Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder

Anxiety Disorders and Symptoms Clinical Trial

— RAP-iDLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552365
• Other study ID #: RP 2/21 SG (2021-T1-001-011)
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2023
• Source: Nanyang Technological University
• Contact: Hillary Lim, Bsc
• Phone: 88190744
• Email: rap.idld[@]nie.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Disease
• Language Development Disorders
• Language Disorders

Intervention

Behavioral:
• 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.

Other:
• Treatment as Usual
Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.

Locations

Country	Name	City	State
Singapore	Centre for Research in Child Development, OER, NIE-NTU	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Outcome and Session Rating Scales (CORS; Duncan et al., 2003)	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).	At the end of each of the 8-sessions (each session is expected to run for 60 - 90 mins) for the active intervention
Primary	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	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.	Administered at post treatment which is a maximum of 4 weeks from final session
Secondary	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	Administered at post treatment which is a maximum of 4 weeks from final session

External Links

•   Project Description