Developmental Language Disorder and Language ImpairmentRAP-iDLDNCT05552365
Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
A study testing Adapted Cognitive Behavioural and Treatment as Usual in people with Developmental Language Disorder and Language Impairment and Anxiety Disorders and Symptoms, run by Nanyang Technological University at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Developmental Language Disorder and Language Impairment, Anxiety Disorders and Symptoms
- What is being tested?
- Adapted Cognitive Behavioural and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Dec 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Centre for Research in Child Development, OER, NIE-NTU
Singapore
About this study
Official title: 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).
Read the 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.
- Being tested
- Adapted Cognitive Behavioural, Treatment as Usual
- Medical subject headings
- Language Development Disorders, Language Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Cognitive BehaviouralBehavioural
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 UsualOther
Participants given a mental health brochure with contact information, where they can access services provided by mental health support service providers.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | 8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder. Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: 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
Measured: Administered at post treatment which is a maximum of 4 weeks from final session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start16 Dec 2022
- Primary completion14 May 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language Disorder and Language ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Goh Kok Yew, Nanyang Technological University
- Investigators
- Shaun KY Goh, PhD, Principal investigator, NTU-NIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552365
- Sponsor's protocol ID
- RP 2/21 SG (2021-T1-001-011)
- Acronym
- RAP-iDLD
- Status last verified
- Dec 2024
- First submitted
- 15 Sep 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT05552365
- Acronym / sponsor ID
- RAP-iDLD / RP 2/21 SG (2021-T1-001-011)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Behavioral: Adapted Cognitive Behavioural8-session cognitive behavioural intervention adapted for children indicated to have developmental language disorder. |
| Treatment as Usual | Other | Other: Treatment as UsualParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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]
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Cognitive Behavioural8-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. | Behavioural | Active Intervention |
| Treatment as UsualParticipants given a mental health brochure with contact information, where they can access services provided by mental health support service providers. | Other | Treatment as Usual |
Primary outcome
Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
Time frame: Administered at post treatment which is a maximum of 4 weeks from final session
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
2 secondary outcomes
Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)
Time frame: Administered at post treatment which is a maximum of 4 weeks from final session
Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)
Time frame: Administered at post treatment which is a maximum of 4 weeks from final session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Project DescriptionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun KY Goh, PhD principal investigator
NTU-NIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Cognitive Behavioural and Treatment as Usual in people with Developmental Language Disorder and Language Impairment and Anxiety Disorders and Symptoms, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004) (time frame: Administered at post treatment which is a maximum of 4 weeks from final session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.