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Addiction Disorders in Adolescence- Underlying Pathomechanisms and Treatment Evaluation

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ClinicalTrials.gov Identifier: NCT03444974
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 26, 2018
Last Update Posted Date August 15, 2018
Estimated Study Start Date  ICMJE August 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Sociodemographic data- Highest Education [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about highest education. Measured in options primary school/ currently in high school/ dropped out of school/ finished compulsory school/ finished apprenticeship/ currently doing apprenticeship
  • Sociodemographic data- Gender [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about gender. Measured in options female/ male /other (asks for specification)
  • Sociodemographic data- Migration background [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about migration background. Measured in options no/ yes (asks for specification)
  • Sociodemographic data- Civil status [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about the relationship status. Measured in options single/ married/ separated/ divorced/ widowed/ civil union/ domestic partnership/ other (asks for specification)
  • Sociodemographic data- Nationality [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about nationality. Measured in options German/ other (asks for specification)
  • Sociodemographic data- Age [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about age. Measured in years.
  • Parental report of emotional, behavioral and social problems- Child Behavior Checklist [ Time Frame: Baseline data collection ]
    Emotional, behavioral and social problems associated with adolescents with substance abuse and dependency: Data collection of existence of emotional/behavioral/social problems with help of the Child Behavior Checklist (CBCL). Measured in a person's scoring on 8 different scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior) as well as a total score.
  • Self-report of emotional, behavioral and social problems- Youth Self-Report [ Time Frame: Baseline data collection ]
    Emotional, behavioral and social problems associated with adolescents with substance abuse and dependency: Data collection of existence of emotional/behavioral/social problems with help of the Youth Self-Report (YSR). Measured in a person's scoring on 8 different scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior) as well as a total score.
  • Psychiatric comorbidities- Satisfaction With Life Scale [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Satisfaction With Life Scale (SWLS). The scale is designed to measure global cognitive judgments of one's life satisfaction with help of 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Scoring benchmarks: extremely dissatisfied (5-9), dissatisfied (10-14), slightly dissatisfied (15-19), neutral (20), slightly satisfied (21-25), satisfied (26-30), extremely satisfied (31-35).
  • Psychiatric comorbidities- Beck Depression Inventory [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Beck Depression Inventory (BDI-II). Measured in a test persons's scoring number on the scale.
  • Mental distress- Brief Symptom Checklist [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Brief Symptom Checklist (BSCL). Current amount of mental distress is measured in a person's numerical global severity index.
  • Psychiatric comorbidities- MINI-Kid [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid), a structured diagnostic interview. Measured in positive or negative answers.
  • Molecular and epigenetic changes visible in cortisol [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Measuring cortisol in a single hair sample. Measured in ng/ml.
  • Molecular and epigenetic changes visible in methylation pattern [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Measuring methylation pattern in a single blood sample. Measured in %.
  • Molecular and epigenetic changes visible in immune markers [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Investigating immune marker Interleukin-6 in a single blood sample. Measured in ng/ml.
  • Short term therapy efficacy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Evaluation of therapy efficiency based on existing/non-existing relapse until 3 months after therapy with help of either positive/negative drug screenings.
  • Long term therapy efficacy [ Time Frame: Data collection at 2 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Evaluation of therapy efficiency based on existing/non-existing relapse until 6 months after therapy with help of either positive/negative drug screenings.
  • Change from baseline DUDIT score at 3 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Evaluation of therapy efficiency via Drug Use Disorders Identification Test (DUDIT). Change from baseline DUDIT score at 3 months after therapy is being assessed. Measured in a test persons's scoring number on the DUDIT scale.
  • Change from baseline DUDIT addiction score at 6 months after therapy [ Time Frame: Data collection at 3 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Evaluation of therapy efficiency via DUDIT. Change from baseline DUDIT score at 6 months after therapy is being assessed. Measured in a test persons's scoring number on the DUDIT scale.
  • Change from baseline parenting skills at 3 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a parental test person has completed therapy ]
    Data collection of parenting skills (communication skills) via descriptive self-reports. Change from baseline parenting skills at 3 months after therapy is being assessed. Measured in self-reported description of change.
  • Change from baseline parenting skills at 6 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 6 months after a parental test person has completed therapy ]
    Data collection of parenting skills (communication skills) via descriptive self-reports. Change from from baseline parenting skills at 6 months after therapy is being assessed. Measured in self-reported description of change.
  • Change from baseline parental stress level at 3 months after therapy- Parent Stress Scale [ Time Frame: Data collections at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Data collection of change from baseline parent stress level at 3 months is being assessed via a German questionnaire assessing the amount of parental stress (ESF). Stress factors within everyday parent life are being measured with help of 38 items, which are being scored on a 4-point scale that ranges from 0(disagree) to 3 (completely agree). All items can be assigned to 4 different areas of stress, being social support (7 items, total score 0-21 points), workload and restrictions (7 items, total score 0-21 points), social support (7 items, total score 0-21 points) and cooperative partnership (7 items, total score 0-21). High scores report high stress levels.
  • Change from baseline parental stress level at 6 months after therapy- Parent Stress Scale [ Time Frame: Data collections at 2 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Data collection of change from baseline parent stress level at 6 months is being assessed via a German questionnaire assessing the amount of parental stress (ESF). Stress factors within everyday parent life are being measured with help of 38 items, which are being scored on a 4-point scale that ranges from 0(disagree) to 3 (completely agree). All items can be assigned to 4 different areas of stress, being social support (7 items, total score 0-21 points), workload and restrictions (7 items, total score 0-21 points), social support (7 items, total score 0-21 points) and cooperative partnership (7 items, total score 0-21). High scores report high stress levels.
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
  • Sociodemographic data- Highest Education [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about highest education. Measured in options primary school/ currently in high school/ dropped out of school/ finished compulsory school/ finished apprenticeship/ currently doing apprenticeship
  • Sociodemographic data- Gender [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about gender. Measured in options female/ male /other (asks for specification)
  • Sociodemographic data- Migration background [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about migration background. Measured in options no/ yes (asks for specification)
  • Sociodemographic data- Civil status [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about the relationship status. Measured in options single/ married/ separated/ divorced/ widowed/ civil union/ domestic partnership/ other (asks for specification)
  • Sociodemographic data- Nationality [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about nationality. Measured in options German/ other (asks for specification)
  • Sociodemographic data- Age [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about age. Measured in years.
  • Parental report of emotional, behavioral and social problems- Child Behavior Checklist [ Time Frame: Baseline data collection ]
    Emotional, behavioral and social problems associated with adolescents with substance abuse and dependency: Data collection of existence of emotional/behavioral/social problems with help of the Child Behavior Checklist (CBCL). Measured in a person's scoring on 8 different scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior) as well as a total score.
  • Self-report of emotional, behavioral and social problems- Youth Self-Report [ Time Frame: Baseline data collection ]
    Emotional, behavioral and social problems associated with adolescents with substance abuse and dependency: Data collection of existence of emotional/behavioral/social problems with help of the Youth Self-Report (YSR). Measured in a person's scoring on 8 different scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior) as well as a total score.
  • Psychiatric comorbidities- Satisfaction With Life [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Satisfaction With Life Scale (SWLS). Measured in a test persons's scoring number on the scale.
  • Psychiatric comorbidities- Beck Depression Inventory [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Beck Depression Inventory (BDI-II). Measured in a test persons's scoring number on the scale.
  • Mental distress- Brief Symptom Checklist [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Brief Symptom Checklist (BSCL). Current amount of mental distress is measured in a person's numerical global severity index.
  • Psychiatric comorbidities- MINI-Kid [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid), a structured diagnostic interview. Measured in positive or negative answers.
  • Molecular and epigenetic changes visible in cortisol [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Measuring cortisol in a single hair sample. Measured in ng/ml.
  • Molecular and epigenetic changes visible in methylation pattern [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Measuring methylation pattern in a single blood sample. Measured in %.
  • Molecular and epigenetic changes visible in immune markers [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Investigating immune marker Interleukin-6 in a single blood sample. Measured in ng/ml.
  • Short term therapy efficacy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Evaluation of therapy efficiency based on existing/non-existing relapse until 3 months after therapy with help of either positive/negative drug screenings.
  • Long term therapy efficacy [ Time Frame: Data collection at 2 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Evaluation of therapy efficiency based on existing/non-existing relapse until 6 months after therapy with help of either positive/negative drug screenings.
  • Change from baseline DUDIT score at 3 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Evaluation of therapy efficiency via Drug Use Disorders Identification Test (DUDIT). Change from baseline DUDIT score at 3 months after therapy is being assessed. Measured in a test persons's scoring number on the DUDIT scale.
  • Change from baseline DUDIT addiction score at 6 months after therapy [ Time Frame: Data collection at 3 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Evaluation of therapy efficiency via DUDIT. Change from baseline DUDIT score at 6 months after therapy is being assessed. Measured in a test persons's scoring number on the DUDIT scale.
  • Change from baseline parenting skills at 3 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a parental test person has completed therapy ]
    Data collection of parenting skills (communication skills) via descriptive self-reports. Change from baseline parenting skills at 3 months after therapy is being assessed. Measured in self-reported description of change.
  • Change from baseline parenting skills at 6 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 6 months after a parental test person has completed therapy ]
    Data collection of parenting skills (communication skills) via descriptive self-reports. Change from from baseline parenting skills at 6 months after therapy is being assessed. Measured in self-reported description of change.
  • Change from baseline parental stress level at 3 months after therapy [ Time Frame: Data collections at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Data collection of change from baseline parental stress level at 3 months is being assessed via a German questionnaire assessing parental stress level (ESF). Measured in scale value.
  • Change from baseline parental stress level at 6 months after therapy [ Time Frame: Data collections at 2 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Data collection of change from baseline parental stress level at 6 months is being assessed via ESF (Questionnaire assessing parental stress level). Measured in scale value.
Change History Complete list of historical versions of study NCT03444974 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Addiction Disorders in Adolescence- Underlying Pathomechanisms and Treatment Evaluation
Official Title  ICMJE Addiction Disorders in Adolescence- Underlying Pathomechanisms and Treatment Evaluation
Brief Summary

This study aims to investigate sociodemographic background of youth drug abuse, as well as psychiatric comorbidities with the help of self-report questionnaires and structured diagnostic interviews. The study simultaneously intends to evaluate long term cortisol levels in a single hair sample. Furthermore, three intravenous blood samples will be obtained from each participant in the course of the treatment in order to investigate substance related changes in immune and stress Systems, as well as methylation based changes associated with vulnerability and dependency.

As the efficacy of currently available treatment options for addiction disorders is still unacceptably low, our study also aims to adapt, apply and evaluate new methods of treatment, such as a an adapted short term Matrix therapy for adolescents suffering from addiction disorders and their parents. Therapy outcomes, parental stress levels and learned skills will be evaluated.

Detailed Description

As numbers of youth drug abuse have grown rapidly within the last couple of years, research on youth drug abuse and dependency has taken a new and vital role within the public healthcare system. For this reason, it is crucial to find new ways to effectively integrate adolescent patients into the health care system, as well as assign them to treatment options tailor made for the specific challenges and needs of this population. This study aims to investigate (a) sociodemographic background and psychiatric comorbidities in connection with youth drug abuse and dependency to enhance understanding of epidemiologic risk factors for developing drug dependency in adolescence, as well as benefit future treatment options. It further aims to investigate (b) molecular and epigenetic mechanisms of addiction disorders in adolescents by analyzing methylation pattern, as well as proteome analysis of peripheral immune markers. The investigator's aim is a better understanding of the multimodal biological underpinnings of risk/resilience for addiction in youth on the molecular, cellular and circuit levels with a special focus on the changes within the stress and immune system in patients with addiction disorders and their family members.

Another research interest of this study concerns (c) adapting and evaluating new treatment options, tailor made for the adolescent population. For this reason the investigators aim to adapt, implement and evaluate a therapeutic program according to the Matrix model for the treatment of substance abuse, which consists of two group therapies for patients, as well as their parents (Evaluation time points: T0, T1, T2 and T3). Last, this study aims to (d) evaluate parental stress levels, parental communication skills and knowledge in connection with youth drug abuse.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Symptom reduction in the treatment group (adolescent patients with substance abuse and dependency) in comparison to age and gender matched waiting-list and healthy controls. Changes in stress levels, problem solving and communication skills of parents in the treatment group in comparison to waiting-list parents.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Drug Abuse and Dependency
  • Adolescent Behavior
Intervention  ICMJE Other: adapted treatment according to the Matrix therapy
cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters
Study Arms
  • Active Comparator: Patient therapy group
    • Adolescents with drug abuse and dependency problems
    • Receiving an adapted treatment according to the Matrix therapy
    Intervention: Other: adapted treatment according to the Matrix therapy
  • Active Comparator: Parental therapy group
    • Parents of adolescents with drug abuse problems
    • Receiving an adapted treatment according to the Matrix therapy
    Intervention: Other: adapted treatment according to the Matrix therapy
  • No Intervention: Patient waiting list group
    • Adolescents with drug abuse and dependency problems
    • On the waiting list for receiving a Matrix therapy treatment
  • No Intervention: Parental waiting list group
    • Parents of adolescents with drug abuse problems
    • On the waiting list for receiving a Matrix therapy treatment
  • No Intervention: control group
    • Adolescents with no history of or current drug abuse or dependency
    • no other intake of psychotropic substances such as psychotropic medication
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2018)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Matrix therapy group and waiting list patients:

Inclusion Criteria:

  • continuous substance abuse for at least 6 months or more (at one point in life)
  • Age 12,00-17,11

Exclusion Criteria:

  • Preexisting neurological diseases
  • Diseases of or with involvement of the central nervous system
  • Intelligence quotient (IQ) < 70
  • Diseases concerning the adrenal gland, pituitary gland or hypothalamus
  • Acute viral diseases during T0, T1, T2, T3

Control group:

Inclusion Criteria:

  • Age 12,00-17,11
  • No history of substance abuse

Exclusion Criteria:

  • Preexisting neurological diseases
  • Psychiatric disorders
  • Diseases of or with involvement of the central nervous system (CNS)
  • CNS modulating drug intake
  • IQ < 70
  • Substance abuse
  • Diseases concerning the adrenal gland, pituitary gland or hypothalamus
  • Acute viral diseases during T0, T1, T2, T3
  • psychotropic drug intake

Parental therapy group and waiting list group:

Inclusion Criteria:

  • At least one child/protégé with problematic substance abuse
  • No current substance abuse on their own
  • at least one parent must be eligible to participate in the group

Exclusion Criteria:

  • current drug abuse
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Lisa Klamert, MSc. +49 (0)351 458-7601 lisa.klamert@uniklinikum-dresden.de
Contact: Yulia Golub, Dr.rer.nat. +49 (0)351 458-7601 yulia.golub@uniklinikum-dresden.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03444974
Other Study ID Numbers  ICMJE Matrix_UKD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Veit Roessner, Prof.Dr.med. Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden
PRS Account Technische Universität Dresden
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP