Anxiety DisordersNCT03044678
School Based Prevention for Childhood Anxiety
A study testing REACH for Success and Self-Study in people with Anxiety Disorders, run by Arizona State University.
Trial summary
This study was designed to conceptualize a school-based prevention program or childhood anxiety. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- REACH for Success and Self-Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jan 2015
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Borderline child anxiety levels based on the Spence Child Anxiety Scale
Who cannot join
- Externalizing problems (based on teacher nominations) more severe than Spence Child Anxiety Scale borderline levels
About this study
This study was designed to conceptualize a school-based prevention program or childhood anxiety.
Read the detailed description
This is a project corresponding to a career development grant. The main goal of the proposed research was to identify potential barriers to implementing a school-based anxiety preventive intervention, identify strategies to overcome these barriers, and use this information to test a school-based indicated intervention for child anxiety.
- Conditions
- Anxiety Disorders
- Being tested
- REACH for Success, Self-Study
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH for SuccessBehavioural
Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)
Self-StudyBehavioural
Books for youth about anxiety management
| Study group | Role | What they receive |
|---|---|---|
| Experimental: REACH for Success | Experimental | Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each Receives: Behavioral: REACH for Success |
| Active Comparator: Self-study | Active comparator | Active Comparator: Books "What to do when you are scared and worried?How to do homework without throwing-up? How to get organized without losing it?" Reading at home Receives: Behavioral: Self-Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child anxiety symptoms (clinical)
Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children
Measured: Change from baseline to 12-month follow-up
Change in child anxiety levels (typical)
Child anxiety based on the Spence Child Anxiety Scale
Measured: Change from baseline to 12-month follow-up
Secondary outcomes (10)
Changes in child negative cognition
Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
Measured: Change from baseline to immediate posttest (at 6-weeks)
Changes in child negative cognition
Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire
Measured: Change from baseline to 12-month follow-up
Changes in emotion understanding and expression
Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
Measured: Change from baseline to immediate posttest (at 6-weeks)
Changes in emotion understanding and expression
Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children
Measured: Change from baseline to 12-month follow-up)
Changes in self efficacy
Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
Measured: Change from baseline to immediate posttest (at 6-weeks)
Changes in self efficacy
Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations
Measured: Change from baseline to 12-month follow-up)
Changes in child social skills
Child social skills based on the Social Skills Improvement Rating System
Measured: Change from baseline to immediate posttest (at 6-weeks)
Changes in child social skills
Child social skills based on the Social Skills Improvement Rating System
Measured: Change from baseline to 12-month follow-up)
Changes in somatic arousal
Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Measured: Change from baseline to immediate posttest (at 6-weeks)
Changes in somatic arousal
Child somatic arousal based on the Physiological Hyperarousal Scale for Children
Measured: Change from baseline to 12-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Jan 2010
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
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.
- More trials run by Arizona State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Pina, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044678
- Sponsor's protocol ID
- MH086687
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Based Prevention for Childhood Anxiety
- ClinicalTrials.gov ID
- NCT03044678
- Acronym / sponsor ID
- MH086687
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 7 Feb 2017 (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 was designed to conceptualize a school-based prevention program or childhood anxiety.
Detailed description
This is a project corresponding to a career development grant. The main goal of the proposed research was to identify potential barriers to implementing a school-based anxiety preventive intervention, identify strategies to overcome these barriers, and use this information to test a school-based indicated intervention for child anxiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: REACH for Success | Experimental | Behavioral: REACH for SuccessExperimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each |
| Active Comparator: Self-study | Active comparator | Behavioral: Self-StudyActive Comparator: Books "What to do when you are scared and worried?How to do homework without throwing-up? How to get organized without losing it?" Reading at home |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Borderline child anxiety levels based on the Spence Child Anxiety Scale
Key exclusion criteria (1 listed)
- Externalizing problems (based on teacher nominations) more severe than Spence Child Anxiety Scale borderline levels
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 |
|---|---|---|
| REACH for SuccessExposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness) | Behavioural | Experimental: REACH for Success |
| Self-StudyBooks for youth about anxiety management | Behavioural | Active Comparator: Self-study |
Primary outcome
Change in child anxiety symptoms (clinical)
Time frame: Change from baseline to 12-month follow-up
Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children
Change in child anxiety levels (typical)
Time frame: Change from baseline to 12-month follow-up
Child anxiety based on the Spence Child Anxiety Scale
10 secondary outcomes
Changes in child negative cognition
Time frame: Change from baseline to immediate posttest (at 6-weeks)
Changes in child negative cognition
Time frame: Change from baseline to 12-month follow-up
Changes in emotion understanding and expression
Time frame: Change from baseline to immediate posttest (at 6-weeks)
Changes in emotion understanding and expression
Time frame: Change from baseline to 12-month follow-up)
Changes in self efficacy
Time frame: Change from baseline to immediate posttest (at 6-weeks)
Changes in self efficacy
Time frame: Change from baseline to 12-month follow-up)
Changes in child social skills
Time frame: Change from baseline to immediate posttest (at 6-weeks)
Changes in child social skills
Time frame: Change from baseline to 12-month follow-up)
Changes in somatic arousal
Time frame: Change from baseline to immediate posttest (at 6-weeks)
Changes in somatic arousal
Time frame: Change from baseline to 12-month follow-up)
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 Feb 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing REACH for Success and Self-Study in people with Anxiety Disorders, run by Arizona State University.
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 1 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 child anxiety symptoms (clinical) (time frame: Change from baseline to 12-month follow-up). 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 Feb 2017.