Substance use prevention in adolescence by the mindfulness-augmented Strengthening Families Program 10-14 („SFP-Mind“)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015678

Enrollment

100

Registered

2019-02-25

Start date

2019-12-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol and other substance use: initiation, quantity and frequency of use, substance abuse comorbid psychological and behavioral symptoms Harmful use of alcohol F10.0 F10.1

Interventions

Group 1: Experimental intervention / index test: Mindfulness-enhanced version of the evidence based substance use prevention program Strengthening Families Program 10-14 (SFP 10–14)

Program will be implemented in 7 weekly sessions. After modification of the study: experimental intervention/ index test: mindfulness-enhanced digital version of the evidence based substance use pre

Program will be implemented in 8 weekly sessions (1 session technical set-up, 7 sessions intervention) Group 2: Control intervention / reference test: Standard program version SFP 10-14 without mindfu

Program will be implemented in 8 weekly sessions (1 session technical set-up, 7 sessions intervention)

Eligibility

Sex/Gender

All

Age

10 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1) at least one adolescent aged 10-14 years and one parent (or other legal guardian) per family willing to participate in the program. 2) informed consent. For "Familien (Achtsam) Stärken Digital": access to the internet, which is compatible for use with internet-based video-conferencing systems.

Exclusion criteria

Exclusion criteria: 1) acute psychotic or suicidal symptoms; 2) insufficient language capability.

Design outcomes

Primary

Measure	Time frame
adolescent alcohol use 18 months after the intervention, based on a self-reportes alcohol initiation index (lifetime prevalence of experimental use, full drink, minimal and severe drunkenness). The assessment of the primary outcome could only be implemented for the first original study on “Familien (Achtsam) Stärken”, which was subsequently halted. An analysis of possible effects on this outcome using this data will be performed in an exploratory fashion only. In the modified version of the study “Familien (Achtsam) Stärken Digital”, an exploratory approach will be followed, a powered hypothesis-testing design could not be pursued further. Data on substance use and other secondary outcomes will be collected before the interventions/ randomization, after the interventions and six months after the beginning of the interventions. Effect sizes for the added effect of the mindfulness-based components of “Familien Achtsam Stärken Digital” will be calculated by contrasting data to the control condition “Familien Stärken Digital”. In the modified version of the study, the feasibility aspect of the interventions is focused by using measures of participant satisfaction, adherence and compliance.	—

Measure

Time frame

adolescent alcohol use 18 months after the intervention, based on a self-reportes alcohol initiation index (lifetime prevalence of experimental use, full drink, minimal and severe drunkenness). The assessment of the primary outcome could only be implemented for the first original study on “Familien (Achtsam) Stärken”, which was subsequently halted. An analysis of possible effects on this outcome using this data will be performed in an exploratory fashion only. In the modified version of the study “Familien (Achtsam) Stärken Digital”, an exploratory approach will be followed, a powered hypothesis-testing design could not be pursued further. Data on substance use and other secondary outcomes will be collected before the interventions/ randomization, after the interventions and six months after the beginning of the interventions. Effect sizes for the added effect of the mindfulness-based components of “Familien Achtsam Stärken Digital” will be calculated by contrasting data to the control condition “Familien Stärken Digital”. In the modified version of the study, the feasibility aspect of the interventions is focused by using measures of participant satisfaction, adherence and compliance.

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Secondary

Measure	Time frame
Adolescents: Frequency and quantity of use of alcohol, tobacco, cannabis and other illegal substances in past 30 days, 18 months after the Intervention. Additionally (post-Intervention, 6 and 18 months after the Intervention): Psychopathological symptoms (Strengths and Difficulties Questionnaire (SDQ)); Quality of Life (Kidscreen 10), trait mindfulness (Mindful Awareness and Attention Scale (MAAS)), Stress (Perceived Stress Scale (PSS-4)), Emotionregulation (Difficulties in emotion regulation scale (DERS)), Reward sensitivity (Monetary Incentive Delay Task), Impulse Control (Stop Signal Task, Delay Discounting, Cambridge Gambling Task, Substance Use Risk Profile Scale, SURPS). Parents: Mindful Parenting Erziehungsverhalten (Interpersonal Mindfulness in Parenting scale (IEM-P), Parental Representation (PRSQ), Family Functioning (Family APGAR), Feasibility of mindfulness intervention components (including intervention integrity and implementation), adverse events (AE). The assessment of the above mentioned secondary data could only be pursued for the first original and later halted part of the study on “Familien (Achtsam) Stärken”. For the modified study (“Familien (Achtsam) Stärken Digital”) the following modifications were implemented: (a) the above mentioned secondary outcomes will be further assessed with the exception of neuropsychological assessments on incentive processing (Monetary Incentive Delay Task) and impulsivity (Stop Signal Task, Delay Discounting, Cambridge Gambling Task). (b) Assessments 18 months after the end of the interventions are dropped. Assessments will be made before the interventions/ randomization, after the interventions and six months after the beginning of the interventions. (c) Assessments on participant satisfaction (modified version of the Fragebogen zur Zufriedenheit mit der Behandlung (FBB)), compliance and adherence were introduced.	—

Measure

Time frame

Adolescents: Frequency and quantity of use of alcohol, tobacco, cannabis and other illegal substances in past 30 days, 18 months after the Intervention. Additionally (post-Intervention, 6 and 18 months after the Intervention): Psychopathological symptoms (Strengths and Difficulties Questionnaire (SDQ)); Quality of Life (Kidscreen 10), trait mindfulness (Mindful Awareness and Attention Scale (MAAS)), Stress (Perceived Stress Scale (PSS-4)), Emotionregulation (Difficulties in emotion regulation scale (DERS)), Reward sensitivity (Monetary Incentive Delay Task), Impulse Control (Stop Signal Task, Delay Discounting, Cambridge Gambling Task, Substance Use Risk Profile Scale, SURPS). Parents: Mindful Parenting Erziehungsverhalten (Interpersonal Mindfulness in Parenting scale (IEM-P), Parental Representation (PRSQ), Family Functioning (Family APGAR), Feasibility of mindfulness intervention components (including intervention integrity and implementation), adverse events (AE). The assessment of the above mentioned secondary data could only be pursued for the first original and later halted part of the study on “Familien (Achtsam) Stärken”. For the modified study (“Familien (Achtsam) Stärken Digital”) the following modifications were implemented: (a) the above mentioned secondary outcomes will be further assessed with the exception of neuropsychological assessments on incentive processing (Monetary Incentive Delay Task) and impulsivity (Stop Signal Task, Delay Discounting, Cambridge Gambling Task). (b) Assessments 18 months after the end of the interventions are dropped. Assessments will be made before the interventions/ randomization, after the interventions and six months after the beginning of the interventions. (c) Assessments on participant satisfaction (modified version of the Fragebogen zur Zufriedenheit mit der Behandlung (FBB)), compliance and adherence were introduced.

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Countries

Germany

Contacts

Public ContactChristiane Baldus-Firnhaber

Universitätsklinikum Hamburg-EppendorfDeutsches Zentrum für Suchtfragen des Kindes- und Jugendalters (DZSKJ)

cbaldus@uke.de040/7410 58402

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 19, 2026