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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04743024
Other study ID # RCN project no 285489
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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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