Clinical trial NCT04743024: TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda
Official title: TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda: Screening, Diagnostics, Risk Factors and Handling of Children Drinking Alcohol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcohol Abuse
Alcohol Drinking
Alcoholism
Alcohol Use Disorder
Alcohol Dependence
Child Abuse
Child Malnutrition
Child Neglect
Child Mental Disorder
Child, Only
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Makerere University
name: Norwegian University of Science and Technology
First posted: 2021-02-08
Enrollment: 7188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Child-carer

Brief summary: The investigators will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. The investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. The project is approaching the research topic using quantitative and qualitative methods. The TREAT C-AUD research project will therefore document to which degree alcohol drinking is a problem among children in Mbale, Eastern Uganda.

Detailed description: Uganda has as many other sub-Saharan countries high alcohol consumption per capita and traditions for home brewing. The TREAT C-AUD research project, with partners from Makerere University in Uganda, University of Bergen and Norwegian University of Science and Technology in Norway, will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. The investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. The project is approaching the research topic from comprehensive perspectives including a large cross-sectional study, interviews with parents and carers, children and stakeholders in the communities, schools and in the health system. The investigators have been including community representatives, expert groups, user groups and stakeholders in the development of screening tools and will do so in interpreting and disseminating the results. The investigators have to take the Covid-19 situation into account both with regard to its effect on the research question at stake and the methods used. The TREAT C-AUD research project will therefore document to which degree alcohol drinking is a problem among children in the communities in Mbale District, Eastern Ugandan. The data collection is capturing cofactors such as other substance use, mental health, parenting, trauma, nutrition and growth. The development of alcohol assessment tools can be used by the health- and school-system for detection and handling of children having problems with alcohol. The investigators will collaborate closely with services in case of identification of children suffering severe harm and adhere to Good Clinical Practice guidelines for ethical conduct, the consent procedure, follow-up and referral.

Eligibility criteria: Inclusion Criteria:

Care-giver- child pairs

* Children 6-13 years
* Caregiver of eligible child
* Caregiver adult capable of giving informed consent
* Living in household for minimum 6 months together

Exclusion Criteria:

• Caregiver or child not living in household

Primary outcomes:
measure: Prevalence of alcohol use disorder using context adapted CRAFFT screening tool
timeFrame: 2020-2021
Secondary outcomes:
measure: Parenting: Alabama Parenting questionnaire short form (APQ - 15)
timeFrame: 2020-2021
measure: Parenting: Conflict Tactic Scale (Original: Straus, 1979, we use: Murray 1995) Version: PARENT-CHILD CONFLICT TACTICS SCALES, FORM CTSPC-CA
timeFrame: 2020-2021
measure: Child trauma: Child and Adolescent Trauma Screen (CATS)
timeFrame: 2020-2021
measure: Adult trauma: Stressful Life Events Screening Questionnaire (SLESQ)
timeFrame: 2020-2021
measure: Post traumatic stress disease (PTSD) 2-item checklist
timeFrame: 2020-2021
measure: Child mental health: Pediatric symptom checklist (PSC) - child and adolescent version 35 Mental health measures using Pediatric symptom checklist
timeFrame: 2020-2021
measure: Carer mental health: Self Reporting questionnaire (SRQ) Mental health measures using Pediatric symptom checklist - child version
timeFrame: 2020-2021
measure: Carer substance use: The alcohol use disorder identification test (AUDIT)
timeFrame: 2020-2021
measure: Dietary diversity- 24 hour recall, food categories as specified by food and agriculture organization 2010 (ISBN 978-92-5-106749-9)
timeFrame: 2020-2021
measure: Food frequency questionnaire
timeFrame: 2020-2021
measure: Household food security-HIFAS
timeFrame: 2020-2021
Other outcomes:
measure: Other substance use - sections from Global School Based Health surveys
timeFrame: 2020-2021
measure: Height, in cm, 0.1 nearest cm
timeFrame: 2020-2021
measure: Weight, in kg, 0.1 nearest kg
timeFrame: 2020-21
measure: Mid upper arm circumference, cm 0.1 nearest cm
timeFrame: 2020-21
measure: Urine Etg
timeFrame: 2020-21
measure: Standard U-stix: U-blood, protein, glucose, ketones, nitritt, leukocytes, Ph
timeFrame: 2020-21
Locations:
city: Kampala
country: Uganda
facility: School of Public Health, Makerere University
Study officials:
affiliation: Leader
name: Guri Rørtveit, PhD
role: STUDY_CHAIR
References:
citation: Engebretsen IMS, Nalugya JS, Skylstad V, Ndeezi G, Akol A, Babirye JN, Nankabirwa V, Tumwine JK. "I feel good when I drink"-detecting childhood-onset alcohol abuse and dependence in a Ugandan community trial cohort. Child Adolesc Psychiatry Ment Health. 2020 Oct 24;14:42. doi: 10.1186/s13034-020-00349-z. eCollection 2020.
citation: Akol A, Makumbi F, Babirye JN, Nalugya JS, Nshemereirwe S, Engebretsen IMS. Does mhGAP training of primary health care providers improve the identification of child- and adolescent mental, neurological or substance use disorders? Results from a randomized controlled trial in Uganda. Glob Ment Health (Camb). 2018 Sep 10;5:e29. doi: 10.1017/gmh.2018.18. eCollection 2018.
citation: Akol A, Nalugya J, Nshemereirwe S, Babirye JN, Engebretsen IMS. Does child and adolescent mental health in-service training result in equivalent knowledge gain among cadres of non-specialist health workers in Uganda? A pre-test post-test study. Int J Ment Health Syst. 2017 Aug 24;11:50. doi: 10.1186/s13033-017-0158-y. eCollection 2017.
citation: Skylstad V, Aber H, Bakken V, Dierkes J, Iversen SA, Kisaakye E, Kuhl MJ, Nalugya JS, Rayamajhi D, Sebuwufu D, Skar AS, Skokauskas N, Valeckaite N, Wamani H, S Engebretsen IM, Babirye JN; TREAT C-AUD consortium. Child alcohol use disorder in Eastern Uganda: screening, diagnostics, risk factors and management of children drinking alcohol in Uganda (TREAT C-AUD): a mixed-methods research protocol. BMJ Paediatr Open. 2021 Jul 28;5(1):e001214. doi: 10.1136/bmjpo-2021-001214. eCollection 2021.