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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743024
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : February 26, 2021
Sponsor:
Collaborators:
The Research Council of Norway
Makerere University
Norwegian University of Science and Technology
Information provided by (Responsible Party):
University of Bergen

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.

Condition or disease
Alcohol Abuse Alcohol Drinking Alcoholism Alcohol Use Disorder Alcohol Dependence Child Abuse Child Malnutrition Child Neglect Child Mental Disorder Child, Only

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.

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Study Type : Observational
Estimated 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 : December 27, 2020
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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



Primary Outcome Measures :
  1. Prevalence of alcohol use disorder using context adapted CRAFFT screening tool [ Time Frame: 2020-2021 ]
    Period


Secondary Outcome Measures :
  1. Parenting: Alabama Parenting questionnaire short form (APQ - 15) [ Time Frame: 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 [ Time Frame: 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

    1. = less than monthly
    2. = monthly
    3. = weekly
    4. =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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 2020-2021 ]

    2 questions on clinical and psychological symptoms recorded as: 0=Not at all

    1. A little bit
    2. Moderately
    3. Quite a Bit
    4. 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 2020-2021 ]
    A higher score means higher diversity

  10. Food frequency questionnaire [ Time Frame: 2020-2021 ]

    the most common food items captured as: 0 = No/never,

    1. = Yes, less than weekly
    2. = 1-3 times/week
    3. = 4-6 time/week
    4. = daily A higher score means a richer, more diversified diet

  11. Household food security-HIFAS [ Time Frame: 2020-2021 ]

    6 questions on food security recorded as: 0 = No/never

    1. = Seldom/rare: less than once per month
    2. = Sometimes: 1-2 days last month
    3. = Often: 3-10 days/month
    4. = 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 [ Time Frame: 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 [ Time Frame: 2020-2021 ]
    Continuous

  3. Weight, in kg, 0.1 nearest kg [ Time Frame: 2020-21 ]
    Continuous

  4. Mid upper arm circumference, cm 0.1 nearest cm [ Time Frame: 2020-21 ]
    Continuous

  5. Urine Etg [ Time Frame: 2020-21 ]
    Contionuous

  6. Standard U-stix: U-blood, protein, glucose, ketones, nitritt, leukocytes, Ph [ Time Frame: 2020-21 ]
    Qualitative reading, positive or negative


Biospecimen Retention:   Samples Without DNA
Urine from 3500 children 3500 carer-child pairs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Child-carer
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743024


Contacts
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Contact: Ingunn MS Engebretsen, PhD +4755588553 ext +4755588553 ingunn.engebretsen@uib.no
Contact: Anne-Berit Kolmanskolg, Ms +47 55 58 54 39 Anne.Kolmannskog@uib.no

Locations
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Uganda
School of Public Health, Makerere University Recruiting
Kampala, Uganda
Contact: Juliet N Babirye, PhD    +256790214320    jnbabirye@musph.ac.ug   
Contact: Esther Buregyeya, PhD    +256752420555    eburegyeya@musph.ac.ug   
Sponsors and Collaborators
University of Bergen
The Research Council of Norway
Makerere University
Norwegian University of Science and Technology
Investigators
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Study Chair: Guri Rørtveit, PhD Leader
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 285489
IPD will be shared on reasonable request and the official DMP is archived with NFR

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT04743024    
Other Study ID Numbers: RCN project no 285489
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Depending on consent for sharing by study participants

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Disease
Alcoholism
Alcohol Drinking
Mental Disorders
Neurodevelopmental Disorders
Pathologic Processes
Nutrition Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders