Addiction in Adolescence - Pathomechanisms and Treatment Evaluation

NCT03444974 | Unknown

• 1 other identifier: MATRIX-A
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Adolescent Behavior

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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)

  T0

• 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.

  T0, T1, T2

• 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.

  T0, T1, T2

• 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.

  T0, T1, T2

• 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.

  T0, T1, T2

• Aim 4: Objective therapy outcomes

  \- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.

  between T0 and T1

• 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.

  T0, T1

• 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.

  T0, T1, T2

Secondary Outcomes (5)

• Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)

  Baseline data collection

• Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)

  T0, T1, T2

• Adolescent depressivity - BDI-II

  T0, T1, T2

• Mental distress - Brief Symptom Checklist

  T0, T1, T2

• Adolescent satisfaction with life

  T0, T1, T2

Study Arms (5)

Patient therapy group

ACTIVE COMPARATOR

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

Other: adapted treatment according to the MATRIX-A therapy

Parental therapy group

ACTIVE COMPARATOR

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

Other: adapted treatment according to the MATRIX-A therapy

Patient waiting list group

NO INTERVENTION

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

Parental waiting list group

NO INTERVENTION

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

control group

NO INTERVENTION

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

Interventions

adapted treatment according to the MATRIX-A therapy OTHER

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

Parental therapy group; Patient therapy group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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:
• 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
• Current substance abuse

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 15204668 BACKGROUND

• 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.

  PMID: 27693866 BACKGROUND

• 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.

  PMID: 15139869 BACKGROUND

• Basedow LA, Kuitunen-Paul S, Wiedmann MF, Roessner V, Golub Y. Evaluation of the multimodal DELTA therapy for adolescents with substance use disorders: an exploratory pilot trial. Front Psychiatry. 2024 Jan 3;14:1284342. doi: 10.3389/fpsyt.2023.1284342. eCollection 2023.

  PMID: 38234368 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Adolescent Behavior; Marijuana Abuse

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Veit Roessner, Prof. Dr.

  Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden

  STUDY DIRECTOR

Central Study Contacts

Sören Kuitunen-Paul, Dipl.-Psych.

CONTACT

+49 (0)351 458-7601; soeren.kuitunen-paul@ukdd.de

Yulia Golub, Dr.Dr.habil.

CONTACT

+49 (0)351 458-7601; yulia.golub@ukdd.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 26, 2018
• Study Start: August 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

DE (1)