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

Primary Purpose

Developmental Language Disorder and Language Impairment, Anxiety Disorders and Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Adapted Cognitive Behavioural
Treatment as Usual
Sponsored by
Nanyang Technological University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Developmental Language Disorder and Language Impairment

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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).

Sites / Locations

  • Centre for Research in Child Development, OER, NIE-NTURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Active Intervention

Treatment as Usual

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)
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.
Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)
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

Full Information

First Posted
September 15, 2022
Last Updated
March 21, 2023
Sponsor
Nanyang Technological University
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1. Study Identification

Unique Protocol Identification Number
NCT05552365
Brief Title
Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
Acronym
RAP-iDLD
Official Title
Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanyang Technological University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder and Language Impairment, Anxiety Disorders and Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Intervention
Arm Type
Experimental
Arm Description
8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder.
Arm Title
Treatment as Usual
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Cognitive Behavioural
Intervention Description
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
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
Description
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
Time Frame
Administered at post treatment which is a maximum of 4 weeks from final session
Secondary Outcome Measure Information:
Title
Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)
Description
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.
Time Frame
Administered at post treatment which is a maximum of 4 weeks from final session
Title
Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)
Description
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
Time Frame
Administered at post treatment which is a maximum of 4 weeks from final session
Other Pre-specified Outcome Measures:
Title
Child Outcome and Session Rating Scales (CORS; Duncan et al., 2003)
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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] 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hillary Lim, Bsc
Phone
88190744
Email
rap.idld@nie.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun KY Goh, PhD
Organizational Affiliation
NTU-NIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Research in Child Development, OER, NIE-NTU
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hillary Lim
Phone
88190744

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://nie.edu.sg/research/projects/project/rp-2-21-sg-(2021-t1-001-011)
Description
Project Description

Learn more about this trial

Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

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