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

Alcohol Use Disorder Clinical Trial

— TREAT C-AUD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743024
• Other study ID #: RCN project no 285489
• Status: Recruiting
• Start date: December 27, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: December 2023
• Source: University of Bergen
• Contact: Ingunn MS Engebretsen, PhD
• Phone: +4755588553
• Email: ingunn.engebretsen[@]uib.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7188
• Est. completion date: July 31, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Child Abuse
• Child Malnutrition
• Child Mental Disorder
• Child Neglect
• Child Nutrition Disorders
• Child, Only
• Malnutrition
• Mental Disorders
• Neurodevelopmental Disorders

Locations

Country	Name	City	State
Uganda	School of Public Health, Makerere University	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
University of Bergen	Makerere University, Norwegian University of Science and Technology, The Research Council of Norway

Country where clinical trial is conducted

Uganda, 

References & Publications (3)

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 — View 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 — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Height, in cm, 0.1 nearest cm	Continuous	2020-2021
Other	Weight, in kg, 0.1 nearest kg	Continuous	2020-21
Other	Mid upper arm circumference, cm 0.1 nearest cm	Continuous	2020-21
Other	Urine Etg	Contionuous	2020-21
Other	Standard U-stix: U-blood, protein, glucose, ketones, nitritt, leukocytes, Ph	Qualitative reading, positive or negative	2020-21
Primary	Prevalence of alcohol use disorder using context adapted CRAFFT screening tool	Period	2020-2021
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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