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Background: Severe malaria is associated with long-term mental health problems in Ugandan children. This study investigated the effect of a behavioural intervention for caregivers of children admitted with severe malaria, on the children’s mental health outcomes 6 months after discharge. Methods: This randomized controlled trial was conducted at Naguru Hospital in Kampala, Uganda from January 2018 to July 2019. Caregiver and child dyads were randomly assigned to either a psycho-educational arm providing information about hospital procedures during admission (control group), or to a behavioural arm providing information about the child’s possible emotions and behaviour during and after admission, and providing age appropriate games for the caregiver and child (intervention group). Pre- and post-intervention assessments for caregiver anxiety and depression (Hopkins Symptom Checklist) and child mental health problems (Strength and Difficulties Questionnaire and the Child Behaviour Checklist) were done during admission and 6 months after discharge, respectively. T-tests, analysis of covariance, Chi-Square, and generalized estimating equations were used to compare outcomes between the two treatment arms. Results: There were 120 caregiver-child dyads recruited at baseline with children aged 1.45 to 4.89 years (mean age 2.85 years, SD = 1.01). The intervention and control groups had similar sociodemographic, clinical and behavioural characteristics at baseline. Caregiver depression at baseline, mother’s education and female child were associated with behavioural problems in the child at baseline (p < 0.05). At 6 months follow-up, there was no difference in the frequency of behavioural problems between the groups (6.8% vs. 10% in intervention vs control groups, respectively, p = 0.72). Caregiver depression and anxiety scores between the treatment arms did not differ at 6 months follow-up. Conclusion: This behavioural intervention for caregivers and their children admitted with severe malaria had no effect on the child’s mental health outcomes at 6 months. Further studies need to develop interventions for mental health problems after severe malaria in children with longer follow-up time. Trail registration ClinicalTrials.gov Identifier: NCT03432039
This was a randomized, controlled trial where children were assigned 1:1 to either a behavioural or psycho-educational treatment. Participants were children aged 1.5 to 4 years. The inclusion criteria were: (a) aged 1.5 to 4 years; (b) admitted with severe malaria necessitating admission and intravenous anti-malarial medication; and, (c) signed informed consent from the caregiver. Severe malaria in this study included: cerebral malaria, severe malarial anaemia, malaria with impaired consciousness (but not in coma or cerebral malaria), and malaria with multiple seizures. The exclusion criteria were: (a) living more than 50 km from the hospital; and, (b) pre-existing developmental delays based on the Ten Questions Questionnaire [11]. The study was conducted at Naguru General Hospital in Kampala city, the capital of Uganda. This site was chosen because of its large catchment area, which enabled the study to obtain a fairly representative sample of Kampala and its surroundings. This intervention was a modified version of the original COPE programme [12]. This is a behavioural intervention that educates the parent about the children's likely emotional and behavioural problems that may result from admission for a critical illness. It provides the parent with skills to deal with these problems and bring about a change in the child's behaviour as outlined below. This intervention (as well as the control intervention) was delivered by a graduate-level psychologist who was not involved in assessment of the study outcomes. The COPE intervention was delivered in three phases with Phase I being delivered within 6 to 16 h of admission to the hospital where caregivers were provided with information about the child's likely emotional reactions during admission in hospital (see Additional file 2; Intervention script). Phase II was delivered within 2 to 16 h of transfer to the general ward and consisted of: (a) verbal and written information to reinforce information provided in Phase I plus additional information on children’s responses during and following hospitalization, as well as to provide further suggestions to enhance coping outcomes in their children; and, (b) parent–child skills-building activities. This consisted of three activities to be completed before discharge from the hospital: (i) doll play to encourage expression of emotions in a non-threatening manner; (ii) therapeutic medical play to assist children in obtaining some sense of mastery and control over the hospital experience; and, (iii) telling a story about a young child who successfully copes with a stressful hospital admission. Parents were encouraged to engage their children in these games thereafter during admission. The modification in this study involved removing audio-taped instructions from Phases I and II, as in the original study, and instead having the intervention delivered face-to-face [12]. Phase III of the behavioural intervention programme occurred 2 to 3 days after hospital discharge and consisted of a telephone call during which a 5-min script was read that reinforced the following: (a) young children’s typical post-discharge emotions and behaviours; and, (b) parenting behaviours which would continue to facilitate positive coping outcomes in their children. Mothers were encouraged to continue performing the activities from Phase II that they received during hospitalization. This intervention also had three phases occurring at the same time as the behavioural intervention [12]. Phase I provided verbal and written information about the paediatric admission unit services and policies. Phase II consisted of: (a) verbal and written information about the general paediatric unit and its policies; and, (b) a parent–child activity having ‘control’ activities, such as reading a story not related to hospital stay. Phase III of the control programme consisted of a telephone call 2–3 days after discharge during which mothers were informed that they should contact their primary healthcare providers if their children were having any problems or unusual symptoms. They were also asked to comment on their children’s hospital stays during this telephone call (see Additional file 1; control script). The games and stories of the interventions were different for the age groups. The hospital in which the study was conducted has an open general ward for children, which made it impossible to separate participants from the different arms while on the ward to prevent them from observing different games and activities of the other intervention. Primary and secondary outcomes were assessed during admission prior to the intervention and at 6 months after discharge. Presence of a behavioural problem was the primary outcome of the study, which was assessed using the self report Strengths and Difficulties Questionnaire (SDQ) [13, 14]. It has 25 items assessing five domains of five items each: emotional, conduct, hyperactivity, peer, and prosocial problems. Summation of scores from the first four scales gives the total difficulties score, which was the primary outcome measure for the SDQ [14]. The SDQ has been used in Uganda to screen for behavioural problems, including a study on children with severe malaria and has proven a valid measure in this region with a sensitivity of 60% when compared with a diagnostic interview [3, 15–17]. In the present study, the internal reliability of the SDQ was 0.60. A score of 17 or more was indicative of behavioural problems. Total behavioural problems score in the children were assessed using the preschool version of the Child Behaviour Checklist (CBCL) [18], which was a secondary outcome of the study. The CBCL has 100 items about a child’s behaviour that the parent responds to, which can be summarized into seven sub-scales which are further summarized into externalizing, internalizing and total problems [19]. The CBCL has been used in several studies in Uganda and is reliable in assessing behaviour over time with test–retest reliabilities for its scales ranging from 0.64 to 0.83 [4, 20]. The CBCL has not been compared with a structured clinical interview for validation in the study’s setting. It was included to supplement the SDQ, given its broad assessment of behavioural problems using its widely used syndrome scales [21]. Maternal depression and anxiety were secondary outcomes which were assessed using the 25-item version of the Hopkins Symptom Checklist (HSCL) [22]. Anxiety and depression are common outcomes in parents whose children have been in ICU [23]. The HSCL has 25 items with the first 10 assessing anxiety and the next 15 assessing depression. Its reliability ranges from 0.83 to 0.91 for the different subscales and has a sensitivity of 81% in Ugandan adults [24]. A socio-economic status form used in previous studies in Uganda was used to measure the material possessions of the family, housing type, cooking resources and water source [25, 26]. These were scored and summed up to obtain a socio-economic status score. The Ten Questions questionnaire [11, 27] was used to screen for children with neurodevelopmental delay who could have pre-existing behavioural problems that could confound the intervention outcomes. It is a widely used screen for neurodevelopmental disabilities used in a field survey of neurodevelopmental disabilities in Uganda [28]. In the original COPE trial, an absolute difference of 23.6% in the prevalence of behavioural problems between the control and COPE arms (25.9% vs. 2.3%, respectively) was observed 12 months after the intervention [12]. In the proposed study, the 6-month assessment was the primary endpoint. Assuming the COPE arm to have 2.3% with behavioural problems [12] and the control arm would have the same rate as observed in Idro et al. (18.5%) [3], a sample size of 55 per group was needed for a study powered at 80%. Assuming a loss to follow-up of 10%, 60 children per arm were targeted for enrolment. Stratified randomization was done by age groups, i.e., 1 year old band, 2 years old band, 3 years old band, and 4 years old band were randomized individually. For each of these age groups, random numbers were computer generated by the first author and the treatment allocation kept in sealed opaque envelopes serially numbered to conceal allocation. The psychologist administering the intervention had custody of these envelopes, which she opened to reveal the treatment group once a participant was enrolled by the study nurse. Assessors of the child’s mental health were blinded to the child’s treatment arm allocation by not involving them in providing the intervention or access to group allocation envelopes. Caregivers were also blinded to the child’s treatment allocation, however because it was impossible to separate them on the ward, there is a possibility they may have observed different interventions being given to other children. Data were entered into FileMaker with validation checks and exported to IBM SPSS Statistics for Windows, version 26 (IBM Corp., Armonk, NY, USA) for analysis. The Chi square test was used to compare the rates of children with a behavioural problem between the two groups. T-tests were used to compare continuous scores between the study groups. Analysis of covariance controlling for maternal anxiety and child’s gender was used to compare 6-month behavioural problems in the treatment arms. To account for multiple variables, outcome measurements were compared between the intervention and control groups using generalized estimating equations (GEE) with robust standard errors and assuming an exchangeable correlation structure between the measurements at the two-time points.
