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
|Condition or disease|
|Alcohol Abuse Alcohol Drinking Alcoholism Alcohol Use Disorder Alcohol Dependence Child Abuse Child Malnutrition Child Neglect Child Mental Disorder Child, Only|
|Study Type :||Observational|
|Estimated Enrollment :||7000 participants|
|Observational Model:||Ecologic or Community|
|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|
Household carer-child pairs will be included according to age and consent criteria
- Prevalence of alcohol use disorder using context adapted CRAFFT screening tool [ Time Frame: 2020-2021 ]Period
- 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.
- 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.
0 = it has not happened in the past year
- = less than monthly
- = monthly
- = weekly
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.
- 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.
- 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.
- 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
- A little bit
- Quite a Bit
- Extremely Min-Max: 0-8 A higher score means higher symptom load.
- 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.
- 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
- 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
- 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
- Food frequency questionnaire [ Time Frame: 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
- Household food security-HIFAS [ Time Frame: 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 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.
- Height, in cm, 0.1 nearest cm [ Time Frame: 2020-2021 ]Continuous
- Weight, in kg, 0.1 nearest kg [ Time Frame: 2020-21 ]Continuous
- Mid upper arm circumference, cm 0.1 nearest cm [ Time Frame: 2020-21 ]Continuous
- Urine Etg [ Time Frame: 2020-21 ]Contionuous
- 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
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
|Contact: Ingunn MS Engebretsen, PhD||+4755588553 ext +email@example.com|
|Contact: Anne-Berit Kolmanskolg, Ms||+47 55 58 54 39||Anne.Kolmannskog@uib.no|
|Study Chair:||Guri Rørtveit, PhD||Leader|