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Effectiveness of a Training Intervention on Mental Health of Parents for Intellectually Disabled Children in Malawi

NCT02827396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2016-07-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Psychosocial intervention

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.

Sponsors & Collaborators

  • St John of God, Malawi

    lead OTHER

Principal Investigators

  • Don Mathanga, PhD · College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-07-31
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02827396 on ClinicalTrials.gov