Substance Use DisordersMATRIX-ANCT03444974
Addiction in Adolescence - Pathomechanisms and Treatment Evaluation
A study testing adapted treatment according to the MATRIX-A therapy in people with Substance Use Disorders and Adolescent Behavior, run by Technische Universität Dresden at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Adolescent Behavior
- What is being tested?
- adapted treatment according to the MATRIX-A therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 12.00-17.99
- Therapy / wait list group: current substance use disorder
- Controls: no history of substance use disorders
- 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
Who cannot join
- 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:
Show all 11Show fewer
- Drug intake modulating the central nervous system
- Main psychiatric disorders
- Current substance use
- Parents:
- Current substance abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital C.G.Carus
Dresden, Saxony, 01307
Sören Kuitunen-Paul, Dipl.-Psych., +49 (0)351 458-7601, soeren.kuitunen-paul@ukdd.de
About this study
Official title: Addiction and Substance Dependence in Adolescence - Neurobiological Pathomechanisms and Treatment Evaluation
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.
Read the 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.
- Conditions
- Substance Use Disorders, Adolescent Behavior
- Being tested
- adapted treatment according to the MATRIX-A therapy
- Keywords
- drugs, youth, adolescence, abuse, dependence, Tetrahydrocannabinol (THC), Methamphetamine (Crystal Meth), Marihuana, comorbidity, treatment, etiopathology, sociodemographics, Saxony, MATRIX, Psychotherapy
- Medical subject headings
- Substance-Related Disorders, Adolescent Behavior, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted treatment according to the MATRIX-A therapyOther
cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters
| Study group | Role | What they receive |
|---|---|---|
| Patient therapy group | Active comparator | * Adolescents with substance use disorders
* Receiving an adapted treatment according to the MATRIX-A therapy Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T0, T1, T2
Aim 4: Objective therapy outcomes
- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.
Measured: 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.
Measured: 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.
Measured: T0, T1, T2
Secondary outcomes (5)
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.
Measured: Baseline data collection
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.
Measured: T0, T1, T2
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.
Measured: T0, T1, T2
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.
Measured: T0, T1, T2
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).
Measured: T0, T1, T2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Aug 2018
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veit Roessner, Prof. Dr., Study director, Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444974
- Sponsor's protocol ID
- MATRIX-A
- Acronym
- MATRIX-A
- Status last verified
- Mar 2019
- First submitted
- 6 Feb 2018
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15204668Warden 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.
PubMed 27693866Rawson 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.
PubMed 15139869Basedow 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.
PubMed 38234368
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction and Substance Dependence in Adolescence - Neurobiological Pathomechanisms and Treatment Evaluation
- ClinicalTrials.gov ID
- NCT03444974
- Acronym / sponsor ID
- MATRIX-A / MATRIX-A
- Conditions
- Substance Use Disorders, Adolescent Behavior
- Keywords
- drugs, youth, adolescence, abuse, dependence, Tetrahydrocannabinol (THC), Methamphetamine (Crystal Meth), Marihuana
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient therapy group | Active comparator | Other: adapted treatment according to the MATRIX-A therapy* Adolescents with substance use disorders * Receiving an adapted treatment according to the MATRIX-A therapy |
| Parental therapy group | Active comparator | Other: 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 |
| 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 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 12.00-17.99
- Therapy / wait list group: current substance use disorder
- Controls: no history of substance use disorders
- At least one child/protégé with problematic substance abuse
- No current substance abuse on their own
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted treatment according to the MATRIX-A therapycognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters | Other | Parental therapy group, Patient therapy group |
Primary outcome
Aim 1: Sociodemographic background
Time frame: T0
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
Time frame: T0, T1, T2
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
Time frame: T0, T1, T2
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
Time frame: T0, 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 outcomes
Time frame: T0, 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 outcomes
Time frame: between 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 skills
Time frame: T0, T1
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
Time frame: T0, T1, T2
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.
5 secondary outcomes
Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)
Time frame: Baseline data collection
Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)
Time frame: T0, T1, T2
Adolescent depressivity - BDI-II
Time frame: T0, T1, T2
Mental distress - Brief Symptom Checklist
Time frame: T0, T1, T2
Adolescent satisfaction with life
Time frame: T0, T1, T2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Background: PubMed 15204668Zweben 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.
- Background: PubMed 27693866Warden 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.
- Background: PubMed 15139869Rawson 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.
- Derived from this study: PubMed 38234368Basedow 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.
- Department's main web site (German)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veit Roessner, Prof. Dr. study director
Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted treatment according to the MATRIX-A therapy in people with Substance Use Disorders and Adolescent Behavior, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sören Kuitunen-Paul, Dipl.-Psych. (+49 (0)351 458-7601, soeren.kuitunen-paul@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Sociodemographic background (time frame: T0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444974, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.