Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda

Preventing Mental Health Problems After Childhood Severe Malaria



Sponsors

Lead Sponsor



Source

Makerere University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Recruiting

Start Date

2018-01-09

Completion Date

2018-11-30

Primary Completion Date

2018-11-30

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Presence of a behavioral problem
6 months post-discharge

Secondary Outcome

Measure

Time Frame

Maternal anxiety and depression
6 months post-discharge
Behavioral problems in the child
6 months post-discharge

Enrollment

120

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

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.

Arm Group Label

Psychoeducation arm


Intervention Type

Behavioral

Intervention Name


Description

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.

Arm Group Label

Behavioral intervention



Eligibility

Criteria

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.

Gender

All

Minimum Age

18 Months

Maximum Age

4 Years

Healthy Volunteers

No


Overall Contact

Last Name

Paul Bangirana, PhD

Phone

256-772-673831

Email



Location

Facility

Status

Contact

Investigator

Makerere University
Kampala 7072 Uganda
Recruiting
Last Name: Paul Bangirana, PhD
Phone: +256772673831
Email: [email protected]
Last Name: Paul Bangirana, PhD
Role: Principal Investigator

Location Countries

Country

Uganda


Verification Date

2018-02-01

Lastchanged Date

2018-02-12

Firstreceived Date

2018-02-07

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Psychoeducation arm

Arm Group Type

Placebo Comparator

Description

This arm will provide information about admission procedures, story telling and a follow-up phone call


Arm Group Label

Behavioral intervention

Arm Group Type

Experimental

Description

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



Firstreceived Results Date

N/A

Reference

Citation

Ssenkusu JM, Hodges JS, Opoka RO, Idro R, Shapiro E, John CC, Bangirana P. Long-term Behavioral Problems in Children With Severe Malaria. Pediatrics. 2016 Nov;138(5). pii: e20161965. Epub 2016 Oct 5. Erratum in: Pediatrics. 2017 Nov;140(5):null.

PMID

27940786


Citation

Idro R, Kakooza-Mwesige A, Asea B, Ssebyala K, Bangirana P, Opoka RO, Lubowa SK, Semrud-Clikeman M, John CC, Nalugya J. Cerebral malaria is associated with long-term mental health disorders: a cross sectional survey of a long-term cohort. Malar J. 2016 Mar 31;15:184. doi: 10.1186/s12936-016-1233-6.

PMID

27030124



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

Double (Participant, Outcomes Assessor)


Study First Submitted

February 7, 2018

Study First Submitted Qc

February 12, 2018

Study First Posted

February 13, 2018

Last Update Submitted

February 12, 2018

Last Update Submitted Qc

February 12, 2018

Last Update Posted

February 13, 2018


ClinicalTrials.gov processed this data on February 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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