Clinical trial NCT05552365: Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
Official title: Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Language Disorder and Language Impairment
Anxiety Disorders and Symptoms
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 \[Either one of the following\]

  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).

Primary outcomes:
measure: Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
timeFrame: Administered at post treatment which is a maximum of 4 weeks from final session
Secondary outcomes:
measure: Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)
timeFrame: Administered at post treatment which is a maximum of 4 weeks from final session
measure: Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)
timeFrame: Administered at post treatment which is a maximum of 4 weeks from final session
Other outcomes:
measure: Child Outcome and Session Rating Scales (CORS; Duncan et al., 2003)
timeFrame: At the end of each of the 8-sessions (each session is expected to run for 60 - 90 mins) for the active intervention
Locations:
city: Singapore
country: Singapore
facility: Centre for Research in Child Development, OER, NIE-NTU
Study officials:
affiliation: NTU-NIE
name: Shaun KY Goh, PhD
role: PRINCIPAL_INVESTIGATOR
References: