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Clinical Trials/ACTRN12624000456550
ACTRN12624000456550
Not yet recruiting
未知

A Randomised Controlled Trial of the Efficacy of Internet-Based Cognitive Behaviour Therapy plus messaging support for managing child and adolescent anxiety in regional communities

niversity of Southern Queensland0 sites150 target enrollmentApril 15, 2024

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Southern Queensland
Enrollment
150
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 15, 2024
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Southern Queensland

Eligibility Criteria

Inclusion Criteria

  • Children and adolescents will be invited to participate in the study if they meet the following criteria at initial registration for the Momentum platform;
  • (1\) if they present with elevated levels of anxiety on the Spence Children’s Anxiety Scale (equal or greater than 84th percentile or T\-score of 60\);
  • (2\) are residents of regional/rural areas (as classified by areas 2\-7 of the Modified Monash Model, identified via postcode);
  • (3\) do not demonstrate clinically interfering depression levels on the Centre for Epidemiological Studies Depression Scale for Children. Clinically interfering levels are defined as meeting the 'elevated' cut\-off on this scale AND rating the degree of interference from the depression at a minimum of 5 or higher on an 8\-point scale;
  • (4\) have access to the Momentum online platform via a computer or mobile device with an Australian IP address;
  • (5\) aged 7\-17 years;
  • Additional inclusion criteria (ascertained via interview):
  • (1\) a primary diagnosis of social anxiety disorder (SAD), generalised anxiety disorder (GAD), separation anxiety (SEP), or specific phobia (SP) on the Anxiety Disorders Interview Schedule for Children – Child and Parent version (ADIS\-C/P; Silverman and Albano, 1996\);
  • (2\) willingness to be randomised to one of the two conditions.
  • Children and adolescents with a primary diagnosis of obsessive\-compulsive disorder (OCD), posttraumatic disorder (PTSD) or panic disorder (PD) will not be eligible for participation. However, these diagnoses will be permitted if secondary. Participants with secondary mood disorders will be included, provided that their mood disturbance had a clinician severity rating (CSR) of \<5 on the ADIS\-C/P.

Exclusion Criteria

  • Children and adolescents with current suicidal ideation, self\-harm tendencies, substance abuse issues, significant behavioural disorders, pervasive developmental disorders, learning disorders, or those currently receiving professional help, as well as those who initiated or altered medication for anxiety or sleep within the six weeks leading up to the baseline assessment, will be excluded from the study.

Outcomes

Primary Outcomes

Not specified

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