Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder (RAP-iDLD)

Nanyang Technological University

Status: Completed

Conditions: Anxiety Disorders and Symptoms; Developmental Language Disorder and Language Impairment

Treatments: Behavioral: Adapted Cognitive Behavioural; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05552365

RP 2/21 SG (2021-T1-001-011)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Active Intervention

Experimental group

Description:

8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder.

Treatment:

Behavioral: Adapted Cognitive Behavioural

Treatment as Usual

Other group

Description:

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.

Treatment:

Other: Treatment as Usual