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

Randomised Pilot Control Trial for 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).

Study Overview

• Status: Recruiting
• Conditions: Developmental Language Disorder and Language Impairment; Anxiety Disorders and Symptoms
• Intervention / Treatment: Behavioral: Adapted Cognitive Behavioural; Other: Treatment as Usual

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hillary Lim, Bsc; Phone Number: 88190744; Email: rap.idld@nie.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Centre for Research in Child Development, OER, NIE-NTU
    • Contact: Hillary Lim; Phone Number: 88190744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Intervention; 8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder.	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 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; Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanyang Technological University
• Investigators: Principal Investigator: Shaun KY Goh, PhD, NTU-NIE

Publications and helpful links

Helpful Links

• Project Description

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Disease; Anxiety Disorders; Language Disorders; Language Development Disorders
• Other Study ID Numbers: RP 2/21 SG (2021-T1-001-011)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No