Alcohol AbuseTREAT C-AUDNCT04743024
TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda
An observational study of Alcohol Abuse and Alcohol Drinking, run by University of Bergen at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Alcohol Drinking, Alcoholism
- How many people
- 7,188 participants
- Where
- 1 siteUganda
- Study dates
- 27 Dec 2020to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Child-carer
Who may be able to join
- 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
Who cannot join
- Caregiver or child not living in household
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
School of Public Health, Makerere University
Kampala
Juliet N Babirye, PhD, +256790214320, jnbabirye@musph.ac.ug
Esther Buregyeya, PhD, +256752420555, eburegyeya@musph.ac.ug
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Abuse, Alcohol Drinking, Alcoholism, Alcohol Use Disorder, Alcohol Dependence, Child Abuse
- Medical subject headings
- Alcoholism, Alcohol Drinking, Child Nutrition Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Household | Household carer-child pairs will be included according to age and consent criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of alcohol use disorder using context adapted CRAFFT screening tool
Period
Measured: 2020-2021
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start27 Dec 2020
- Primary completion15 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 7,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Makerere University, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Guri Rørtveit, PhD, Study chair, Leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743024
- Sponsor's protocol ID
- RCN project no 285489
- Acronym
- TREAT C-AUD
- Status last verified
- Dec 2023
- First submitted
- 11 Nov 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on consent for sharing by study participants
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.
PubMed 33110445Akol 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.
PubMed 30455964Akol 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.
PubMed 28855962Skylstad 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.
PubMed 34345718
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda: Screening, Diagnostics, Risk Factors and Handling of Children Drinking Alcohol
- ClinicalTrials.gov ID
- NCT04743024
- Acronym / sponsor ID
- TREAT C-AUD / RCN project no 285489
- Conditions
- Alcohol Abuse, Alcohol Drinking, Alcoholism, Alcohol Use Disorder, Alcohol Dependence, Child Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,188 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Makerere University, Norwegian University of Science and Technology
- Study start
- 27 Dec 2020 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Household | – | –Household carer-child pairs will be included according to age and consent criteria |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Child-carer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Caregiver or child not living in household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of alcohol use disorder using context adapted CRAFFT screening tool
Time frame: 2020-2021
Period
11 secondary outcomes
Parenting: Alabama Parenting questionnaire short form (APQ - 15)
Time frame: 2020-2021
Parenting: Conflict Tactic Scale (Original: Straus, 1979, we use: Murray 1995) Version: PARENT-CHILD CONFLICT TACTICS SCALES, FORM CTSPC-CA
Time frame: 2020-2021
Child trauma: Child and Adolescent Trauma Screen (CATS)
Time frame: 2020-2021
Adult trauma: Stressful Life Events Screening Questionnaire (SLESQ)
Time frame: 2020-2021
Post traumatic stress disease (PTSD) 2-item checklist
Time frame: 2020-2021
Child mental health: Pediatric symptom checklist (PSC) - child and adolescent version 35 Mental health measures using Pediatric symptom checklist
Time frame: 2020-2021
Carer mental health: Self Reporting questionnaire (SRQ) Mental health measures using Pediatric symptom checklist - child version
Time frame: 2020-2021
Carer substance use: The alcohol use disorder identification test (AUDIT)
Time frame: 2020-2021
Dietary diversity- 24 hour recall, food categories as specified by food and agriculture organization 2010 (ISBN 978-92-5-106749-9)
Time frame: 2020-2021
Food frequency questionnaire
Time frame: 2020-2021
Household food security-HIFAS
Time frame: 2020-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 33110445Engebretsen 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.
- Results publication: PubMed 30455964Akol 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.
- Results publication: PubMed 28855962Akol 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.
- Derived from this study: PubMed 34345718Skylstad 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.
- University home pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Depending on consent for sharing by study participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guri Rørtveit, PhD study chair
Leader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Abuse and Alcohol Drinking, run by University of Bergen at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingunn MS Engebretsen, PhD (+4755588553 ext. +4755588553, ingunn.engebretsen@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of alcohol use disorder using context adapted CRAFFT screening tool (time frame: 2020-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743024, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.