Anxiety Disorders and Symptoms, Developmental Language Disorder and Language Impairment
Conditions
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.
Interventions
BEHAVIORALAdapted 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.
OTHERTreatment as Usual
Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.
Sponsors
Nanyang Technological University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical interview (ADIS) will be administered by assessors who will not be told which arm participants are. Participants will be told not to mention intervention arm status to assessors.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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 \[Either one of the following\] 1. Existing clinical opinion/report of this when child \>5 years old 2. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013) | Administered at post treatment which is a maximum of 4 weeks from final session | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Child Outcome and Session Rating Scales (CORS; Duncan et al., 2003) | At the end of each of the 8-sessions (each session is expected to run for 60 - 90 mins) for the active intervention | The CORS is targeted for children aged 6 to 12 and has the same format as the Outcome Rating Scales (Duncan et al.,2003). It is written in a child-friendly language, where the child uses the happy and sad faces to understand the scale (Duncan et al., 2003). |
Countries
Singapore
Outcome results
None listed