An interventional study of Adapted Cognitive Behavioural and Treatment as Usual in Developmental Language Disorder and Language Impairment and Anxiety Disorders and Symptoms, sponsored by Nanyang Technological University. Completed at 1 site in Singapore. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Nanyang Technological University · Not applicable, Interventional, and Prevention
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.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's enrollment of 9 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →Nanyang Technological University is the lead sponsor of 52 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signs of a language difficulty [Either one of the following]
Exclusion Criteria:
8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder.
Behavioral: Adapted Cognitive Behavioural
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
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.
Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.
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
Time frame: Administered at post treatment which is a maximum of 4 weeks from final session
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.
Time frame: 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
Time frame: Administered at post treatment which is a maximum of 4 weeks from final session
Child Outcome and Session Rating Scales (CORS; Duncan et al., 2003)
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).
Time frame: At the end of each of the 8-sessions (each session is expected to run for 60 - 90 mins) for the active intervention
Plan to share: Undecided
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Language Development Disorders →
Nanyang Technological University