Skip to main content
OpenTrials
Completed

NCT Number: NCT05552365

Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Developmental Language Disorder and Language Impairment Anxiety Disorders Anxiety Disorders and Symptoms Communication Disorders Language Development Disorders Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Research in Child Development, OER, NIE-NTU

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adapted Cognitive Behavioural

Behavioral

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.

Treatment as Usual

Other

Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.

Primary outcomes

  1. Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)

    Time frame: 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 outcomes

  1. Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)

    Time frame: 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.

  2. Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)

    Time frame: 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 outcomes

  1. Child Outcome and Session Rating Scales (CORS; 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

    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).

Sponsors and collaborators

Lead sponsor

Nanyang Technological University

Other

Registry information

Official study title

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

Acronym: RAP-iDLD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.