Trial record 51 of 209 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Preventing Mental Health Problems After Childhood Severe Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03432039
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Makerere University

Brief Summary:
This is a randomized trial in which caregivers of children suffering from malaria will be assigned to two treatment conditions to prevent mental health problems in the children. A psycho-education arm (control) and a behavioral arm (intervention). Pre- and post-intervention assessments for behavioral problems in the child and mother will be carried out.

Condition or disease Intervention/treatment Phase
Malaria Behavioral: Psychoeducation Behavioral: Behavioral Not Applicable

Detailed Description:
This study is designed to prevent mental health problems in children after an episode of severe malaria. The effect of the intervention on the mother's psychological wellbeing will also be assessed. Both caregivers and children will be assessed on the ward before being randomly assigned to the treatment arms. The interventions in both arms will be done in three phases with the third phase being done at home after discharge. Post-intervention assessments will be done on both the caregivers and mothers 6 months after discharge.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Psychoeducation arm
This arm will provide information about admission procedures, story telling and a follow-up phone call
Behavioral: Psychoeducation
This intervention has three phases occurring the same time as the Psychoeducation intervention. Phase I provides verbal and written information about the paediatric acute care unit services and policies. Phase II consists of: (a) verbal and written information about the general paediatric unit and its policies, and (b) a parent-child activity having ''control'' activities like reading a story not related to hospital stay. Phase III of the control program consists of a telephone call 2-3 days after discharge during which time mothers were informed that they should contact their primary healthcare providers if their children were having any problems or unusual symptoms. They also were asked to comment on their children's hospital stays during this telephone call.

Experimental: Behavioral intervention
This arm will provide information about what invasive procedures maybe given to the child, the emotional and behavioral reactions of the child while on the ward, games and stories that the child can engage with the mother and a follow-up phone call
Behavioral: Behavioral
This is an educational-behavioural intervention that educates the parent about the children's likely emotional and behavioural problems that may result from ICU admission. Phase I will be delivered within 6 to 16 hours of admission to the hospital where caregivers are provided with information about the child's likely emotional reactions during admission in hospital. Phase II will be delivered within 2 to 16 hours of transfer to the general ward and will consist of: (a) verbal and written information to reinforce information provided in Phase I and (b) a parent-child skills building activities. Phase III of the COPE intervention program will occur 2 to 3 days after hospital discharge and will consist of a telephone call during which a 5 minute script will be read that reinforces young children's typical post-discharge emotions and behaviours and parenting behaviours which would continue to facilitate positive coping outcomes in their children.

Primary Outcome Measures :
  1. Presence of a behavioral problem [ Time Frame: 6 months post-discharge ]
    Children whose scores on the Strength and Difficulties score for Total Problems is above 17

Secondary Outcome Measures :
  1. Maternal anxiety and depression [ Time Frame: 6 months post-discharge ]
    Anxiety and depression scores as measured by the Hopkins Symptom Checklist

  2. Behavioral problems in the child [ Time Frame: 6 months post-discharge ]
    Total Problems score of the Child Behavioral Checklist

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 1.5 to 4 years
  • admitted with severe malaria necessitating admission and intravenous treatment
  • signed informed consent from the caregiver. Severe malaria in this study will include; cerebral malaria, severe malarial anemia, malaria with impaired consciousness (but not in coma or CM) and malaria with multiple seizures.

Exclusion Criteria:

  • Living more than 50km from the hospital
  • pre-existing developmental delays based on the Ten Questions Questionnaire
  • pre-existing mental disorder based on baseline CBCL results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03432039

Contact: Paul Bangirana, PhD 256-772-673831

Makerere University Recruiting
Kampala, Uganda, 7072
Contact: Paul Bangirana, PhD    +256772673831   
Principal Investigator: Paul Bangirana, PhD         
Sponsors and Collaborators
Makerere University

Responsible Party: Makerere University Identifier: NCT03432039     History of Changes
Other Study ID Numbers: REC 2017-088
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases