NCT05552365

Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Nanyang Technological University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Developmental Language Disorder and Language Impairment
• Anxiety Disorders and Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Adapted Cognitive Behavioural	8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder. Intervention includes psychoeducative, bodily relaxation, graded exposure, cognitive restructuring and brainstorming. Adaptations include increasing the number of visual supports, use of physical objects to illustrate concepts in addition to language.
OTHER	Treatment as Usual	Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.

Timeline

• Start date: 2022-12-16
• Primary completion: 2024-05-14
• Completion: 2024-10-31
• First posted: 2022-09-23
• Last updated: 2024-12-04

Locations

1 site across 1 country: Singapore