Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

NCT05552365 | Completed

• 1 other identifier: RP 2/21 SG (2021-T1-001-011)
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Developmental Language Disorder and Language Impairment; Anxiety Disorders and Symptoms

Outcome Measures

Primary Outcomes (1)

• 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

  Administered at post treatment which is a maximum of 4 weeks from final session

Secondary Outcomes (2)

• 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

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

  Administered at post treatment which is a maximum of 4 weeks from final session

Other Outcomes (1)

• 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

Study Arms (2)

Active Intervention

EXPERIMENTAL

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

Behavioral: Adapted Cognitive Behavioural

Treatment as Usual

OTHER

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

Interventions

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.

Active Intervention

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.

Treatment as Usual

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanyang Technological University: lead

Study Sites (1)

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

Singapore, Singapore

Location

Related Links

• Project Description

MeSH Terms

Conditions

Language Development Disorders; Language Disorders; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Shaun KY Goh, PhD

  NTU-NIE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 23, 2022
• Study Start: December 16, 2022
• Primary Completion: May 14, 2024
• Study Completion: October 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

SG (1)