Preventing Mental Health Problems After Childhood Severe Malaria

NCT03432039 | Completed

• 1 other identifier: REC 2017-088
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Presence of a behavioral problem

  Children whose scores on the Strength and Difficulties score for Total Problems is above 17

  6 months post-discharge

Secondary Outcomes (2)

• Maternal anxiety and depression

  6 months post-discharge

• Behavioral problems in the child

  6 months post-discharge

Study Arms (2)

Psychoeducation arm

PLACEBO COMPARATOR

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

Behavioral: Psychoeducation

Behavioral intervention

EXPERIMENTAL

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

Interventions

Psychoeducation BEHAVIORAL

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.

Psychoeducation arm

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.

Behavioral intervention

Eligibility Criteria

• Age: 18 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Living more than 50km from the hospital
• pre-existing developmental delays based on the Ten Questions Questionnaire

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Makerere University

Kampala, 7072, Uganda

Location

Related Publications (3)

• 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):e20161965. doi: 10.1542/peds.2016-1965. Epub 2016 Oct 5.

  PMID: 27940786 BACKGROUND

• 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 BACKGROUND

• Bangirana P, Birabwa A, Nyakato M, Nakitende AJ, Kroupina M, Ssenkusu JM, Nakasujja N, Musisi S, John CC, Idro R. Use of the creating opportunities for parent empowerment programme to decrease mental health problems in Ugandan children surviving severe malaria: a randomized controlled trial. Malar J. 2021 Jun 13;20(1):267. doi: 10.1186/s12936-021-03795-y.

  PMID: 34120616 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 13, 2018
• Study Start: January 9, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)