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Addiction in Adolescence - Pathomechanisms and Treatment Evaluation (MATRIX-A)

Primary Purpose

Substance Use Disorders, Adolescent Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
adapted treatment according to the MATRIX-A therapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring drugs, youth, adolescence, abuse, dependence, Tetrahydrocannabinol (THC), Methamphetamine (Crystal Meth), Marihuana, comorbidity, treatment, etiopathology, sociodemographics, Saxony, MATRIX, Psychotherapy

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Adolescents:

Inclusion Criteria:

  • Age 12.00-17.99
  • Therapy / wait list group: current substance use disorder
  • Controls: no history of substance use disorders

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
  • Controls:

    • Drug intake modulating the central nervous system
    • Main psychiatric disorders
    • Current substance use

Parents:

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 substance abuse

Sites / Locations

  • Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital C.G.CarusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

No Intervention

Arm Label

Patient therapy group

Parental therapy group

Patient waiting list group

Parental waiting list group

control group

Arm Description

Adolescents with substance use disorders Receiving an adapted treatment according to the MATRIX-A therapy

Parents of adolescents with substance use disorders Receiving an adapted treatment according to the MATRIX-A therapy

Adolescents with substance use disorders On the waiting list for receiving a MATRIX-A therapy

Parents of adolescents with substance use disorders On the waiting list for receiving a MATRIX-A therapy

Adolescents with no history of substance use disorders no other intake of psychotropic substances such as psychotropic medication

Outcomes

Primary Outcome Measures

Aim 1: Sociodemographic background
Sociodemographic background of adolescents with substance use disorders via self-constructed items: age (in years) gender (male/female) highest education (primary school/ currently in high school/ dropped out of school/ finished compulsory school/ finished apprenticeship/ currently doing apprenticeship) migration background (no/ yes > asks for specification) nationality (German/ other > asks for specification) relationship status (single/ married/ separated/ divorced/ widowed/ civil union/ domestic partnership/ other > asks for specification)
Aim 2: Psychiatric comorbidities - MINI-KID
Current psychiatric comorbidities according to Diagnostic and Statistic Manual of Mental Disorders, 5th Ed. (DSM-5) assessed via Mini International Neuropsychiatric Interview for Children and Adolescents (MINI KID), a structured diagnostic interview. Single interview questions rated (yes / no). DSM-5 diagnoses for past month (or other if specified) in accordance with MINI-KID scoring algorithms.
Aim 2: Change in substance use
Changes in self-reported substance use between T0, T1, T2. Assessed via quantity and frequency questions for different substance categories.
Aim 3: Changes in biomarkers related to substance use disorders
cumulative stress: hair cortisol levels in a single hair sample. Measured in ng/ml. epigenetic changes: methylation pattern in a single blood sample. Measured in %. immunological changes: immune marker Interleukin-6 in a single blood sample. Measured in ng/ml.
Aim 4: Subjective therapy outcomes
Evaluation of possible therapy effects (e.g. knowledge, relapse prevention skills, emotions/affects, maintenance self-efficacy, motivation, stress tolerance) with 5-point Likert options (not at T0). Substance use disorder severity assessed via Drug Use Disorders Identification Test (DUDIT). Measured in a test persons's scoring number on the DUDIT scale. Change from baseline DUDIT score to T1 and T2 DUDIT scores.
Aim 4: Objective therapy outcomes
- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.
Aim 5: Change in baseline parenting skills
Assessment of parenting skills (communication skills) via descriptive self-reports. Change from T0 to T1. Measured in self-reported description of change.
Aim 5: Change in baseline parental stress reports - ESF
Change from self-reported baseline parent stress level to T1 anjd T2 parental stress levels. 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.

Secondary Outcome Measures

Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)
Emotional, behavioral and social problems associated with adolescents with substance use disorders: 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.
Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)
Emotional, behavioral and social problems associated with adolescents with substance use disorders: 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.
Adolescent depressivity - BDI-II
Psychiatric comorbidities associated with adolescents with substance use disorders: 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
Psychiatric comorbidities associated with adolescents with substance use disorders: 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.
Adolescent satisfaction with life
Psychiatric comorbidities associated with adolescents with substance use disorders: 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).

Full Information

First Posted
February 6, 2018
Last Updated
March 29, 2019
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT03444974
Brief Title
Addiction in Adolescence - Pathomechanisms and Treatment Evaluation
Acronym
MATRIX-A
Official Title
Addiction and Substance Dependence in Adolescence - Neurobiological Pathomechanisms and Treatment Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the sociodemographic background as well as psychiatric comorbidities of adolescent substance users with substance use disorders. The study simultaneously evaluates biomarkers of stress and addiction, including long-term cortisol levels from hair samples and gene methylation in blood samples associated with substance use. Our study also adapts, rolls out, and evaluates an evaluated multimodal treatment manual wich was originally intended for stimulant drug users (MATRIX). We adopt this manual to the needs and specifics of adolescents (MATRIX-A, A=adolescents) with substance use disorders of any substance, including cannabis, methamphetamine, and alcohol. Adolescents will receive group therapy sessions, individual therapy sessions, and medication if needed, while parents or professional caretaker will receive group sessions. Therapy outcomes will be examined in addition to parental distress and parenting skills.
Detailed Description
As numbers of adolescent 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 adolescent substance abuse and dependence 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 manual for the treatment of substance abuse, which consists of two group therapies for patients, as well as their parents (Evaluation time points: T0, T1, and T2). Last, this study aims to (d) evaluate parental stress levels, parental communication skills and knowledge in connection with adolescent substance abuse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Adolescent Behavior
Keywords
drugs, youth, adolescence, abuse, dependence, Tetrahydrocannabinol (THC), Methamphetamine (Crystal Meth), Marihuana, comorbidity, treatment, etiopathology, sociodemographics, Saxony, MATRIX, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 parental stress levels and parenting skills in the treatment group parents in comparison to waiting-list parents.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient therapy group
Arm Type
Active Comparator
Arm Description
Adolescents with substance use disorders Receiving an adapted treatment according to the MATRIX-A therapy
Arm Title
Parental therapy group
Arm Type
Active Comparator
Arm Description
Parents of adolescents with substance use disorders Receiving an adapted treatment according to the MATRIX-A therapy
Arm Title
Patient waiting list group
Arm Type
No Intervention
Arm Description
Adolescents with substance use disorders On the waiting list for receiving a MATRIX-A therapy
Arm Title
Parental waiting list group
Arm Type
No Intervention
Arm Description
Parents of adolescents with substance use disorders On the waiting list for receiving a MATRIX-A therapy
Arm Title
control group
Arm Type
No Intervention
Arm Description
Adolescents with no history of substance use disorders no other intake of psychotropic substances such as psychotropic medication
Intervention Type
Other
Intervention Name(s)
adapted treatment according to the MATRIX-A therapy
Intervention Description
cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters
Primary Outcome Measure Information:
Title
Aim 1: Sociodemographic background
Description
Sociodemographic background of adolescents with substance use disorders via self-constructed items: age (in years) gender (male/female) highest education (primary school/ currently in high school/ dropped out of school/ finished compulsory school/ finished apprenticeship/ currently doing apprenticeship) migration background (no/ yes > asks for specification) nationality (German/ other > asks for specification) relationship status (single/ married/ separated/ divorced/ widowed/ civil union/ domestic partnership/ other > asks for specification)
Time Frame
T0
Title
Aim 2: Psychiatric comorbidities - MINI-KID
Description
Current psychiatric comorbidities according to Diagnostic and Statistic Manual of Mental Disorders, 5th Ed. (DSM-5) assessed via Mini International Neuropsychiatric Interview for Children and Adolescents (MINI KID), a structured diagnostic interview. Single interview questions rated (yes / no). DSM-5 diagnoses for past month (or other if specified) in accordance with MINI-KID scoring algorithms.
Time Frame
T0, T1, T2
Title
Aim 2: Change in substance use
Description
Changes in self-reported substance use between T0, T1, T2. Assessed via quantity and frequency questions for different substance categories.
Time Frame
T0, T1, T2
Title
Aim 3: Changes in biomarkers related to substance use disorders
Description
cumulative stress: hair cortisol levels in a single hair sample. Measured in ng/ml. epigenetic changes: methylation pattern in a single blood sample. Measured in %. immunological changes: immune marker Interleukin-6 in a single blood sample. Measured in ng/ml.
Time Frame
T0, T1, T2
Title
Aim 4: Subjective therapy outcomes
Description
Evaluation of possible therapy effects (e.g. knowledge, relapse prevention skills, emotions/affects, maintenance self-efficacy, motivation, stress tolerance) with 5-point Likert options (not at T0). Substance use disorder severity assessed via Drug Use Disorders Identification Test (DUDIT). Measured in a test persons's scoring number on the DUDIT scale. Change from baseline DUDIT score to T1 and T2 DUDIT scores.
Time Frame
T0, T1, T2
Title
Aim 4: Objective therapy outcomes
Description
- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.
Time Frame
between T0 and T1
Title
Aim 5: Change in baseline parenting skills
Description
Assessment of parenting skills (communication skills) via descriptive self-reports. Change from T0 to T1. Measured in self-reported description of change.
Time Frame
T0, T1
Title
Aim 5: Change in baseline parental stress reports - ESF
Description
Change from self-reported baseline parent stress level to T1 anjd T2 parental stress levels. 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.
Time Frame
T0, T1, T2
Secondary Outcome Measure Information:
Title
Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)
Description
Emotional, behavioral and social problems associated with adolescents with substance use disorders: 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.
Time Frame
Baseline data collection
Title
Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)
Description
Emotional, behavioral and social problems associated with adolescents with substance use disorders: 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.
Time Frame
T0, T1, T2
Title
Adolescent depressivity - BDI-II
Description
Psychiatric comorbidities associated with adolescents with substance use disorders: Data collection with help of the Beck Depression Inventory (BDI-II). Measured in a test persons's scoring number on the scale.
Time Frame
T0, T1, T2
Title
Mental distress - Brief Symptom Checklist
Description
Psychiatric comorbidities associated with adolescents with substance use disorders: 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.
Time Frame
T0, T1, T2
Title
Adolescent satisfaction with life
Description
Psychiatric comorbidities associated with adolescents with substance use disorders: 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).
Time Frame
T0, T1, T2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Adolescents: Inclusion Criteria: Age 12.00-17.99 Therapy / wait list group: current substance use disorder Controls: no history of substance use disorders 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 Controls: Drug intake modulating the central nervous system Main psychiatric disorders Current substance use Parents: 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 substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sören Kuitunen-Paul, Dipl.-Psych.
Phone
+49 (0)351 458-7601
Email
soeren.kuitunen-paul@ukdd.de
First Name & Middle Initial & Last Name or Official Title & Degree
Yulia Golub, Dr.Dr.habil.
Phone
+49 (0)351 458-7601
Email
yulia.golub@ukdd.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veit Roessner, Prof. Dr.
Organizational Affiliation
Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden
Official's Role
Study Director
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital C.G.Carus
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sören Kuitunen-Paul, Dipl.-Psych.
Phone
+49 (0)351 458-7601
Email
soeren.kuitunen-paul@ukdd.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15204668
Citation
Zweben JE, Cohen JB, Christian D, Galloway GP, Salinardi M, Parent D, Iguchi M; Methamphetamine Treatment Project. Psychiatric symptoms in methamphetamine users. Am J Addict. 2004 Mar-Apr;13(2):181-90. doi: 10.1080/10550490490436055.
Results Reference
background
PubMed Identifier
27693866
Citation
Warden D, Sanchez K, Greer T, Carmody T, Walker R, Dela Cruz A, Toups M, Rethorst C, Trivedi MH. Demographic and clinical characteristics of current comorbid psychiatric disorders in a randomized clinical trial for adults with stimulant use disorders. Psychiatry Res. 2016 Dec 30;246:136-141. doi: 10.1016/j.psychres.2016.09.007. Epub 2016 Sep 15.
Results Reference
background
PubMed Identifier
15139869
Citation
Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. doi: 10.1111/j.1360-0443.2004.00707.x.
Results Reference
background

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Addiction in Adolescence - Pathomechanisms and Treatment Evaluation

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