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

Sponsor
University of Bergen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04743024
Collaborator
The Research Council of Norway (Other), Makerere University (Other), Norwegian University of Science and Technology (Other)
7,000
1
43.1
162.4

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
7000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda: Screening, Diagnostics, Risk Factors and Handling of Children Drinking Alcohol
Actual Study Start Date :
Dec 27, 2020
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Household

Household carer-child pairs will be included according to age and consent criteria

Outcome Measures

Primary Outcome Measures

  1. Prevalence of alcohol use disorder using context adapted CRAFFT screening tool [2020-2021]

    Period

Secondary Outcome Measures

  1. Parenting: Alabama Parenting questionnaire short form (APQ - 15) [2020-2021]

    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.

  2. Parenting: Conflict Tactic Scale (Original: Straus, 1979, we use: Murray 1995) Version: PARENT-CHILD CONFLICT TACTICS SCALES, FORM CTSPC-CA [2020-2021]

    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.

  3. Child trauma: Child and Adolescent Trauma Screen (CATS) [2020-2021]

    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.

  4. Adult trauma: Stressful Life Events Screening Questionnaire (SLESQ) [2020-2021]

    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.

  5. Post traumatic stress disease (PTSD) 2-item checklist [2020-2021]

    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.

  6. Child mental health: Pediatric symptom checklist (PSC) - child and adolescent version 35 Mental health measures using Pediatric symptom checklist [2020-2021]

    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.

  7. Carer mental health: Self Reporting questionnaire (SRQ) Mental health measures using Pediatric symptom checklist - child version [2020-2021]

    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

  8. Carer substance use: The alcohol use disorder identification test (AUDIT) [2020-2021]

    10 questions, most reported as increasing frequency. The higher score the more vulnerability to having an alcohol drinking problem. Min: 0, max: 20

  9. Dietary diversity- 24 hour recall, food categories as specified by food and agriculture organization 2010 (ISBN 978-92-5-106749-9) [2020-2021]

    A higher score means higher diversity

  10. Food frequency questionnaire [2020-2021]

    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

  11. Household food security-HIFAS [2020-2021]

    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.

Other Outcome Measures

  1. Other substance use - sections from Global School Based Health surveys [2020-2021]

    Not a scale, individual questions measuring frequency and number of units used, measured in days per month and units per month.

  2. Height, in cm, 0.1 nearest cm [2020-2021]

    Continuous

  3. Weight, in kg, 0.1 nearest kg [2020-21]

    Continuous

  4. Mid upper arm circumference, cm 0.1 nearest cm [2020-21]

    Continuous

  5. Urine Etg [2020-21]

    Contionuous

  6. Standard U-stix: U-blood, protein, glucose, ketones, nitritt, leukocytes, Ph [2020-21]

    Qualitative reading, positive or negative

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Public Health, Makerere University Kampala Uganda

Sponsors and Collaborators

  • University of Bergen
  • The Research Council of Norway
  • Makerere University
  • Norwegian University of Science and Technology

Investigators

  • Study Chair: Guri Rørtveit, PhD, Leader

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Bergen
ClinicalTrials.gov Identifier:
NCT04743024
Other Study ID Numbers:
  • RCN project no 285489
First Posted:
Feb 8, 2021
Last Update Posted:
Feb 26, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2021