Narrative E-Writing Intervention (NeW-I) for Parents of Children With Chronic Life-Threatening Illness

NCT03684382 | Unknown

• 1 other identifier: IRB-2018-07-009
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Parent of Child With Chronic Life-threatening Illness

Keywords

anticipatory grief intervention; randomized controlled trial; narrative therapy; therapist-facilitated e-counselling

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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).

  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).

  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).

  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).

  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).

  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.

Study Arms (2)

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.

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.

Interventions

NeW-I group OTHER

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.

NeW-I group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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))

Sponsors & Collaborators

• Nanyang Technological University: lead
• KK Women's and Children's Hospital: collaborator
• Club Rainbow Singapore: collaborator
• Muscular Dystrophy Association Singapore: collaborator
• Rare Disorders Society Singapore: collaborator

Study Sites (4)

Club Rainbow Singapore

Singapore, 050538, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, 229899, Singapore

NOT YET RECRUITING

Muscular Dystrophy Association Singapore

Singapore, 579837, Singapore

RECRUITING

Rare Disorders Society Singapore

Singapore, 587973, Singapore

RECRUITING

Related Publications (13)

• 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

  BACKGROUND

• 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.

  PMID: 30285557 BACKGROUND

• Graessel 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.

  PMID: 24555474 BACKGROUND

• Herth 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.

  PMID: 1430629 BACKGROUND

• Ho, 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

• 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.

  PMID: 29202863 BACKGROUND

• Hogan 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.

  PMID: 12243195 BACKGROUND

• Ito 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.

  PMID: 22348057 BACKGROUND

• Kroenke 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.

  PMID: 11556941 BACKGROUND

• Shear 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.

  PMID: 16968758 BACKGROUND

• Siebens 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.

  PMID: 25888654 BACKGROUND

• Dutta 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.

  PMID: 35488270 DERIVED

• Ho 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.

  PMID: 32623367 DERIVED

Central Study Contacts

Andy Ho, PhD, EdD

CONTACT

+65 63168943; andyhyho@ntu.edu.sg

Oindrila Dutta, MA

CONTACT

+65 94464402; oindrila001@e.ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Consenting participants are randomly allocated to either the intervention or the control group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 25, 2018
• Study Start: February 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

SG (4)