ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000351819

Ethics application status

Approved

Date submitted

23/03/2012

Date registered

27/03/2012

Date last updated

29/03/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

An Evaluation of Stepped Care for Child Anxiety

Scientific title

A Randomised Controlled Trial of Standard Care versus Stepped Care for Children and Adolescents with Anxiety Disorders

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1129-3972

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Stepped Care: consist of 3 treatment steps. Participants and their parents in this condition will first receive the least intensive intervention followed by more intensive interventions if required. Step 1 will involve completion of the validated self-help program Helping your Anxious Child (primary school participants) or Cool Teens (high school participants). The program will be available in both online and workbook formats and consists of 10 modules each taking 30-90 minutes to complete. A period of 12 weeks is allocated for completion of the self-help program during which time families will receive 4, 30 minute contacts with a CBT therapist (by telephone or email self-selected by families). Based on our previous work, scheduled sessions will involve checking of progress, motivational prompts, and assistance with difficulties Therapists will also be available for client-initiated contact between sessions. Step 2 will involve the same program and treatment length as offered in standard care. Step 3 will involve an intensive intervention for treatment non-responders. This is a 12x 50 minute session individual program, held weekly over a 12 week period, for children/adolescents and their primary caregiver with content based on a functional assessment of barriers and limitations to the previous treatment. It continues skills from the Cool Kids program in a more intensive fashion, incorporates motivational features and has a strong focus on parenting factors and parent-child interaction. Sessions in step 3 are conducted by clinical psychologists or clinical psychology interns.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Standard Care: 10x 50 minute individual sessions attended by the child/adolescent and their primary caregiver over a 12 week period. Treatment is implemented by psychologists, clinical psychologists and psychology interns using the manualised Cool Kids Anxiety Management Program.

Control group

Active

Outcomes

Primary outcome [1]

Changes in diagnostic status and severity according to the Anxiety Disorders Interview Schedule

Timepoint [1]

Pre treatment compared to one year after randomisation

Secondary outcome [1]

Changes on self and primary caregiver report measure:
Spence Children's Anxiety Scale

Timepoint [1]