Clinical trial NCT06166550: Improving Psychological Wellbeing by Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders
Official title: Improving Psychological Wellbeing Through Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders: A Multi-pronged Intervention in Bangladesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: Psychological wellbeing
Neurodevelopmental Disorder
Parental Stress
Emotional Intelligence
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention is based on Emotional Intelligence. A training session will be given in-person; a diary and a mobile app will be given to practice emotional intelligence at home.
Primary purpose: PREVENTION

Brief summary: 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.

The study will be conducted in Child Development Centers in public medical college hospitals across Bangladesh. It will assess changes in parental stress, mental well-being, and emotional intelligence. Data collection will occur from April 2024 to October 2024.

The project aims to recruit 480 parents from eight Child Development Centers, ensuring ethical considerations, data integrity, and participant privacy. The findings will be shared through national dissemination seminars, policy briefs, reports, and journal publications.

Detailed description: 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's 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 is centered around the Institute of Paediatric Neurology and Autism (IPNA) and Child Development Centers or Shishu Bikash Kendra (SBKs) in Bangladesh's eight administrative divisions. IPNA at BSMMU provides care, education, and training, impacting national mental health policy. Additionally, fifteen government medical college hospitals operate SBKs as outdoor services. These centers offer specialized care for children with NDDs through a multidisciplinary team.

Eligibility criteria:

Parents aged 18 to 50 years with children having neurodevelopmental disorders (e.g., Autism, Cerebral Palsy, Intellectual disorders, ADHD, and Down Syndrome) diagnosed at the SBKs 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 will develop an intervention module and a mobile app/software for parents of children with NDDs. The intervention will focus on enhancing emotional intelligence and stress reduction, with two interactive sessions covering emotional awareness, regulation, empathy, and interpersonal skills. Two groups will be involved: Group A (Training, diary \& app users), and Group B (Control). Group A will receive in-person training and access to the app, and Group B will be in wait-list control group. The wait-list control group will receive the intervention after the intervention period is over. The aim is to improve emotional intelligence to handle life's stress. Morning and evening sessions will be available for working parents, and those needing pharmacological management will be referred to relevant department. The mobile app/software and the diary will support 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 April 2024 to October 2024. From April to October 2024, we'll evaluate parenting stress and psychological wellbeing. Secondary outcomes include emotional intelligence, parenting self-efficacy, perceived social support, parenting satisfaction, and marital satisfaction during the same period.

Sample Size and recruitment process:

Investigators used a sample size calculator to determine the sample size. The average cluster size will be 60 and cluster number will be 8. Adjusted for clusters, the maximum sample size is 480 parents. Eight SBKs, one per administrative division, will be randomly assigned to intervention and control groups in a 1:1 ratio. They will provide lists of recently diagnosed children. Investigators will invite both parents 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 will receive the intervention, while Group B serves as the control. Follow-up evaluations at 8 weeks will measure stress and well-being using TEIQue-SF and WHO-5 wellbeing scale. After 8 weeks, Group B will receive the intervention.

Statistical methods:

Principles of analysis: The population for the primary outcome analysis will consist of all recruited parents who received two sessions of intervention and for whom both baseline and post intervention follow-up data will be available. If a participant moves to the catchment area of another SBK after baseline measure is collected (i.e., crossover from intervention to control, or vice versa), the instances will be documented, and removed from the trial. As the final population in the primary analysis will exclude the participants who will be lost to follow-up (i.e., for whom follow-up data is not available), a sensitivity analysis will be performed to account for all randomized participants.

Descriptive analysis: Socio-demographic data of the participants e.g., gender, occupation, education status, family history of neurodevelopmental disorders, etc. will be obtained. All categorical variables will be summarized in frequency and percentages, and continuous variables in mean and standard deviation. To estimate the association of these characteristics with parenting stress and psychological wellbeing, t-tests and chi-square tests will be done.

Inferential analysis: To estimate the efficacy of the intervention, before-after data will be analyzed, and paired t-test and McNemar's chi-square tests will be done in this regard. A comparison will also be made between the intervention and the control data, both at pre- and post- intervention level. Difference-in-difference analysis will be done to estimate the intervention effects among participants by age groups, sex, socio-economic status, etc.

Association analysis: Binary regression analysis will be done to estimate the association between socio-demographic variables with changes in the outcome variables, change in parenting stress and psychological wellbeing.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wellbeing
timeFrame: 8 weeks after completion of two-day intervention
measure: Mental Health
timeFrame: 8 weeks after completion of two-day intervention
measure: Parenting stress
timeFrame: 8 weeks after completion of two-day intervention
Secondary outcomes:
measure: Emotional intelligence
timeFrame: 8 weeks after completion of two-day intervention
measure: Parenting Self-Efficacy
timeFrame: 8 weeks after completion of two-day intervention
Other outcomes:
Locations:
Study officials:
affiliation: Center for Injury Prevention and Research Bangladesh
name: Salim M Chowdhuri, PhD
role: STUDY_DIRECTOR
References: