Prevention of Alcohol and Tabacco Consumption Using Interventions Based on Mindfulness in Boys with Mild to Borderline Intellectual Disabilities (MBID)
Organizational Data
- DRKS-ID:
- DRKS00014042
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2018-03-19
- Last update in DRKS:
- 2020-09-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
IMAC-Mind_TP5
URL of the study
No Entry
Brief summary in lay language
Lower cognitive capacities (< IQ 85) affect about 15% of the population and are associated with increased risks of alcohol abuse. Boys with mild to borderline intellectual disability MBID (70 – IQ – 85) comprise a major risk group for alcohol use after they started to drink. Compared to girls with MBID, they report more events of heavy drinking and conflicts with the law. The lower cognitive capacity is a major factor for often impaired emotion regulation and impulsive-disruptive behavior which are also key mechanisms of addictive behavior and are often treated pharmacologically. Non-pharmacological interventions, such as mindfulness-based interventions, offer a promising alter-native, but have not yet been examined for their feasibility. Aims of this study are 1) to adapt, integrate and demonstrate feasibility of mindfulness-based interventions (MBI) for the at-risk group of adolescents with MBID, 2) to provide initial evidence that MBIs postpone initiation, and/or decrease substance use and/or abuse in children and adolescents with MBID, 3) to select and adapt available MBIs to target bio-behavioral factors implicated in adolescent substance use and related malfunctioning (see other projects), 4) to evaluate the role of these targets in improving addiction-related outcomes in adolescents with MBID. In addition, in a 3rd study arm, independent of the RCT, persons of the target group who have no previous experience with alcohol will be followed (amendment approved on 26.05.2020).
Brief summary in scientific language
Adolescents aged 11-17 years with mild or borderline intellectual disability (70 < IQ < 85 or at special schools) who started drinking and smoking should be included to the study if infomed consent from them and parents is available. In phase 1 all exercises in mindfilness (duration, frequency, individual golas) will be developed on about 30 adolescents for feasibility in different setting (individual sessions at home, clinical parctices, school, residential communities). Measurements via SmartPhone App will be adapted. reinforcement strategies (every second participation will be reinforced), feedback-loops, and habituation to training and measurement will be estimated. The measurement of neurobehavioral risk and resilience factors needs to adapted with regards to comprehensibility, attractivity, duration, frequency, sources of error). An active control condition needs to be developed which is equally in intense in attachment, attractiveness, and duration. In phase 2 (proof of concept) intervention and active control should be randomized to two groups of n = 41. Results will be utilized in different ways. If feasibility and positive evidence are given, a clinical trial will be designed and proposed. Three papers on feasibility and evaluation should be published.
Health condition or problem studied
- Free text:
- DROGENPREVENTION
- Free text:
- Prevention of alcohol and tobacco consumption
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Experimental intervention: After demonstrating the feasibility of mindfulness-based interventions (MBI) for the at-risk group of adolescents with Mild to Borderline Intellectual Disabilities (MBID) we will investigate the change in alcohol and tobacco use. The experimental intervention is addressed to the needs of adolescent boys (n=41) with MBID who started drinking alcohol prior to the intervention. The intervention includes mindfulness-based training and drug prevention education. An estimated intervention period of 6 training sessions (once per week) is assumed. Pre-and post-intervention assessment of neurocognitive markers is scheduled using a PC Test battery. Weekly surveys via App recording the quantity of substance use will be implemented during a 12-month follow-up phase.
- Arm 2:
- Control intervention: The active control intervention is addressed to the needs of adolescent boys (n=41) with MBID who started drinking alcohol prior to the intervention. The control intervention includes drug prevention and health education without mindfulness-based training. An estimated intervention period of 6 training sessions (once per week) is assumed. Pre-and post-intervention assessment of neurocognitive markers is scheduled using a PC Test battery. Weekly App surveys recording the quantity of substance use will be implemented during a 12-month follow-up phase.
- Arm 3:
- Outside the RCT: N=38 male adolescents with mild to borderline intellectual disabilities who give their consent to participate but do not meet the inclusion criterion "alcohol drinking in the last 12 months". These subjects are not randomized. They run parallel to the RCT and are not treated. This approach is intended to provide explorative data on prevalence, i.e. on the start of substance use in the target group. These participants also undergo pre-, post- and follow-up measurements.
Endpoints
- Primary outcome:
- Primary efficacy endpoint: Duration between training and events of drunkenness, frequency/quantity of alcohol use during 12 months after treatment. Primary outcome Alcohol: Comparisons of group differences in survival rates for the event “drunkenness last week” for 12 months after treatment.
- Secondary outcome:
- Secondary endpoints: Substance use data will be correlated with neurobehavioral variables, dispositional mindfulness, and other possible mediating variables (stress, regulation of emotions, mental health, familiy risk factors, influence of peers, personality, intelligence)
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Rostock- Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter Rostock
Recruitment period and number of participants
- Planned study start date:
- 2020-04-01
- Actual study start date:
- 2020-04-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 120
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Male
- Minimum Age:
- 11 Years
- Maximum Age:
- 17 Years
- Additional Inclusion Criteria:
- (1) Adolescent boys (2) Age: 11-17 yrs. (3) MBID (70 ≤ IQ ≤ 85) (4) who report drinking alcohol during the past year (5) informed consent from participants and one parent/legal guardian
Exclusion Criteria
(1) Boys without experiences of drinking (2) severe psychiatric disorders requiring on-site treatment or dependence on alcohol or drugs (3) Profound developmental delays (autism) (4) Severe speech disorder
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und JugendalterPD Dr. Olaf ReisGehlsheimer Straße 2018147 RostockGermany
- Telephone:
- (0381) 49 4- 9856
- Fax:
- (0381) 49 4 – 46 12
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://kjpp.med.uni-rostock.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und JugendalterLucie WaedelGehlsheimer Straße 2018147 RostockGermany
- Telephone:
- (0381) 49 4 – 9518
- Fax:
- (0381) 49 4 – 46 12
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://kjpp.med.uni-rostock.de/
Contact for Public Queries
- Address:
- Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und JugendalterLucie WaedelGehlsheimer Straße 2018147 RostockGermany
- Telephone:
- (0381) 49 4 – 9518
- Fax:
- (0381) 49 4 – 46 12
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://kjpp.med.uni-rostock.de/
Principal Investigator
- Address:
- Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und JugendalterLucie WaedelGehlsheimer Straße 2018147 RostockGermany
- Telephone:
- (0381) 49 4 – 9518
- Fax:
- (0381) 49 4 – 46 12
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://kjpp.med.uni-rostock.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der Medizinischen Fakultät der Universität Rostock im Institut für RechtsmedizinSt.-Georg-Str. 10818055 RostockGermany
- Telephone:
- +49-381-4949904
- Fax:
- +49-381-4949902
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-01-02
- Ethics committee number:
- A 2018-0002
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-01-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Publication of the individual participant data ist not planned. individual case decision possible on request
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry