Improving Psychological Wellbeing by Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders

Study Overview
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Brief Summary
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This project addresses the mental health challenges faced by parents caring for children with Neurodevelopmental Disorders (NDDs) in Bangladesh. These parents often experience high levels of stress, anxiety, and depression, impacting family dynamics and the child's development. The project aims to design, implement, and assess an intervention to reduce parenting stress and enhance parental well-being. This intervention focuses on emotional intelligence and will be delivered through in-person training and a mobile app. The study will use a cluster randomized controlled trial methodology, targeting parents of children diagnosed with NDDs in the past six months. The study will be conducted in healthcare facilities and Child Development Centres across Bangladesh. It will assess changes in parental stress, mental well-being, and emotional intelligence, as well as their impact on child behavior and parental self-efficacy. Data collection will occur from October 2023 to October 2024. The project aims to recruit 400 parents from eight Child Development Centers, ensuring ethical considerations, data integrity, and participant privacy. The findings will be shared through various channels, ultimately improving the well-being of caregivers and children affected by NDDs in Bangladesh.

Detailed Description
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Background and Rationale: Neurodevelopmental disorders (NDDs) are a global public health concern, often causing parents to grapple with increased stress, anxiety, and reduced well-being. This compromised mental health among caregivers persists throughout a child's development, straining family dynamics and making effective parenting more challenging. Research underscores the importance of addressing caregiver well-being, as it indirectly impacts the child's health and development. In Bangladesh, where social stigma and limited support exacerbate the challenges, there is a lack of research on stress management to improve parental well-being. Empirical studies are essential to enhance the psychological health of caregivers of children with NDDs in Bangladesh and promote their long-term caregiving abilities. Objectives: The project aims to develop an evidence-based intervention to reduce parenting stress and enhance the mental health of parents with children with neurodevelopmental disorders. This intervention will be implemented in healthcare and community settings and evaluated through process and outcome measures, including changes in parenting stress. Trial design: The trial will adopt a parallel design and employ a cluster randomized controlled trial (CRCT) methodology. Methods: Study settings: The study focuses on IPNA and SBKs in Bangladesh's eight administrative divisions. IPNA at BSMMU provides care, education, and training, impacting national mental health policy. Additionally, ten nonprofit hospitals operate SBKs in the US, with thirty-four state-run SBKs. These centers offer specialized care for children with NDDs through a multidisciplinary team. Eligibility criteria: Parents aged 18 to 50 with children having neurodevelopmental disorders (e.g., Autism, Cerebral Palsy, Intellectual disorders, ADHD, Down Syndrome) diagnosed within the past six months are eligible. Exclusions include parents of children with sensory impairments, oxygen-dependent chronic lung disorders, or requiring initial pharmacological care. An implementation guide will be created, facilitators trained in emotional intelligence, and community mobilizers trained for SBK-based campaigns to ensure smooth intervention implementation. Intervention: Investigators'll develop an intervention module and a mobile app/software for parents of children with neurodevelopmental disorders. The intervention will focus on enhancing emotional intelligence and stress reduction, with six interactive sessions covering emotional awareness, regulation, empathy, and interpersonal skills. Three groups will be involved: Group A (Training & app users), Group B (App users), and Group C (Control). Group A receives in-person training and access to the app, Group B has the app but no training, and Group C receives no intervention. The aim is to improve emotional intelligence to handle life's stress. Morning and evening sessions are available for working parents, and those needing pharmacological management will be referred. An SBK-based awareness campaign will run alongside the emotional intelligence intervention, targeting parents and the community to reduce parenting stress and enhance parental well-being through EI training-based research. The mobile app/software supports parents in improving their emotional intelligence skills, benefiting family well-being and the child with special needs. Outcomes: This study's aim to assess the intervention's feasibility and acceptance in Bangladesh's Child Development Centers and among the targeted parents from October to December 2023. From November 2023 to October 2024, we'll evaluate mental health (stress, anxiety, depression, well-being) and emotional intelligence. Secondary outcomes include monitoring changes in a child's behavior and assessing parents' self-efficacy during the same period. Sample Size and recruitment process: Investigators used a sample size calculator to determine our sample size. With the goal of reducing parenting stress by 30% among parents of children with NDDs, selected 60 as the uncorrected sample size. Adjusted for clusters, the maximum sample size is 400 parents. Eight SBKs, one per administrative division, will be randomly assigned to intervention and control groups in a 3:1 ratio. They will provide lists of recently diagnosed children. Investigators 'll invite both parents when possible and continue recruiting until they reach the required sample size. Methods: Data Collection methods and data management: Data collection steps involve contacting prospective parents to participate. Baseline data collection occurs at selected SBKs with self-administered questionnaires on parenting style, stress, and mental health. Groups A and B receive the intervention, while Group C serves as the control. Follow-up evaluations at three and six months measure stress, well-being, and parent-child relationships using PHQ-9, SDQ, TEIQue-SF, and WHO-5. Qualitative research includes interviews and observations to explore current practices for addressing parenting stress and intervention feasibility. Key Informant Interviews (KII) will involve government, non-government, academic, and healthcare participants, while In-depth Interviews (IDIs) will be conducted with parents of children with neurodevelopmental disorders to understand their challenges and coping mechanisms. Statistical methods: This study combines qualitative and quantitative methods for analysis. Transcripts are cross-checked immediately after each interview. Data analysis begins once the first transcript is ready. Qualitative content analysis follows a strategic strategy as per Alase (2017) and Creswell's (2014) suggestions. For the statistical analysis, recruited parents attending at least six sessions with baseline and post-intervention data are included. Participants relocating to different catchment areas are noted and excluded. All randomized participants, including those lost to follow-up, are considered in sensitivity analysis. Socio-demographic information is summarized. Continuous data as means and standard deviations, categorical data as frequencies and percentages. T-tests, chi-square tests, paired t-tests, McNemar's chi-square tests, difference-in-difference analysis, and binary regression analysis are used to assess the intervention's effectiveness and its impact on various participant subgroups. Qualitative and quantitative approaches evaluate the intervention process, including data collection techniques, participant recruitment and retention rates, session attendance, and acceptability through rates, reasons for dropouts, preference ratings, and parent experiences with the intervention. Data monitoring: The Data Monitoring Committee (DMC) plays a vital role in ensuring the study's integrity and security. Comprising impartial specialists in mental health, neurodevelopmental disorders, and research ethics, they independently monitor the study. Their main responsibility is to safeguard participants' rights and well-being by examining data, tracking study progress, and assessing risks or adverse outcomes related to the intervention. The DMC also ensures research techniques and analyses are appropriate and objective, maintaining scientific rigor. Ultimately, they provide essential oversight, enhancing credibility and upholding ethical standards while advancing knowledge in neurodevelopmental disorders and parental well-being. Ethics and dissemination: An informed consent will be sought from each participant prior to the collection of data, detailing the study's objectives, procedures, advantages, risks, and the identity of the lead investigator. This research protocol has received approval from the Institutional Review Board at BSMMU. Participants will be given unique ID numbers, and all information will be encrypted and kept confidential to preserve privacy, anonymity, and secrecy. The information gathered will only be utilized for study. Confidentiality: Local-level problems including non-cooperation and non-response are anticipated hurdles and barriers. These issues will be handled by rapport-building, sensitivity, and choosing the right responders. Respondents will be guaranteed of the privacy of their data while confidentiality will be upheld. Following governmental directives, general contextual elements, including the COVID-19 problem, will be managed. The management of capacity issues and team dropout will involve ongoing observation, communication, and additional training. Dissemination policy: In this project, Investigators are committed to sharing their research findings widely for maximum impact. Our dissemination strategy includes publishing in open-access academic journals, creating plain language summaries for accessibility, participating in conferences to engage with experts and practitioners, conducting community workshops, developing policy briefs for government agencies, collaborating with NGOs, and responsibly sharing de-identified data with fellow researchers. Our goal is to reach a diverse audience, including parents, healthcare professionals, policymakers, and researchers, to enhance the well-being of parents and children with neurodevelopmental disorders in Bangladesh and beyond.

Official Title
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Improving Psychological Wellbeing Through Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders: A Multi-pronged Intervention in Bangladesh

Conditions
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Mental Health Issue

Intervention / Treatment
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* Behavioral: Parent's Emotional Intelligence Network


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of any age having children with neurodevelopmental disorders i.e. Autism Spectrum Disorders, Cerebral Palsy, Intellectual disorders, attention deficit hyperactivity disorders, and Down Syndrome. Parents of children whose diagnosis were made within one year (to avoid the time-effect on stress and mental health). Parents' age limit will be 18-50 years Exclusion Criteria: Parents having children with serious sensory impairments (e.g., deafness and blindness) and oxygen dependence due to chronic lung diseases. Parents who need pharmacological management at initial assessment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It's a training based on Emotional Intelligence. It will be given by two methods, one method will be included by in-person intervention & another method will be included by mobile app.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>Parents of children suffering from neurodevelopmental disorders will be the participants. They will get in-person training on emotional intelligence, stress reduction, and wellbeing along with access to a mobile app aimed at enhancing their psychological wellbeing. | Behavioral: Parent's Emotional Intelligence Network<br>* Intervention will be given in 2 group, mentioned group is Training, App user. Training group is experimental group and they will get intervention by in-person, App user will get by mobile app and Control Group will not get any intervention<br>|
| Sham Comparator: App user<br>Participants in this arm will not get any in-person training. Rather, they will be given access to the same mobile app which Group A will receive. | Behavioral: Parent's Emotional Intelligence Network<br>* Intervention will be given in 2 group, mentioned group is Training, App user. Training group is experimental group and they will get intervention by in-person, App user will get by mobile app and Control Group will not get any intervention<br>|
| No Intervention: Control<br>Experimental | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing | WHO (five) Well-Being Index will be used to measure mental wellbeing both before and after the intervention. | 3 months after completion of 2 days intervention | 
| Mental Health | Mental health status will be assessed by Depression, Anxiety, and Stress Scale (DASS 9). | 3 months after completion of 2 days intervention | 
| Parenting stress | Parenting stress will be assessed by Parental Stress Scale, a 18-item Likert scale. | 3 months after completion of 2 days intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional intelligence | Parent's emotional intelligence will be assessed by Trait Emotional Intelligence Questionnaire-Short Form (TEIQue-SF). | 3 months after completion of 2 days intervention | 
| Parenting Self-Efficacy | Parenting Self-Efficacy will be measured by parenting Self-Efficacy scale | 3 months after completion of 2 days intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological wellbeing, Neurodevelopmental Disorder, Parental Stress, Emotional Intelligence