Parent of Child With Chronic Life-threatening IllnessNeW-INCT03684382
Narrative E-Writing Intervention (NeW-I) for Parents of Children With Chronic Life-Threatening Illness
A study testing NeW-I group in people with Parent of Child With Chronic Life-threatening Illness, run by Nanyang Technological University at 4 sites in Singapore.
Trial summary
Narrative e-Writing Intervention (NeW-I) is an evidence-based, strength-focused and meaning-oriented approach that aims at enhancing well-being, alleviating burden, and reducing adverse grief outcomes among Singaporean parents caring for a child with chronic life-threatening illness. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent of Child With Chronic Life-threatening Illness
- What is being tested?
- NeW-I group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesSingapore
- Study dates
- 1 Feb 2019to Oct 2020
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mother or father whose child has been diagnosed with a chronic life-threatening illness between the ages of 0-19 years, with a prognosis of more than 3 months since time of study participation so as to ensure successfully completion of all intervention components before child's death.
- Able to speak, read and write in English, as well as to provide informed consent.
Who cannot join
- Cannot provide informed consent
- Suffering from severely high levels of depressive symptoms, anxiety and psychological distress (i. e. score of 19 or higher on Patient Health Questionnaire-9 (PHQ-9) or score of 29 or higher on Kessler Psychological Distress Scale (K-10))
Trial locations and contacts
4 sites in 1 country.
Singapore4 sites, 4 recruiting
- Recruiting
Club Rainbow Singapore
Singapore, 050538
Sashikumar Ganapathy, +65 91997314, sashi@clubrainbow.org
- Not yet recruiting
KK Women's and Children's Hospital
Singapore, 229899
Lee Beng Ang, +65 63941634, ang.lee.bengl@kkh.com.sg
- Recruiting
Muscular Dystrophy Association Singapore
Singapore, 579837
Sherena Loh, +65 62596933, sherena_loh@mdas.org.sg
- Recruiting
Rare Disorders Society Singapore
Singapore, 587973
Kenneth Mah, +65 64022898, kenneth@rdss.org.sg
About this study
Official title: Development and Evaluation of a Narrative E-Writing Intervention (NeW-I) for Parents of Children With Chronic Life-Threatening Illness
Narrative e-Writing Intervention (NeW-I) is an evidence-based, strength-focused and meaning-oriented approach that aims at enhancing well-being, alleviating burden, and reducing adverse grief outcomes among Singaporean parents caring for a child with chronic life-threatening illness. In collaboration with KK Women's and Children's Hospital and Club Rainbow Singapore, a pilot randomized controlled trial with a built-in qualitative evaluation and feasibility study will be carried out to assess the efficacy of the therapist-facilitated NeW-I protocol and platform among a purposive sample of 66 participants. The findings generated will form the foundation for a full-scale RCT for advancing paediatric palliative care and parental bereavement support.
Read the detailed description
Background: Conventional grief support interventions for parents whose children are suffering from a chronic life-threatening illness often begin only after the child's death. Despite robust evidence which shows that pre-loss interventions that enhance death preparedness can alleviate psychological distress and prevent adverse grief outcomes among family caregivers of dying patients, there is no known program designed specifically to address the psycho-emotional-spiritual needs of parents facing child loss. And while the National Strategy for Palliative Care in Singapore aims to promote holistic end-of- life care services to patients and their caregivers, vast inadequacy continues to exist in the support provided to parents caring for a dying child in the local context.
Objective and Methods: A novel therapist-facilitated, online intervention is conceived to fill this critical service gap. Adopting an evidence-based approach, the research team has developed a strength-focused and meaning-oriented Narrative e-Writing Intervention (NeW-I) for parents anticipating the death of their child due to a chronic life-threatening condition. The design of NeW-I is informed by an existing body of research (i.e. international systematic review and local qualitative inquiry) that critically examines the lived experience of bereaved parents of children with life- limiting illnesses. NeW-I will be implemented in Singapore in collaboration with KK Women and Child's Hospital and Club Rainbow Singapore. A pilot Randomized Control Trial (RCT) with a built-in accessibility and feasibility study will examine the efficacy of the NeW-I therapeutic protocol for enhancing quality of life, spiritual wellbeing, hope and perceived social support, as well as reducing depressive symptoms, caregiver burden and anticipatory grief among a purposive sample of 66 participants.
Significance: NeW-I aspires to enhance quality of life, spiritual well-being, hope and sense of social support, as well as alleviating depressive symptoms, caregiving burden, and adverse grief outcomes among Singaporean parents facing the terminal illness and eventual death of their sick child. The findings generated will form the foundation of a full-scale RCT for advancing holistic paediatric palliative care and parental bereavement support locally and around the world.
- Being tested
- NeW-I group
- Keywords
- anticipatory grief intervention, randomized controlled trial, narrative therapy, therapist-facilitated e-counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeW-I groupOther
A 5-week intervention offered to parents of children with chronic life-threatening illness using an internet-based narrative approach with life review elements. After completion of the first four weeks of the intervention, participants will receive a 'legacy' document which is a compiled and edited document of their narrative expression during the first four weeks. This legacy document is structured in a manner that enables participants to find a sense of spiritual well-being and hope in their experience of caring for their child through examination of past experiences and achievements as well as future aspirations.
| Study group | Role | What they receive |
|---|---|---|
| NeW-I group | Experimental | Participants engage in a weekly structured writing task of 15-30 minutes which provides them an opportunity to reflect on the emotional, practical and financial demands of caregiving, and the means to cope with these challenges (week 1), explore avenues where they can seek information and resources for caregiving (week 2), explore the sources of support which they have within their network of family and friends (week 3) and examine how they (and their children) can rise above illness-related challenges and live their lives as fully as possible (week 4). After participants complete their weekly writing task, the written narrative will be reviewed and edited by the therapist within the next 3-4 days. The revised draft will be shared with the participant along with constructive feedback, empathic support and psychoeducation. In week 5, participants will receive a 'legacy' document and engage in a voice call with the therapist to receive psychosocial support and for closure of therapy. Receives: Other: NeW-I group |
| Control group | No intervention | Participants engage in a weekly unstructured writing task of 15-30 minutes with a single open-ended question for each week which allows them to respond in any manner they find acceptable. Simple empathic weekly feedbacks are provided by the therapist to encourage continuous participation. In week 5, a consolidated document that includes all unedited journal writings together with a brief summary statement of appreciation by the therapist will be given to participants to indicate conclusion of participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on Kemp Quality of Life Scale (KQOL) from baseline
The KQOL is a single-item easily administered, self-rated global measure of quality of life in adults (Siebens et al., 2015)
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Change in scores on Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) from baseline
The FACIT-Sp-12 is a 12-item questionnaire that examines the relationships between spiritual well-being, health, and adjustment to chronic illness; it has been successfully used to assess spiritual well-being across a wide range of religious traditions, including those who identify themselves as "spiritual yet not religious" (Bredle, Salsman, Debb, Arnold, \& Cella, 2011)
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Change in scores on Herth Hope Index (HHI) from baseline
The HHI is a 12-item adapted version of the Herth Hope Scale that is used in clinical settings to assess hope in adults, to assist in the planning and evaluation of effective hope-enhancing strategies (Herth, 1992).
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Change in scores on Inventory of Social Support (ISS) from baseline
The ISS is a 5-item self-report questionnaire which assess an individuals's satisfaction with their available social support (Hogan \& Schmidt, 2002).
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Change in scores on Patient Health Questionnaire-9 (PHQ-9) from baseline
The PHQ-9 is a 9-item self-administered and brief version of the PRIME-MD diagnostic instrument for common mental disorders; it is a reliable and valid clinical and research tool to assess severity of depressive symptoms (Kroenke, Spitzer, \& Williams, 2001).
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Change in scores on Burden Scale for Family Caregivers-Short Version (BSFC-s) from baseline
The BSFC-s is a 10-item economical instrument for assessing a caregiver's total subjective burden in a short time frame; it is considered an appropriate e outcome measure to evaluate caregiver interventions (Graessel, Berth, Lichte, \& Grau, 2014).
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Change in scores on Brief Grief Questionnaire (BGQ) from baseline
The BGQ is a 5-item self-report instrument for screening complicated grief in clinical and non-clinical settings; it's validity and reliability has been evaluated on different samples including individuals from Asian countries (Ito et al., 2012; Shear, Jackson, Essock, Donahue, \& Felton, 2006).
Measured: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Feb 2019
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Parent of Child With Chronic Life-threatening IllnessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who have completed the online consent form, affirmed their study participation and completed the baseline assessments are then randomly allocated to either the NeW-I group or the control group via the online NeW-I platform that is developed for the purpose of this study. Such random assignment reduces the potential of bias.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Club Rainbow Singapore, Muscular Dystrophy Association Singapore, Rare Disorders Society Singapore
- Responsible party
- Principal investigator, Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684382
- Sponsor's protocol ID
- IRB-2018-07-009
- Acronym
- NeW-I
- Status last verified
- Feb 2019
- First submitted
- 24 Sep 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bredle, J. M., Salsman, J. M., Debb, S. M., Arnold, B. J., & Cella, D. (2011). Spiritual Well-Being as a Component of Health-Related Quality of Life: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). Religions, 2(1), 77-94. https://doi.org/10.3390/rel2010077
Dutta O, Tan-Ho G, Choo PY, Ho AHY. Lived experience of a child's chronic illness and death: A qualitative systematic review of the parental bereavement trajectory. Death Stud. 2019;43(9):547-561. doi: 10.1080/07481187.2018.1503621. Epub 2018 Oct 4.
PubMed 30285557Graessel E, Berth H, Lichte T, Grau H. Subjective caregiver burden: validity of the 10-item short version of the Burden Scale for Family Caregivers BSFC-s. BMC Geriatr. 2014 Feb 20;14:23. doi: 10.1186/1471-2318-14-23.
PubMed 24555474Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
PubMed 1430629Ho, A. H. Y. (2017). A Qualitative Study on the Lived Experience of Bereaved Parents of Young Children with Life Threatening Illness: Advancing Parental Bereavement Support in Singapore and Greater Asia (No. 2017-T1-001-034). Singapore Ministry of Education (MOE) Academic Research Fund (AcRF) Tier 1 Fund.
Ho AHY, Car J, Ho MR, Tan-Ho G, Choo PY, Patinadan PV, Chong PH, Ong WY, Fan G, Tan YP, Neimeyer RA, Chochinov HM. A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial. Trials. 2017 Dec 4;18(1):587. doi: 10.1186/s13063-017-2325-5.
PubMed 29202863Hogan NS, Schmidt LA. Testing the grief to personal growth model using structural equation modeling. Death Stud. 2002 Oct;26(8):615-34. doi: 10.1080/07481180290088338.
PubMed 12243195Ito M, Nakajima S, Fujisawa D, Miyashita M, Kim Y, Shear MK, Ghesquiere A, Wall MM. Brief measure for screening complicated grief: reliability and discriminant validity. PLoS One. 2012;7(2):e31209. doi: 10.1371/journal.pone.0031209. Epub 2012 Feb 14.
PubMed 22348057Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Shear KM, Jackson CT, Essock SM, Donahue SA, Felton CJ. Screening for complicated grief among Project Liberty service recipients 18 months after September 11, 2001. Psychiatr Serv. 2006 Sep;57(9):1291-7. doi: 10.1176/ps.2006.57.9.1291.
PubMed 16968758Siebens HC, Tsukerman D, Adkins RH, Kahan J, Kemp B. Correlates of a Single-Item Quality-of-Life Measure in People Aging with Disabilities. Am J Phys Med Rehabil. 2015 Dec;94(12):1065-74. doi: 10.1097/PHM.0000000000000298.
PubMed 25888654Dutta O, Tan-Ho G, Low XC, Tan THB, Ganapathy S, Car J, Ho RM, Miao CY, Ho AHY. Acceptability and feasibility of a pilot randomized controlled trial of Narrative e-Writing Intervention (NeW-I) for parent-caregivers of children with chronic life-threatening illnesses in Singapore. BMC Palliat Care. 2022 Apr 29;21(1):59. doi: 10.1186/s12904-022-00945-0.
PubMed 35488270Ho AHY, Dutta O, Tan-Ho G, Tan THB, Low XC, Ganapathy S, Car J, Ho RM, Miao CY. A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 5;9(7):e17561. doi: 10.2196/17561.
PubMed 32623367
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Narrative E-Writing Intervention (NeW-I) for Parents of Children With Chronic Life-Threatening Illness
- ClinicalTrials.gov ID
- NCT03684382
- Acronym / sponsor ID
- NeW-I / IRB-2018-07-009
- Keywords
- anticipatory grief intervention, randomized controlled trial, narrative therapy, therapist-facilitated e-counselling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital, Club Rainbow Singapore, Muscular Dystrophy Association Singapore, Rare Disorders Society Singapore
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 25 Sep 2018 (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.
Narrative e-Writing Intervention (NeW-I) is an evidence-based, strength-focused and meaning-oriented approach that aims at enhancing well-being, alleviating burden, and reducing adverse grief outcomes among Singaporean parents caring for a child with chronic life-threatening illness. In collaboration with KK Women's and Children's Hospital and Club Rainbow Singapore, a pilot randomized controlled trial with a built-in qualitative evaluation and feasibility study will be carried out to assess the efficacy of the therapist-facilitated NeW-I protocol and platform among a purposive sample of 66 participants. The findings generated will form the foundation for a full-scale RCT for advancing paediatric palliative care and parental bereavement support.
Detailed description
Background: Conventional grief support interventions for parents whose children are suffering from a chronic life-threatening illness often begin only after the child's death. Despite robust evidence which shows that pre-loss interventions that enhance death preparedness can alleviate psychological distress and prevent adverse grief outcomes among family caregivers of dying patients, there is no known program designed specifically to address the psycho-emotional-spiritual needs of parents facing child loss. And while the National Strategy for Palliative Care in Singapore aims to promote holistic end-of- life care services to patients and their caregivers, vast inadequacy continues to exist in the support provided to parents caring for a dying child in the local context.
Objective and Methods: A novel therapist-facilitated, online intervention is conceived to fill this critical service gap. Adopting an evidence-based approach, the research team has developed a strength-focused and meaning-oriented Narrative e-Writing Intervention (NeW-I) for parents anticipating the death of their child due to a chronic life-threatening condition. The design of NeW-I is informed by an existing body of research (i.e. international systematic review and local qualitative inquiry) that critically examines the lived experience of bereaved parents of children with life- limiting illnesses. NeW-I will be implemented in Singapore in collaboration with KK Women and Child's Hospital and Club Rainbow Singapore. A pilot Randomized Control Trial (RCT) with a built-in accessibility and feasibility study will examine the efficacy of the NeW-I therapeutic protocol for enhancing quality of life, spiritual wellbeing, hope and perceived social support, as well as reducing depressive symptoms, caregiver burden and anticipatory grief among a purposive sample of 66 participants.
Significance: NeW-I aspires to enhance quality of life, spiritual well-being, hope and sense of social support, as well as alleviating depressive symptoms, caregiving burden, and adverse grief outcomes among Singaporean parents facing the terminal illness and eventual death of their sick child. The findings generated will form the foundation of a full-scale RCT for advancing holistic paediatric palliative care and parental bereavement support locally and around the world.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who have completed the online consent form, affirmed their study participation and completed the baseline assessments are then randomly allocated to either the NeW-I group or the control group via the online NeW-I platform that is developed for the purpose of this study. Such random assignment reduces the potential of bias.
| Arm | Type | Receives |
|---|---|---|
| NeW-I group | Experimental | Other: NeW-I groupParticipants engage in a weekly structured writing task of 15-30 minutes which provides them an opportunity to reflect on the emotional, practical and financial demands of caregiving, and the means to cope with these challenges (week 1), explore avenues where they can seek information and resources for caregiving (week 2), explore the sources of support which they have within their network of family and friends (week 3) and examine how they (and their children) can rise above illness-related challenges and live their lives as fully as possible (week 4). After participants complete their weekly writing task, the written narrative will be reviewed and edited by the therapist within the next 3-4 days. The revised draft will be shared with the participant along with constructive feedback, empathic support and psychoeducation. In week 5, participants will receive a 'legacy' document and engage in a voice call with the therapist to receive psychosocial support and for closure of therapy. |
| Control group | No intervention | –Participants engage in a weekly unstructured writing task of 15-30 minutes with a single open-ended question for each week which allows them to respond in any manner they find acceptable. Simple empathic weekly feedbacks are provided by the therapist to encourage continuous participation. In week 5, a consolidated document that includes all unedited journal writings together with a brief summary statement of appreciation by the therapist will be given to participants to indicate conclusion of participation. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mother or father whose child has been diagnosed with a chronic life-threatening illness between the ages of 0-19 years, with a prognosis of more than 3 months since time of study participation so as to ensure successfully completion of all intervention components before child's death.
- Able to speak, read and write in English, as well as to provide informed consent.
Key exclusion criteria (2 listed)
- Cannot provide informed consent
- Suffering from severely high levels of depressive symptoms, anxiety and psychological distress (i. e. score of 19 or higher on Patient Health Questionnaire-9 (PHQ-9) or score of 29 or higher on Kessler Psychological Distress Scale (K-10))
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 |
|---|---|---|
| NeW-I groupA 5-week intervention offered to parents of children with chronic life-threatening illness using an internet-based narrative approach with life review elements. After completion of the first four weeks of the intervention, participants will receive a 'legacy' document which is a compiled and edited document of their narrative expression during the first four weeks. This legacy document is structured in a manner that enables participants to find a sense of spiritual well-being and hope in their experience of caring for their child through examination of past experiences and achievements as well as future aspirations. | Other | NeW-I group |
Primary outcome
Change in scores on Kemp Quality of Life Scale (KQOL) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The KQOL is a single-item easily administered, self-rated global measure of quality of life in adults (Siebens et al., 2015)
Change in scores on Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The FACIT-Sp-12 is a 12-item questionnaire that examines the relationships between spiritual well-being, health, and adjustment to chronic illness; it has been successfully used to assess spiritual well-being across a wide range of religious traditions, including those who identify themselves as "spiritual yet not religious" (Bredle, Salsman, Debb, Arnold, \& Cella, 2011)
Change in scores on Herth Hope Index (HHI) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The HHI is a 12-item adapted version of the Herth Hope Scale that is used in clinical settings to assess hope in adults, to assist in the planning and evaluation of effective hope-enhancing strategies (Herth, 1992).
Change in scores on Inventory of Social Support (ISS) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The ISS is a 5-item self-report questionnaire which assess an individuals's satisfaction with their available social support (Hogan \& Schmidt, 2002).
Change in scores on Patient Health Questionnaire-9 (PHQ-9) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The PHQ-9 is a 9-item self-administered and brief version of the PRIME-MD diagnostic instrument for common mental disorders; it is a reliable and valid clinical and research tool to assess severity of depressive symptoms (Kroenke, Spitzer, \& Williams, 2001).
Change in scores on Burden Scale for Family Caregivers-Short Version (BSFC-s) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The BSFC-s is a 10-item economical instrument for assessing a caregiver's total subjective burden in a short time frame; it is considered an appropriate e outcome measure to evaluate caregiver interventions (Graessel, Berth, Lichte, \& Grau, 2014).
Change in scores on Brief Grief Questionnaire (BGQ) from baseline
Time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.
The BGQ is a 5-item self-report instrument for screening complicated grief in clinical and non-clinical settings; it's validity and reliability has been evaluated on different samples including individuals from Asian countries (Ito et al., 2012; Shear, Jackson, Essock, Donahue, \& Felton, 2006).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- BackgroundBredle, J. M., Salsman, J. M., Debb, S. M., Arnold, B. J., & Cella, D. (2011). Spiritual Well-Being as a Component of Health-Related Quality of Life: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). Religions, 2(1), 77-94. https://doi.org/10.3390/rel2010077
- Background: PubMed 30285557Dutta O, Tan-Ho G, Choo PY, Ho AHY. Lived experience of a child's chronic illness and death: A qualitative systematic review of the parental bereavement trajectory. Death Stud. 2019;43(9):547-561. doi: 10.1080/07481187.2018.1503621. Epub 2018 Oct 4.
- Background: PubMed 24555474Graessel E, Berth H, Lichte T, Grau H. Subjective caregiver burden: validity of the 10-item short version of the Burden Scale for Family Caregivers BSFC-s. BMC Geriatr. 2014 Feb 20;14:23. doi: 10.1186/1471-2318-14-23.
- Background: PubMed 1430629Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
- BackgroundHo, A. H. Y. (2017). A Qualitative Study on the Lived Experience of Bereaved Parents of Young Children with Life Threatening Illness: Advancing Parental Bereavement Support in Singapore and Greater Asia (No. 2017-T1-001-034). Singapore Ministry of Education (MOE) Academic Research Fund (AcRF) Tier 1 Fund.
- Background: PubMed 29202863Ho AHY, Car J, Ho MR, Tan-Ho G, Choo PY, Patinadan PV, Chong PH, Ong WY, Fan G, Tan YP, Neimeyer RA, Chochinov HM. A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial. Trials. 2017 Dec 4;18(1):587. doi: 10.1186/s13063-017-2325-5.
- Background: PubMed 12243195Hogan NS, Schmidt LA. Testing the grief to personal growth model using structural equation modeling. Death Stud. 2002 Oct;26(8):615-34. doi: 10.1080/07481180290088338.
- Background: PubMed 22348057Ito M, Nakajima S, Fujisawa D, Miyashita M, Kim Y, Shear MK, Ghesquiere A, Wall MM. Brief measure for screening complicated grief: reliability and discriminant validity. PLoS One. 2012;7(2):e31209. doi: 10.1371/journal.pone.0031209. Epub 2012 Feb 14.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16968758Shear KM, Jackson CT, Essock SM, Donahue SA, Felton CJ. Screening for complicated grief among Project Liberty service recipients 18 months after September 11, 2001. Psychiatr Serv. 2006 Sep;57(9):1291-7. doi: 10.1176/ps.2006.57.9.1291.
- Background: PubMed 25888654Siebens HC, Tsukerman D, Adkins RH, Kahan J, Kemp B. Correlates of a Single-Item Quality-of-Life Measure in People Aging with Disabilities. Am J Phys Med Rehabil. 2015 Dec;94(12):1065-74. doi: 10.1097/PHM.0000000000000298.
- Derived from this study: PubMed 35488270Dutta O, Tan-Ho G, Low XC, Tan THB, Ganapathy S, Car J, Ho RM, Miao CY, Ho AHY. Acceptability and feasibility of a pilot randomized controlled trial of Narrative e-Writing Intervention (NeW-I) for parent-caregivers of children with chronic life-threatening illnesses in Singapore. BMC Palliat Care. 2022 Apr 29;21(1):59. doi: 10.1186/s12904-022-00945-0.
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Active, not recruiting
SOS for Caregiver Wellbeing
Mental Health, Depression and Burden in Caregivers
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeW-I group in people with Parent of Child With Chronic Life-threatening Illness, run by Nanyang Technological University at 4 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Ho, PhD, EdD (+65 63168943, andyhyho@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on Kemp Quality of Life Scale (KQOL) from baseline (time frame: Baseline, immediately after completion of the intervention/control protocol, one month post intervention/control protocol, three months post intervention/control protocol, six months post intervention/control protocol.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684382, which also lists 13 linked publications.
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 18 Feb 2019.