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Addiction in Adolescence - Pathomechanisms and Treatment Evaluation

Addiction and Substance Dependence in Adolescence - Neurobiological Pathomechanisms and Treatment Evaluation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444974
Acronym
MATRIX-A
Enrollment
450
Registered
2018-02-26
Start date
2018-08-01
Completion date
2021-12-31
Last updated
2019-04-01

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

Conditions

Adolescent Behavior, Substance Use Disorders

Keywords

drugs, youth, adolescence, abuse, dependence, Tetrahydrocannabinol (THC), Methamphetamine (Crystal Meth), Marihuana, comorbidity, treatment, etiopathology, sociodemographics, Saxony, MATRIX, Psychotherapy

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.

Interventions

OTHERadapted treatment according to the MATRIX-A therapy

cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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 parental stress levels and parenting skills in the treatment group parents in comparison to waiting-list parents.

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Aim 5: Change in baseline parental stress reports - ESFT0, T1, T2Change 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.
Aim 2: Change in substance useT0, T1, T2Changes 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 disordersT0, T1, T2* 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 outcomesT0, T1, T2* 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 outcomesbetween T0 and T1\- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.
Aim 5: Change in baseline parenting skillsT0, T1Assessment of parenting skills (communication skills) via descriptive self-reports. Change from T0 to T1. Measured in self-reported description of change.
Aim 1: Sociodemographic backgroundT0Sociodemographic 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-KIDT0, T1, T2Current 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.

Secondary

MeasureTime frameDescription
Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)T0, T1, T2Emotional, 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-IIT0, T1, T2Psychiatric 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 ChecklistT0, T1, T2Psychiatric 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 lifeT0, T1, T2Psychiatric 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).
Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)Baseline data collectionEmotional, 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.

Countries

Germany

Contacts

Primary ContactSören Kuitunen-Paul, Dipl.-Psych.
soeren.kuitunen-paul@ukdd.de+49 (0)351 458-7601
Backup ContactYulia Golub, Dr.Dr.habil.
yulia.golub@ukdd.de+49 (0)351 458-7601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026