NCT04743024

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,188

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 27, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

November 11, 2020

Last Update Submit

December 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of alcohol use disorder using context adapted CRAFFT screening tool

    Period

    2020-2021

Secondary Outcomes (11)

  • Parenting: Alabama Parenting questionnaire short form (APQ - 15)

    2020-2021

  • Parenting: Conflict Tactic Scale (Original: Straus, 1979, we use: Murray 1995) Version: PARENT-CHILD CONFLICT TACTICS SCALES, FORM CTSPC-CA

    2020-2021

  • Child trauma: Child and Adolescent Trauma Screen (CATS)

    2020-2021

  • Adult trauma: Stressful Life Events Screening Questionnaire (SLESQ)

    2020-2021

  • Post traumatic stress disease (PTSD) 2-item checklist

    2020-2021

  • +6 more secondary outcomes

Other Outcomes (6)

  • Other substance use - sections from Global School Based Health surveys

    2020-2021

  • Height, in cm, 0.1 nearest cm

    2020-2021

  • Weight, in kg, 0.1 nearest kg

    2020-21

  • +3 more other outcomes

Study Arms (1)

Household

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

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Child-carer

You may qualify if:

  • 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

You may not qualify if:

  • Caregiver or child not living in household

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, Makerere University

Kampala, Uganda

RECRUITING

Related Publications (4)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine from 3594 children 3594 carer-child pairs

MeSH Terms

Conditions

AlcoholismAlcohol DrinkingChild Nutrition DisordersNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Guri Rørtveit, PhD

    Leader

    STUDY CHAIR

Central Study Contacts

Ingunn MS Engebretsen, PhD

CONTACT

Anne-Berit Kolmanskolg, Ms

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2020

First Posted

February 8, 2021

Study Start

December 27, 2020

Primary Completion

December 15, 2024

Study Completion

July 31, 2025

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations