Trial document




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  DRKS00014042

Trial Description

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Title

Prevention of Alcohol and Tabacco Consumption Using Interventions Based on Mindfulness in Boys with Mild to Borderline Intellectual Disabilities (MBID)

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Trial Acronym

IMAC-Mind_TP5

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URL of the Trial

[---]*

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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).

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Publication of the individual participant data ist not planned. individual case decision possible on request

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Organizational Data

  •   DRKS00014042
  •   2018/03/19
  •   [---]*
  •   yes
  •   Approved
  •   A 2018-0002, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

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Health Condition or Problem studied

  •   DROGENPREVENTION
  •   Prevention of alcohol and tobacco consumption
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Interventions/Observational Groups

  •   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.
  •   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.
  •   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.

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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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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.

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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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/04/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   11   Years
  •   17   Years
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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

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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

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Addresses

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    • Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter
    • Mr.  PD Dr.  Olaf  Reis 
    • Gehlsheimer Straße 20
    • 18147  Rostock
    • Germany
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    • Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter
    • Ms.  Lucie  Waedel 
    • Gehlsheimer Straße 20
    • 18147  Rostock
    • Germany
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    • Universitätsmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter
    • Ms.  Lucie  Waedel 
    • Gehlsheimer Straße 20
    • 18147  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.