Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Developmental Language Disorder and Language Impairment, Anxiety Disorders and Symptoms

Intervention / Treatment
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* Behavioral: Adapted Cognitive Behavioural
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Intervention<br>8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder. | Behavioral: Adapted Cognitive Behavioural<br>* 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.<br>|
| Other: Treatment as Usual<br>Participants are re-directed to mental health support services. All participants given a mental health brochure which has contact details of mental health services for children. | Other: Treatment as Usual<br>* Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004) | 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 | Administered at post treatment which is a maximum of 4 weeks from final session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999) | The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder. The child report scores (41 items) and parent report scores (41 items) of the SCARED will be utilised here. | Administered at post treatment which is a maximum of 4 weeks from final session | 
| Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013) | CALIS is a 2-part scale that measures child's anxiety life interference from both the child's and parent's perspectives. The children scale is a 10-item self-reported questionnaire on questionnaire evaluating the interference to the child's life and to the parent's life. All the items are related to common daily activities. The items are rated on a 5-point Likert scale (0 = Not at all, 1 = Only a little, 2 = Sometimes, 3 = Quite a lot, 4 = A great deal), where the higher scores indicate high levels of interference. Scores from the child and parent version will be used here | Administered at post treatment which is a maximum of 4 weeks from final session |