TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda (TREAT C-AUD)

TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda: Screening, Diagnostics, Risk Factors and Handling of Children Drinking Alcohol

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Alcohol Dependence; Alcoholism; Child Abuse; Alcohol Use Disorder; Child, Only; Child Mental Disorder; Alcohol Abuse; Child Neglect; Child Malnutrition

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.

• Study Type: Observational
• Enrollment (Estimated): 7188

Contacts and Locations

• Study Contact: Name: Ingunn MS Engebretsen, PhD; Phone Number: +4755588553 +4755588553; Email: ingunn.engebretsen@uib.no
• Study Contact Backup: Name: Anne-Berit Kolmanskolg, Ms; Phone Number: +47 55 58 54 39; Email: Anne.Kolmannskog@uib.no

Study Locations

• Uganda
  • Kampala, Uganda
    • Recruiting
    • School of Public Health, Makerere University
    • Contact: Juliet N Babirye, PhD; Phone Number: +256790214320; Email: jnbabirye@musph.ac.ug
    • Contact: Esther Buregyeya, PhD; Phone Number: +256752420555; Email: eburegyeya@musph.ac.ug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Child-carer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Household; Household carer-child pairs will be included according to age and consent criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of alcohol use disorder using context adapted CRAFFT screening tool	Period	2020-2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting: Alabama Parenting questionnaire short form (APQ - 15)	The short form includes 15 items scored 0 (never), 1 (almost never), 2 (sometimes), 3 (often), 4 (always) on the five subscales as follows: Involvement (3 qs), Positive Parenting (3 qs), Poor Monitoring/Supervision (3 qs), Inconsistent Discipline (3 qs), Corporal Punishment (3 qs), respectively. No reverse coding necessary when sub-scales reported separately.	2020-2021
Parenting: Conflict Tactic Scale (Original: Straus, 1979, we use: Murray 1995) Version: PARENT-CHILD CONFLICT TACTICS SCALES, FORM CTSPC-CA	Parent score: 0=no, 1=yes Parent form: Min= 0, max= 22 High score indicates high level of conflict and violence. Child score: 0 = it has not happened in the past year; = less than monthly; = monthly; = weekly; =daily Included subscales: Psychological aggression (5 qs), severe assault (4 qs), and very severe assault (4 qs), problems with taking care of child (5 qs) Child form: Min = 0, max = 88 High score indicates high level of conflict and violence.	2020-2021
Child trauma: Child and Adolescent Trauma Screen (CATS)	Scored yes (1) or no (0). 16 questions, yes/no Min: 0 Max: 16 The total score is calculated by adding together the score for each of the items where a higher score indicates more traumatic events.	2020-2021
Adult trauma: Stressful Life Events Screening Questionnaire (SLESQ)	Scored yes (1) or no (0). 14 questions Min: 0 Max 14 The total score is calculated by adding together the score for each of the items where a higher score indicates more stressful live events.	2020-2021
Post traumatic stress disease (PTSD) 2-item checklist	2 questions on clinical and psychological symptoms recorded as: 0=Not at all; A little bit; Moderately; Quite a Bit; Extremely Min-Max: 0-8 A higher score means higher symptom load.	2020-2021
Child mental health: Pediatric symptom checklist (PSC) - child and adolescent version 35 Mental health measures using Pediatric symptom checklist	PSC (Pediatric symptom checklist) 35 questions. It is scored from 2 (often), 1 (sometimes), to 0 (never). Minimum score= 0, maximum score = 70 The total score is calculated by adding together the score for each of the items where a higher score indicates more impairment.	2020-2021
Carer mental health: Self Reporting questionnaire (SRQ) Mental health measures using Pediatric symptom checklist - child version	20 questions. Scored yes (1) or no (0). The total score is calculated by adding together the score for each of the items where a higher score indicates more symptoms of mental illness. Min: 0, max: 20	2020-2021
Carer substance use: The alcohol use disorder identification test (AUDIT)	10 questions, most reported as increasing frequency. The higher score the more vulnerability to having an alcohol drinking problem. Min: 0, max: 20	2020-2021
Dietary diversity- 24 hour recall, food categories as specified by food and agriculture organization 2010 (ISBN 978-92-5-106749-9)	A higher score means higher diversity	2020-2021
Food frequency questionnaire	the most common food items captured as: 0 = No/never,; = Yes, less than weekly; = 1-3 times/week; = 4-6 time/week; = daily A higher score means a richer, more diversified diet	2020-2021
Household food security-HIFAS	6 questions on food security recorded as: 0 = No/never; = Seldom/rare: less than once per month; = Sometimes: 1-2 days last month; = Often: 3-10 days/month; = Very often/usually: more than 10 days last month A higher score means higher household food insecurity.	2020-2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other substance use - sections from Global School Based Health surveys	Not a scale, individual questions measuring frequency and number of units used, measured in days per month and units per month.	2020-2021
Height, in cm, 0.1 nearest cm	Continuous	2020-2021
Weight, in kg, 0.1 nearest kg	Continuous	2020-21
Mid upper arm circumference, cm 0.1 nearest cm	Continuous	2020-21
Urine Etg	Contionuous	2020-21
Standard U-stix: U-blood, protein, glucose, ketones, nitritt, leukocytes, Ph	Qualitative reading, positive or negative	2020-21

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Norwegian University of Science and Technology; The Research Council of Norway; Makerere University
• Investigators: Study Chair: Guri Rørtveit, PhD, Leader

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• University home page

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2020
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Nutrition Disorders; Alcohol Drinking; Alcoholism; Mental Disorders; Malnutrition; Neurodevelopmental Disorders; Child Nutrition Disorders
• Other Study ID Numbers: RCN project no 285489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on consent for sharing by study participants

Study Data/Documents

1. Study Protocol
   Information identifier: 285489
   Information comments: IPD will be shared on reasonable request and the official DMP is archived with NFR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No