Outpatient follow-up program for adolescents with acute alcohol intoxication

ISRCTN	ISRCTN15542211
DOI	https://doi.org/10.1186/ISRCTN15542211
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Project ID 5149 (ethics committee Antwerp University Hospital) and study number 230101ACADEM (ethics committee ZAS hospital Antwerp)
Sponsor	University of Antwerp
Funder	Universiteit Antwerpen

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mrs Hanna van Roozendaal
Public, Scientific

Universiteitsplein 1
Wilrijk
2610
Belgium

ORCID ID	0000-0001-7599-4503
Phone	+32 (0)3 265 41 11
Email	hanna.vanroozendaal@uantwerpen.be

Prof Guido Van Hal
Principal investigator

Universiteitsplein 1
2610
2610
Belgium

ORCID ID	0000-0002-4611-4076
Phone	+32 (0)3 265 41 11
Email	guido.vanhal@uantwerpen.be

Study information

Primary study design	Interventional
Study design	Multicenter interventional non-randomized quasi-experimental trial
Secondary study design	Non randomised study
Study type	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(s)	Alcohol use measured with the AUDIT-C score at T0 and T2
Key secondary outcome measure(s)	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
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	All
Target sample size at registration	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

Antwerp University Hospital

Drie Eikenstraat 655
Edegem
2650
Belgium

ZAS Augustinus

Oosterveldlaan 24
Wilrijk
2610
Belgium

ZAS Vincentius

Sint-Vincentiusstraat 20
Antwerp
2018
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/04/2025: Study's existence confirmed by the Central Ethical Committee of The Antwerp University Hospital.