Randomised Pilot Control Trial for Reducing Anxiety Problems among Children indicated to have Developmental Language Disorder (RAP-iDLD)
Thank you for showing interest to the Randomised Pilot Control Trial for Reducing Anxiety Problems among Children indicated to have Developmental Language Disorder (RAP-iDLD) study!
Please read the following information sheet to understand our study better. If you think your child falls under the criteria and you are interested in participating in the study, please indicate your interest in the following page. We will contact you again if your child is suitable for our study, to schedule you for a screening session at the Centre for Research in Child Development located within National Institute of Education (NIE) or at your desired location.
The following survey will take around 5 - 10 mins to complete. Should you have any questions, feel free to contact the team at rap.idld@nie.edu.sg or WhatsApp us at 8819 0744.
Principal Investigator: Dr Shaun Goh shaun.goh@nie.edu.sg
1. Study Information
IRB Reference Number: IRB-2021-895
Title: Randomised Pilot Control Trial for Reducing Anxiety Problems among Children indicated to have Developmental Language Disorder (RAP-iDLD)
2. Purpose of the Research Study
You and your child were selected to participate in this study because you responded to our recruitment efforts. Your child has shown an indication of having a developmental language disorder, and elevated levels of anxiety that impair daily functioning.
The purpose of this pilot study is to finalise a world-first intervention, a mental health intervention augmented specially for children indicated with developmental language disorder (DLD), such as yours. This intervention will be delivered by a qualified mental health professional (i.e. PI Dr Shaun Goh, PhD Clinical Psychology, Registered in Singapore and Australia) and is based on existing research. But before testing this intervention in a larger study designed to definitively examine the effectiveness of the intervention, we first need to trial the implementation of this intervention to ensure that it is as interesting and (age) appropriate as possible. Because mental health can be an abstract concept that can be ‘wordy’, we are interested to find out if the augmentations to the intervention here result in higher accessibility and suitability for children with DLD. We are also interested to know if the methods and measures we employ are robust for understanding mental health among DLD children.
This pilot study will test up to 42 primary school aged children and their caregivers before and after the intervention. This pilot study will occur from April 2022 to October 2023. It is anticipated that participants will be recruited by providing advertisement material to various sources where possible (e.g. community, clinics, schools, publicly accessible social media).
3. Inclusion/Exclusion Criteria
This study will be undertaken with children who meet the following criteria:
(1) In Primary 1 to 6 in a MOE Primary School
(2) Signs of a language difficulty [Either one of the following]
(a) Existing clinical opinion/report of this when child >5 years old
(b) Score <10th percentile on language measures conducted by this study
(3) Child shows signs of elevated anxiety, fear or stress
(a) As rated on anxiety measures conducted by this study
In addition, those who meet the following criteria are ineligible for this study:
(1) Conditions which exclude Developmental Language Disorder (e.g. Autism, Intellectual Disability, Hearing Impairment, other biomedical conditions).
(2) Non-anxiety disorder as primary mental health disorder
(3) Currently receiving treatment for anxiety disorder (e.g. pharmacotherapy or psychotherapy).
4. What Procedures will be Followed in this Study?
If you take part in this study, you and your child will be invited to 10 sessions as follows
a External site refers to a MOE school or clinic where your child is currently accessing support, if prior approval is obtained. Or at your home, which needs a quiet room with a table to properly conduct child activities.
(1) Session 1 involves questionnaires/interviews and game-like activities
- We will ask you to fill out questionnaires and/or interviews that examine child development, well-being, mental health, environmental and caregiving backgrounds, language, and the socio-emotional needs of you and your child. Some questions may be sensitive in nature and, as with all questions; you may choose not to answer.
- During the game-like tasks, we will ask your child to participate in game-like activities. The games in these sessions will help us to understand your child’s language and abstract thinking ability. We may also ask your child to play with and look at toys, books, novel objects, or pictures
- We will video and audio record you and your child so that we will be able to study language and its relation with mental health.
(2) Sessions 2 to 9 involves skills building activities with video and audio-recording
- During these skills building activities between a clinically trained Psychologist and your child, we will ask your child to participate in these skills building activities to overcome his or her anxiety. Your child may be asked to play with and look at toys, books, worksheets, novel objects, or pictures. We may also invite you to participate alongside your child for 5 to 10 minutes, and to practice these skills at home between sessions.
- During some of these sessions you and your child will be asked to choose a series of activities to be exposed to, which are designed to gradually increase your child’s ability to overcome his or her fears. Because of this, your child may face potential distress. At any point in time, if you or your child gets unduly distressed, the clinical psychologist may take the decision to terminate these exposures. Alternatively, as with all of our measures, if you are uncomfortable with these exposures, you may opt not to participate in that portion of the session by alerting the staff.
- These sessions are entirely optional for Group B.
- We will video and audio record your child so that we will be able to subsequently examine language and their relation with mental health.
(3) Session 10 involves questionnaires/interviews and game-like activities with audio recording.
- We will ask you to fill out questionnaires and/or interviews that examine child development, well-being, mental health, environmental and caregiving backgrounds, language, and the socio-emotional needs of you and your child. Some questions may be sensitive in nature and, as with all questions; you may choose not to answer.
- During the game-like tasks, we will ask your child to participate in game-like activities. The games in these sessions will help us to understand your child’s language and abstract thinking ability. We may also ask your child to play with and look at toys, books, novel objects, or pictures.
- We will audio record you and your child so that we will be able to study language and its relation with mental health.
(4) Be randomized to Group A or Group B. Randomization means assigning you to one of these two groups by chance, like tossing a coin or rolling dice.
(5) Your participation in the study will last from 5 weeks, up to a maximum of 4 1/2 months, as it depends on how many sessions you choose to complete per week. A maximum of 2 sessions can be completed per week. A maximum of 1 month can pass from Session 1 to 2, and from Session 9 to 10.
(6) Finally, we will ask you for any feedback you have about the visit and ways to make it more engaging for participants. In some sessions, we may take some photographs of you and your child, which will be used for research purposes. If you wish, we will also provide you with some pictures as souvenirs.
5. Incidental Findings:
“Incidental findings” are findings that have potential health, or mental health implications, to participant like you and/or your child and are discovered in the course of conducting the study, but are unrelated to the purposes, objectives or variables of the study. These findings may cause you to feel anxious and may affect your and/or your child’s current or future life and/or health insurance coverage. You will be asked to indicate whether you wish to be re-identified and notified in the event of an important incidental finding that is related to you and/or your child.
If you agree to be re-identified and notified, we will explain the incidental finding to you and discuss and advise you on the next steps to follow. You may wish to do more tests and seek advice to confirm this incidental finding. The costs for any care that will be needed to diagnose or treat an incidental finding would not be paid for by this research study. These costs would be your responsibility.
Confidentiality of Data
Your participation in this study will involve the collection of Personal Data. Personal Data collected for this study will be kept confidential. Your data will be stored for a minimum of 10 years in a secure environment within NTU. Your data, to the extent of the applicable laws and regulations, will not be made publicly available. Access to source data/documents will be restricted to those in the Study Designation Log. Agreement confirming confidentiality of data handling will be signed by every member of the project team, including local and/or international collaborators as well as the service providers (e.g., transcribing companies and consultants) who have full or partial access to the research data. Co-PIs and/or collaborators will be allowed access to the data for subsequent analyses. The investigator(s)/institution(s) will permit study-related monitoring, audits and/or IRB review and regulatory inspection(s), providing direct access to source data/document and/or as required under Singapore laws. Your data may be shared with government bodies when acquisitioned by law or when ordered to do so by a court or legislations.
By signing the Consent Form, you consent to (i) the collection, access to, use and storage of your Personal Data by National Institute of Education, (ii) the disclosure of such Personal Data to our authorised service providers and relevant third parties, and (iii) to the sharing of such data amongst both locally and internationally based study team members. “Personal Data” means data about you which makes you identifiable (i) from such data or (ii) from that data and other information which an organisation has or likely to have access. Examples of personal data include medical conditions, medications, investigations, treatment history, and audio recordings. Data collected are the property of NTU-NIE. In the event of any publication regarding this study, only aggregated research data without identifiable personal details will be used, and your identity will remain confidential.
Anonymised data will be archived for possible secondary use by local and international researchers in child development; your personal identifiers will not be included in such “anonymized” shared data. Research arising in the future, based on this “Personal Data”, will be subject to review by the relevant institutional review board. Data collected and entered into the Case Report Form(s), Data Collection Form(s), Interviews(s) and Questionnaire(s) are the property of National Institute of Education. In the event of any publication regarding this study, your identity will remain confidential.