Treatment of School Refusal

A randomised clinical trial of the augmentation of cognitive behavioural therapy with fluoxetine for school refusing youth who have an anxiety disorder by assessing school attendance

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000103561

Enrollment

150

Registered

2006-03-17

Start date

2006-03-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to determine if combined cognitive behaviour therapy (CBT) and antidepressant medication (fluoxetine) treatment of school refusing children (11-16.5 years) improves their response to treatment and longer term outcome, compared to CBT only group. In order to determine that this predicted improvement in outcome is due to the active effects of medication rather than expectancy effects associated with taking a pill, a third group comprising CBT + placebo treatment will be included.

Interventions

1) Individual Cognitive Behavioural Therapy, 15 sessions over 22 weeks for young person and parent(s) 2) Individual Cognitive Behavioural Therapy, 15 sessions over 22 weeks for young person and parent(s) plus Fluoxetine 10-20mg (pre-pubescent Tanner stage 1) or 10-60mg (pubescent Tanner stage 2+) over 22 weeks for the young person. Fluoxetine/placebo is in capsule form.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

11 Years to 16 Years

Healthy volunteers

Inclusion criteria

Less than 50% school attendance for the past four school weeks, with the young person being at home with parental knowledge and DSM-IV anxiety disorder.

Exclusion criteria

Current physical illness that precludes school attendance, current treatment with anti-depressant or other psychotropic medication, pregnancy, intellectual disability that prevents CBT, insufficient English language skill that precludes CBT, current inpatient admission (e.g., for suicide risk), primary behaviour disorders (e.g., conduct disorder), bipolar disorder, psychosis, primary diagnosis of substance abuse disorder.

Outcome results