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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Evaluation of a Narrative E-Writing Intervention (NeW-I) for Parents of Children With Chronic Life-Threatening Illness

Conditions
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Parent of Child With Chronic Life-threatening Illness

Intervention / Treatment
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* Other: NeW-I group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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))

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeW-I group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticipatory grief intervention, randomized controlled trial, narrative therapy, therapist-facilitated e-counselling