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Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

NCT ID: NCT05552365

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Developmental Language Disorder and Language Impairment Anxiety Disorders and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Active Intervention

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

Group Type EXPERIMENTAL

Adapted Cognitive Behavioural

Intervention Type 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

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.

Group Type OTHER

Treatment as Usual

Intervention Type OTHER

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

Interventions

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Adapted Cognitive Behavioural

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.

Intervention Type BEHAVIORAL

Treatment as Usual

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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Shaun Goh Kok Yew

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaun KY Goh, PhD

Role: PRINCIPAL_INVESTIGATOR

NTU-NIE

Locations

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

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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https://nie.edu.sg/research/projects/project/rp-2-21-sg-(2021-t1-001-011)

Project Description

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id