A group interpersonal psychotherapy intervention for caregivers of children with nodding syndrome to improve the mental health of both

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN11382067
• Date of registration: 08/06/2016
• Prospective Registration: No
• Primary sponsor: Makerere University
• Public title: A group interpersonal psychotherapy intervention for caregivers of children with nodding syndrome to improve the mental health of both
• Scientific title: Effectiveness of a family based group interpersonal psychotherapy intervention (IPT-F) for caregivers of children with nodding syndrome to improve the mental health of both in comparison to usual care
• Date of first enrolment: 02/09/2013
• Target sample size: 132
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11382067
• Study type: Interventional
• Study design: Single centre quasi experimental (intervention cohort) study design (Treatment)
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Byamah Mutamba

Key inclusion & exclusion criteria

Inclusion criteria: 1. A caregiver will be included in the study if she/he is an adult =18 years of age
2. Is living in the selected study parishes
3. Is a primary caregiver for a patient (child/adolescent) with Nodding Syndrome
4. Gives informed written consent
5. Gives assent for and presents with one of their NS-affected children for assessment
Exclusion criteria: 1. Is severely ill and unable to participate in the study
2. Does not give informed written consent to participate in the study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Common mental disorders
Mental and Behavioural Disorders

Intervention(s)

There are two arms in the trial; intervention and control. To obtain the participants in the intervention arm, caregivers are consecutively selected based on updated lists of caregivers from the local health facility NS (Nodding syndrome) register at Atanga Health centre and from Village Health Team (VHT) members resident in selected study parishes of Atanga sub-county. The participants for the control arm will be randomly chosen from an updated list of caregivers resident in selected study parishes in Awere sub-county.

The group interpersonal psychotherapy intervention (IPT-F) will involve weekly group sessions each lasting 1 and a half hours delivered by trained village health team (VHT) members for a period of 12 weeks. The VHT members will be supervised by trained health workers from the local health facility.

Caregivers in the control parishes will access the usual care as provided for in the national response plan for NS.The national response plan for NS includes health education about NS for affected communities, management of patients with NS , caregiver education and counselling at health facilities and designated treatment centres, outreach clinics and home visits to families affected by the syndrome.

Patients in both study arms will continue to receive the usual care during and after the intervention period.

The activities conducted during each of the 12 IPT-F weekly sessions depends on which session it is in the 12 week schedule.
During the first phase (sessions 1 and 2), the facilitator:
1. Helps group members develop rapport among themselves, feel comfortable in the group so that they can talk about how they feel and what is happening in their lives
2. Explains that everyone in the group has depression and can help one another
3. Explains that

Primary Outcome(s)

Proportion of caregivers with improved mental health status ( a decrease in proportion of caregivers with depression) after one year follow up, assessed using mini plus neuropsychiatric interview (depression module)

Secondary Outcome(s)

1. The proportion of caregivers with:
1.1. Generalised anxiety disorder (GAD) measured using mini plus neuropsychiatric interview (GAD module.
1.2. Post traumatic stress disorder (PTSD) measured using mini plus neuropsychiatric interview (PTSD module)
1.3. A high risk of suicide measured using mini plus neuropsychiatric interview(suicide module)
1.4. High levels of psychological distress measured using the self-report questionnaire
1.5. Low levels of functioning measured using the assessment of functioning questionnaire
1.6. Low levels of social support measured using the social support scale
1.7. High levels of stigma measured using the devaluation of consumer’s scale

2. Proportion of affected children with:
2.1. An abnormal total difficulties score measured using the strengths and difficulties questionnaire
2.2. High parent attachment scores measured using the inventory of parent and peer attachment questionnaire
2.3. Depression measured using the depression self-rating scale
2.4. Separation anxiety disorder measured using the mini kid neuropsychiatric interview
2.5. Generalised anxiety disorder measured using the mini kid neuropsychiatric interview
2.6. Attention deficit hyperactivity disorder measured using the mini kid neuropsychiatric interview
2.7. Psychological trauma measured using the revised child impact of events scale

Secondary ID(s)

S4 0232-01

Source(s) of Monetary Support

Grand Challenges Canada

Secondary Sponsor(s)

Uganda National Council for Science and Technology

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Makerere University College Of Health Sciences, School Of Public Health. Higher Degrees Research and Ethics Committee, 14/06/2013, ref: IRB00011353

Results

• Results available: Yes
• Date Completed: 30/09/2014