Outpatient follow-up program for adolescents with acute alcohol intoxication
| ISRCTN | ISRCTN15542211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15542211 |
| Secondary identifying numbers | Project ID 5149 (ethics committee Antwerp University Hospital) and study number 230101ACADEM (ethics committee ZAS hospital Antwerp) |
- Submission date
- 22/04/2025
- Registration date
- 22/04/2025
- Last edited
- 22/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to reduce recurrence, decrease alcohol misuse, detect underlying psychological disorders and improve parent-child interaction among adolescents admitted to hospital with an acute alcohol intoxication in Antwerp, Belgium.
Who can participate?
Adolescents aged 10–17 years who present with acute alcohol intoxication at the emergency, paediatric, or intensive care departments of the hospitals ZAS Augustinus, ZAS Vincentius, or Antwerp University Hospital (UZA) in Antwerp, Belgium, with a clinically diagnosed or laboratory-confirmed alcohol intoxication who have decreased consciousness or an indication for hospitalisation overnight. Patients are recruited at the Antwerp University Hospital, ZAS Augustinus and ZAS Vincentius in Antwerp, Belgium.
What does the study involve?
The participants are offered a 6-month outpatient follow-up program located in ZAS Augustinus, including personalised feedback, motivational interviewing, psychological screening, and parental involvement. It encompasses information materials at the time of discharge, screening consultations with a child psychologist and medical doctor one month after discharce, an advisory consult 1 month later, and a final follow-up consultation with both the child psychologist and medical doctor 6 months after admission, to assess progress and, if necessary, provide a referral.
What are the possible benefits and risks of participating?
No possible risks are expected from participating. Potential benefits are decreased problematic alcohol use and improved parent-child interaction.
Where is the study run from?
Antwerp University Hospital, ZAS Augustinus and ZAS Vincentius in Antwerp (Belgium)
When is the study starting and how long is it expected to run for?
January 2022 to May 2025
Who is funding the study?
University of Antwerp (Belgium)
Who is the main contact?
PhD student Hanna van Roozendaal, hanna.vanroozendaal@uantwerpen.be
Contact information
Public, Scientific
Universiteitsplein 1
Wilrijk
2610
Belgium
 ORCID ID |
0000-0001-7599-4503 |
|---|---|
| Phone | +32 (0)3 265 41 11 |
| hanna.vanroozendaal@uantwerpen.be |
Principal Investigator
Universiteitsplein 1
2610
2610
Belgium
| ORCID ID |
0000-0002-4611-4076 |
|---|---|
| Phone | +32 (0)3 265 41 11 |
| guido.vanhal@uantwerpen.be |
Study information
| Study design | Multicenter interventional non-randomized quasi-experimental trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Outpatient multidisciplinary follow-up program for adolescents with acute alcohol intoxication in Belgium: the SPIRIT pilot study |
| Study acronym | SPIRIT |
| Study objectives | The outpatient follow-up program for adolescents with acute alcohol intoxication will support in reducing the recurrence rate, decreasing problematic alcohol use, detecting underlying psychological disorders and increasing the parent-child interaction. |
| Ethics approval(s) |
1. Approved 20/02/2023, Central Ethical Committee of The Antwerp University Hospital (Drie Eikenstraat 655, Edegem, 2650, Belgium; +32 (0)3 821 38 97; ethisch.comite@uza.be), ref: 5149 2. Approved 07/03/2023, Medical Ethical Committee of ZAS Augustinus (Oosterveldlaan 22, Wilrijk, 2610, Belgium; +32 (0)3 443 38 62; gza.ec@zas.be), ref: 230101ACADEM |
| Health condition(s) or problem(s) studied | Adolescents admitted with acute alcohol intoxication |
| Intervention | The intervention consists of a 6-month outpatient follow-up treatment program for adolescents admitted to hospital, which includes personalised feedback, motivational interviewing, psychological screening, and parental involvement. At discharge (T0), participants and their parents receive a QR code linking to a study-specific website where they fill in questionnaires and can find information materials. Four to six weeks post-discharge (T1), participants and their parents are invited for screening consultations with the child psychologist and medical doctor. Four to six weeks after the T1 consultations, adolescents and their parents attend a second consultation with the psychologist, where advice based on the initial screening is provided. Motivational interviewing and brief cognitive behavioural therapy, when indicated, are used here. Finally, at 6 months post-admission (T2), a final follow-up consultation with both the psychologist and the medical doctor is conducted to assess progress and, if necessary, provide a referral. Participants and parents fill in a follow-up questionnaire at this timepoint. |
| Intervention type | Behavioural |
| Primary outcome measure | Alcohol use measured with the AUDIT-C score at T0 and T2 |
| Secondary outcome measures | 1. Recurrent alcohol intoxications measured via survey at T2 2. Frequency of binge drinking questioned in the T0 and T2 surveys 3. Internalising and externalising problems measured using the Youth Self-Report (YSR) and Child Behavior Checklist (CBCL) at T0 and T2 4. Parental rule setting regarding alcohol use questioned in the T0 and T2 surveys 5. Parent-child interaction measured with the Conflict Behavior Questionnaire (CBQ) at T0 and T2 6. Parenting style measured with the Parenting Scale at T0 and T2 |
| Overall study start date | 01/01/2022 |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient, Other |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 14 |
| Key inclusion criteria | 1. Adolescents aged 10–17 years 2. Present with acute alcohol intoxication (AAI) at the emergency, paediatric, or intensive care departments of the hospitals ZAS Augustinus, ZAS Vincentius, or Antwerp University Hospital (UZA) in Antwerp, Belgium 3. Alcohol intoxication clinically diagnosed or laboratory-confirmed (increased blood alcohol concentration [BAC]) 4. Decreased consciousness (Glasgow Coma Scale [GCS] ≤14) or an indication for hospitalisation overnight |
| Key exclusion criteria | In the case of direct referral for addiction treatment, patients are not included in the study |
| Date of first enrolment | 23/05/2023 |
| Date of final enrolment | 31/03/2025 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Edegem
2650
Belgium
Wilrijk
2610
Belgium
Antwerp
2018
Belgium
Sponsor information
University/education
Universiteitsplein 12
Wilrijk
2610
Belgium
| Phone | +32 (0)3 265 41 11 |
|---|---|
| research@uantwerpen.be | |
| Website | https://www.uantwerpen.be/en/ |
"ROR" |
https://ror.org/008x57b05 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Antwerp, UAntwerp, Universiteit van Antwerpen, Uantwerpen
- Location
- Belgium
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset generated and analysed during the current study will be available upon request from Hanna van Roozendaal (hanna.vanroozendaal@uantwerpen.be) |
Editorial Notes
22/04/2025: Study's existence confirmed by the Central Ethical Committee of The Antwerp University Hospital.
