Effectiveness of a Training Intervention on Mental Health of Parents for Intellectually Disabled Children in Malawi
Condition: Depression; Learning Disability
MeSH terms: Learning Disabilities; Depression
Study type: Interventional

Summary: 
      Background: It is asserted that 85% of disabled children live in resource poor countries with
      few available disability services. Measurements have shown an increase in disability
      prevalence from 2% to 4% over the past three decades in Malawi. A recent prevalence study in
      Mzuzu city, found 19.7% disability prevalence with associated social and psychological burden
      of care; marriage disruptions and divorces among parents of disabled children due to stigma
      and cultural misconceptions about disability.

      Studies have shown a link between parenting children with intellectual disabilities and
      parental psychological health problems and overall Quality of life. However, with
      interventions, these negative impacts are not as severe as once thought.

      Research Objectives: This study aims to design a Malawi specific Psychosocial Training
      Intervention for parents with intellectually disabled children and assess the impact of the
      Intervention in reducing psychological distress among these parents in Malawi.

      Methodology: This study will use mixed methods design. It will employ an explanatory
      sequential design, where by qualitative data collection and analysis builds to quantitative
      data collection and analysis; and final interpretation.

      The study will be conducted within catchment areas of two disability organisations that are
      operating in Mzuzu and Lilongwe.

      On sample size for the quantitative part, calculation using 5% level of statistical
      significance, power of 90% and effect size of 0.4 [effect size found in recent meta-analysis
      for similar intervention, gives 81 participants in each arm of the intervention.
      Questionnaire with social-demographic data in section one; and "Self-Reported Questionnaire
      will be administered at baseline, 6 & 12 months follow-up. Quantitative data will be coded on
      a computer, cleaned and analyzed using STATA. Mann-Whitney test will be used to measure the
      impact of the intervention. Qualitative data will be analysed using content analysis with the
      help of Nvivo.

      All ethical consideration will be followed to ensure that subjects are treated with respect;
      allow for their right to refuse participation in the study; and conducting interviews in
      privacy.

      Dissemination: Findings will be disseminated through Continous profesional development (CPD)
      sessions at the two clinic sites; Research Dissemination Conferences in Malawi and
      Sub-region; and three manuscripts submission for publication in peer reviewed journals.
    

Detailed description: 
      Background Information and Introduction:

      It is argued that 85% of children with disability live in resource poor countries where there
      are few available disability services. A majority of these children, including their carers,
      suffer the double burden of disability and its associated stigmatization, leading to a
      marginalized life.

      There has been an increase in disability prevalence in Malawi over the past three decades A
      1983 National Statistical Office Survey of Handicapped Persons in Malawi, using head count
      and snowball sampling placed the rate of disability in the population at 2.9% and 10 years
      later it was estimated at 2%. However in a recent prevalence study in Mzuzu city, it was
      found that 154 out of the 780 children sampled (aged 0-18 years) have at least some kind of
      disability according to the Ten Question Questionnaire (a screening tool for disability in
      low income settings comprising five questions on cognitive development; two questions on
      motor development; and one question each regarding vision, hearing and seizures),
      representing 19.7% prevalence. The low prevalence in the earlier surveys may not have
      addressed multiple disabilities unlike in this study where a variety of disabilities
      including physical, intellectual and self-care were studied. In Mzuzu a significant burden of
      care was found among guardians of these children. Much of this related to stigma and cultural
      misconceptions about disability and its causes. Physical, social and psychological burdens
      were reported leading to children being locked up for fear of carrying heavy weight on the
      back as well as stigma; marriage disruptions and divorces between carers ; and general
      distress as a result of having a disabled child.

      It is also clear therefore that in addition to the high burden of disease from childhood
      disability, mental health problems (in particular - depression) in carers only add to this
      burden of disease. To add on the issue of disability, asserts that depressive disorders are
      the leading causes of years lost due to disability in 2004.

      There is no cure for most disabilities, including intellectual disabilities, but
      psycho-social interventions can help parents and carers of children with intellectual
      disabilities. Traditionally, researchers have believed that parenting these children has
      negative impacts on carers. These include increased psychological and physical health
      problems for carers; and physical, social, and financial distress to the whole family. This
      impact most on parents, as they are virtually the only constant carers; leading often to
      increased divorce rates. Recent studies from high income settings have demonstrated that
      these negative impacts are not as severe as once thought. A recent 35-year long study, found
      no significant differences between parents of adult children with and without intellectual
      disabilities on measures of psychological well-being, depression, physical health, and
      divorce.

      The aim for this study is therefore to evaluate the effectiveness of a culturally specific
      Psycho-social Training Intervention on disability on the knowledge and mental health of
      parents with intellectually disabled children, with an aim of rolling it out in Africa if it
      proves to be effective.

      Research hypothesis:

      The research hypothesis to be tested in this study is: The Psycho-social Training
      Intervention that will be developed will be more effective in improving psychological health
      for parents with intellectually disabled children than the usual health talk.

      Methodology:

      Research design: This study will use mixed methods design. An explanatory sequential design
      will be used. This is a design whereby qualitative data collection and analysis builds to
      quantitative data collection and analysis then finalizing with interpretation.

      To complete the whole study, a phenomenological study using focus group discussions and
      indepth interviews will be followed by literature review and then a randomized trial will be
      done to test effectiveness of the developed intervention.

      Section one: Qualitative part Design: The first part of this study will utilize
      phenomenological qualitative research design as it will focus on the lived experiences of
      Parents of Intellectually Disabled Children. A phenomenological design will help to
      understand the psychological issues encountered by Parents of Intellectually Disabled
      Children through their lived experiences. Details for this phase have been detailed in our
      qualitative paper.

      Section two: Literature desk review and Design of the study's intervention:

      Since this study will use a newly developed intervention, there is need to use participatory
      approaches, through focus group discussions with parents of intellectually disabled children
      in order to enhance acceptability and effectiveness of the intervention.

      While some components of the psycho-social training intervention for this study will come
      from the findings in the qualitative study above, a systematic review of literature on
      similar interventions from elsewhere will be conducted to isolate aspects that will feed into
      the culturally relevant intervention to be developed for use in the third phase of the study.
      The third step, a desk review, will be done to contrast the current intervention from
      previous ones that have been developed for use in foreign countries by community staff.

      The review of literature will follow this procedure:

      Review dates and language: Literature to be reviewed will include those from the last ten
      years was searched, with mostly works in English language will be included in this review.

      Databases: Databases to be searched for this purpose will include: Pubmed central, Hinari,
      and Google scholar. Grey literature, including thesis reports and another unpublished works
      will also be reviewed as well as engaging in personal contacts with seasoned authors in this
      field through emails and phone calls where possible. Hand searches and desk review of
      government websites for those countries that have done work in this area will also be
      undertaken to identify wider relevant literature.

      Section three: Design of the intervention and piloting of the intervention:

      The final stage in this phase will be the creation and then piloting of the intervention in
      order to assess the feasibility of intervention for use with parents who have intellectually
      disabled children, and to establish preliminary evidence of efficacy in reducing mental
      health problems among the parents. This will involve pretesting and modifying the
      intervention based on the pretesting results. The piloting will be done with 10 parents
      before the main study using clinic venues which will not be included in the main study.

      Section four: Randomized Wait-list trial study:

      The main study will be a randomized Waiting list-controlled trial. Children with intellectual
      disabilities, (as diagnosed by a psychologist or psychiatric clinical officer using a ten
      question questionnaire), will be consecutively referred and randomly allocated to the study
      in two sites. The intervention group will get Psycho-social Training Intervention while the
      waiting list (control) will continue getting the general health education that is done at
      disability clinics in the existing sites.

      To avoid contamination, the intervention and the control will get their respective training
      on different days (Tuesdays-intervention groups session and Thursday-the control group
      sessions). The study will use blocked randomization (random permuted blocks) which is a
      common form of restricted randomization. This will ensure that subjects assigned to the
      experimental and waiting-control groups are balanced within blocks of, for example, five in
      one group and five in the other for every ten consecutively entered subjects. Follow-up, to
      check the impact of the intervention, will be done at six and twelve months from the time of
      intervention.

      Study population: The study will recruit parents who are caring for intellectually disabled
      children using the inclusion criteria below.

      Site and Sample Size and Sampling: The study will be conducted within catchment areas of two
      disability organizations that are operating in Mzuzu (St John of God), and Lilongwe (Children
      of Blessings Trust).

      On sample size, three factors to be considered in the calculation of sample size are as
      follows: The level of statistical significance, normally 5%; The power, i.e. the probability
      to detect (reach statistical significance) for a given effect size, will be 90%; and The
      effect size is the difference between the two means you want to compare divided by the
      standard deviation. In this case, the affect size of 0.4 as found in recent meta-analysis for
      similar intervention, will be used for this calculation. This gives 81 participants per
      group. However, to factor in a 10% loss to follow-up, (8 subjects) will be added making the
      total number in each group to be 89.

      Plan for data collection: A data collection questionnaire will be developed comprising
      questions on social-demographic data and associated variables in section one and questions
      based on "Self-Reported Questionnaire (SRQ)" to measure psychological distress in section
      two. Self-Reported Questionnaire has already been validated in Malawi. While Tumbuka is
      spoken in the rural northern region, many people in the city of Mzuzu speak Chichewa hence no
      problem is anticipated in participants understanding of the language. The entire
      questionnaire will be administered to all subjects in both groups at Baseline as well as at
      six and twelve months follow-up. These interviews will take 20 minutes each. The training
      will comprise of Ten- 40 minutes sessions conducted twice every week. Participant will be
      expected to attend all training sessions and transport to the venues will be reimbursed.

      All research assistants who will be collecting data (under the supervision of the researcher)
      will be trained in the administration of the questionnaires and the methodology of the study.

      The main study outcome: The main outcome measure will be psychological distress (Measured by
      Self-Reported Questionnaire.

      Plan for data management and analysis Data for this study will be coded on a computer,
      cleaned and analyzed using Statistical package for social scientists.

      At baseline and follow-up screening, the prevalence of common psychological health problems
      among carers will be calculated from the Self-Reported Questionnaire scores. Cases will be
      defined as those scoring 8 or above on the Self-Reported Questionnaire. Total number of
      cases, will be divided by total number of subjects to give the prevalence.

      Since the outcome variables are categorical and continuous, Mann-Whitney test will be used to
      measure the impact of the intervention.

      Plan for dissemination of results Findings of this study will be shared during Journal club
      sessions at the three clinic sites; Research Dissemination Conferences in Malawi and
      Sub-region; and manuscripts will be submitted for publication in peer reviewed journals.

      Ethical Considerations:

      Great care will be taken to ensure that all ethical to ensure that subjects are treated with
      respect allow for their right to refuse participation in the study, and conducting interviews
      in privacy. Further permission to carry out the study will be sought from the two
      institutional heads; ethical clearance will be sought from the College of medicine ethics
      committee; while written informed consent will be sought from all subjects before
      participating in the study.
    

Intervention name(s): Psychosocial intervention
Intervention type(s): Behavioral
Intervention description(s): This training is aimed at Mothers/Fathers/Caregivers/Grandparents of children with intellectual disabilities.
Individual (for severe mental health problems) or group counseling for similar psychological issues should be a vital ingredient of this program. The package runs for 40 hours. It will run for five days continuously. It's important to promote participatory rather than deductive approach allow a lot of time for questions and discussions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Disability; children; parents; depression; knowledge; psychosocial intervention