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Completed

NCT Number: NCT01761396

School-based Treatment of Anxiety Research Study (STARS)

This research is being done to compare two types of talk therapy to see which is most effective in helping school children with anxiety disorders. The investigators will compare usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered by the school mental health counselors to see if they help children with anxiety disorders to feel less scared or worried.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

About this study

This four year study involves a blocked randomized controlled trial (RCT) comparing the effectiveness of school-based CBT to usual care (UC) for approximately 375 students ages 7-17 diagnosed with an anxiety disorder. Randomization will occur at the school level and the investigators propose to conduct the study in approximately 46 schools (23 in CBT; 23 UC). Evaluations will be conducted by study staff to measure treatment progress at the end of the 12-week treatment program, at a three month follows up, and at natural termination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between the ages of 6-18 inclusively
  • meet DSM-IV criteria for a primary anxiety disorder

Exclusion criteria

  • presence of a medical or psychiatric condition contraindicating study treatment (e.g., suicidal intent)
  • need more immediate or alternative treatment
  • receiving psychosocial treatment for anxiety
  • victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision

Treatment and study plan

CBT

Behavioral

Other names: Cognitive Behavioral therapy

UC

Behavioral

Other names: Usual Care

Primary outcomes

  1. Clinical Global Impressions Improvement Scale

    Time frame: 12 weeks post-treatment

    Improvement in Clinical Anxiety Diagnosis

Secondary outcomes

  1. School Records

    Time frame: 12 weeks post-treatment

    Academic functioning

  2. Teacher Report Form

    Time frame: 12 weeks post-treatment

    classroom behavior and performance

Other outcomes

  1. Screen for Child Anxiety Related Emotional Disorders

    Time frame: 12 weeks post-treatment

    Additional measures of symptoms, mediators, and moderators

  2. Children's Automatic Thoughts Scale

    Time frame: 12 weeks post-treatment

    Cognitive distortions related to anxiety

  3. Woodcock-Johnson Tests of Achievement

    Time frame: 12 weeks post-treatment

    Academic achievement and working memory

  4. Children's Global Assessment Scale

    Time frame: 12 weeks post-treatment

    Global Functioning

  5. Brief Symptom Inventory

    Time frame: 12 weeks post-treatment

    Parental psychopathology

  6. The TCU Organizational Readiness to Change

    Time frame: 12 weeks post-treatment

    Clinician's perceptions of workplace attributes

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Johns Hopkins University
  • U.S. Department of Education

Registry information

Official study title

Modular CBT for Reducing Anxiety and Improving Educational Outcomes

Acronym: STARS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2013
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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