Anxiety Disorders and Symptoms Clinical Trial
Official title:
Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
This study aims to pilot a world-first intervention, a mental health intervention augmented for children indicated with developmental language disorder (DLD). It serves as a proof-of-concept of how existing observational studies on these topics at the Centre for Research in Child Development (c.f. Tran-Sen; Gibber) can be translated into interventions. Mental health problems here are defined as anxiety type problems of social anxiety, specific phobia, separation anxiety and generalised anxiety. DLD is defined as a marked difficulty in oral language in the absence of biomedical causes (Bishop et al., 2017). This randomised pilot answers three uncertainties in preparation for a future definitive randomised control trial (RCT).
This pilot aims to answer three uncertainties for a future randomised control trial (RCT), namely (1) Is the proposed intervention's efficacy sufficient (2) Are the proposed methods of recruitment sufficient (3) Are the proposed measures of evaluation sufficient Hypotheses: (1) Piloted intervention is sufficient for definitive RCT as 90% confidence intervals contain expected improvement versus treatment-as-usual (2) Piloted recruitment methods are sufficient for definitive RCT as recruitment rate is >4/month, dropout rate<25%. (3) Piloted measures are sufficient for definitive RCT as rates of unusable data are <20% and reliability alpha >.70. ;
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