Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Developmental Language Disorder and Language Impairment
- Sponsor
- Nanyang Technological University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Shaun Goh Kok Yew
Lecturer
Nanyang Technological University
Eligibility Criteria
Inclusion Criteria
- •Shows signs of elevated anxiety, fear or stress, as rated on anxiety measures conducted by this study
- •Enrolled in Primary 1 to 6 in a Ministry of Education Primary School
- •Signs of a language difficulty \[Either one of the following\]
- •Existing clinical opinion/report of this when child \>5 years old
- •Score \<10th percentile on language measures conducted by this study
Exclusion Criteria
- •Conditions which exclude Developmental Language Disorder (e.g. Autism, Intellectual Disability, Hearing Impairment, other biomedical conditions).
- •Non-anxiety disorder as primary mental health disorder
- •Currently receiving treatment for anxiety disorder (e.g. pharmacotherapy or psychotherapy).
Outcomes
Primary Outcomes
Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
Time Frame: Administered at post treatment which is a maximum of 4 weeks from final session
The ADIS-IV is a semi-structured interview organised diagnostically to permit differential diagnoses of anxiety disorders. Its yields a severity rating (0 to 8) which is utilised here as the primary outcome
Secondary Outcomes
- Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)(Administered at post treatment which is a maximum of 4 weeks from final session)
- Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)(Administered at post treatment which is a maximum of 4 weeks from final session)