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

NCT02827396 | Completed DMC

• 1 other identifier: SJOG594
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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

Depression; Learning Disability

Keywords

Disability; children; parents; depression; knowledge; psychosocial intervention

Outcome Measures

Primary Outcomes (1)

• Psychological distress (Self reported Questionnaire {SRQ})

  SRQ screens for common psychological health problems using a 20 items scale

  1 year

Study Arms (2)

Psycho-social intervention

EXPERIMENTAL

Experimental group: The intervention group will get Psycho social Training Intervention which will be developed during the third phase of the study.

Behavioral: Psychosocial intervention

TAU intervention

NO INTERVENTION

Wait-list (controlled) group: The waiting list (control) group will continue getting the general health education (TAU) that is done at disability clinics in the existing sites.

Interventions

Psychosocial intervention BEHAVIORAL

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.

Psycho-social intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be included on the following criteria:
• Being carers of children with an intellectual disability, aged at least 18 years, for at least a year;
• Readiness to consent for the study on a voluntary basis, and
• Commitment to attend all training sessions, and
• Willingness to complete home assignments between training sessions.

You may not qualify if:

• Subjects will be excluded on the following criteria:
• Aged less than 18 years,
• Having a psychiatric of being mentally unsound at the time of enrollment.

Sponsors & Collaborators

• St John of God, Malawi: lead

Related Publications (1)

• Quinn, Mark, et al.

  BACKGROUND

MeSH Terms

Conditions

Depression; Learning Disabilities

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Don Mathanga, PhD

  College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: July 11, 2016
• Study Start: December 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share