in additions and substitutions in these areas while maintaining the 5 essential components of the treatment. aFRIENDS is a briefer (8-session) and more engaging and culturally-sensitive protocol than FRIENDS. | Behavioural | Adapted FRIENDS Train-the-Trainer, Adapted FRIENDS Train-the-Trainer Plus |
| Train-the-TrainerAlso: TTTrain the Trainer (TT): agency supervisors are trained to conduct effective supervision (one initial training and 2 booster sessions), and then go on to train intervention therapists. | Behavioural | Adapted FRIENDS Train-the-Trainer, FRIENDS for Life Train-the-Trainer |
| Train-the-Trainer PlusAlso: TT+Train the Trainer Plus (TT+): a modified train-the-trainer approach by which supervisors receive training plus extended on-going consultation on conducting effective supervision with intervention therapists. | Behavioural | Adapted FRIENDS Train-the-Trainer Plus |
Primary outcome
Change in Manifest Anxiety Scale for Children (MASC) from Baseline to Post Intervention completed by parents and children
Time frame: Up to 12 weeks
Effectiveness between treatment groups will be assessed by comparing the change in diagnostic status from pre to post intervention. Diagnostic status will be assessed using the Anxiety Disorders Interview Schedule for Children (ADIS-P) which includes a semi-structured interview used to determine diagnostic status and outcome. Clinical judgement is used to generate a Clinician Severity Rating (CSR). A CSR >4 is a clinical diagnosis of an anxiety disorder, CSR=3 patient at risk for developing a disorder.
1 secondary outcome
Cost Effectiveness
Time frame: Duration of Project (5 years)
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 8 Apr 2021.
- Derived from this study: PubMed 38273369Eiraldi R, Lawson GM, Glick HA, Khanna MS, Beidas R, Fishman J, Rabenau-McDonnell Q, Wilson T, Comly R, Schwartz BS, Jawad AF. Implementation fidelity, student outcomes, and cost-effectiveness of train-the-trainer strategies for Masters-level therapists in urban schools: results from a cluster randomized trial. Implement Sci. 2024 Jan 25;19(1):4. doi: 10.1186/s13012-023-01333-9.
- Derived from this study: PubMed 37790186Lawson GM, Comly R, Beidas RS, Khanna MS, Goldstein J, Brizzolara-Dove S, Wilson T, Rabenau-McDonnell Q, Eiraldi R. Therapist and supervisor perspectives about two train-the-trainer implementation strategies in schools: A qualitative study. Implement Res Pract. 2023 Aug 3;4:26334895231190854. doi: 10.1177/26334895231190854. eCollection 2023 Jan-Dec.
- Derived from this study: PubMed 27405587Eiraldi R, Khanna MS, Jawad AF, Fishman J, Glick HA, Schwartz BS, Cacia J, Wandersman A, Beidas R. A hybrid effectiveness-implementation cluster randomized trial of group CBT for anxiety in urban schools: rationale, design, and methods. Implement Sci. 2016 Jul 12;11:92. doi: 10.1186/s13012-016-0453-z.
- Individual participant dataSharing planned: No
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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.
Ricardo B Eiraldi, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRIENDS for Life, Adapted FRIENDS and Train-the-Trainer in people with Anxiety Disorders, run by Children's Hospital of Philadelphia 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 4 inclusion and 5 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 8 Apr 2021. 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 Manifest Anxiety Scale for Children (MASC) from Baseline to Post Intervention completed by parents and children (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651402, which also lists 3 linked publications.
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 8 Apr 2021.