Evaluation of the DELTA treatment program for adolescents with substance use disorder, adapted for youth welfare homes
Organizational Data
- DRKS-ID:
- DRKS00027913
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-02-01
- Last update in DRKS:
- 2024-03-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
DELTA-JU
URL of the study
No Entry
Brief summary in lay language
The existing DELTA-program (16 group sessions, 8 1-on-1 sessions) for teenagers with problematic drug use will be adapted (DELTA-JU) for application in youth welfare institution. In order to achieve this aim, we will adapt the existing DELTA manual over 24 months and apply the resulting DELTA-JU manual in youth welfare institutions. In the first four months we will conduct interviews with n = 10 persons working in the institutions to investigate their concerns and wishes for the resulting treatment manual. In the following 20 months, we will conduct the DELTA-JU group program with n = 50 teenagers with problematic drug use. We will randomly decide which group will start immediately and which group will start after a waitlist period (16 weeks). At the same time, we will conduct 1-day workshops for personnel at the participating institutions. In the last two month we will conduct the final statistical analysis, expecting reduced tobacco smoking and reduced problems with drug use in participating teenagers.
Brief summary in scientific language
Background: The DELTA intervention contains 16 weekly group sessions plus additional individual sessions and educational session for parents. It aims to reduce substance use and related problems such as substance use disorders (SUD) in adolescents. Recent results indicated positive effects in psychiatric outpatients. Conducting DELTA in youth welfare settings seems feasible, however, organizational and content adjustments are warranted. Furthermore, elements of smoking cessation should be added to DELTA in order to reduce relapse risks and to prevent negative health consequences. This protocol describes the DELTA-JU study in which we will further develop and evaluate the DELTA. Methods/design: The DELTA-JU study is separated into three stages: In the adjustment stage during months 1-4, we will revise the DELTA manual based on expert feedback from n=10 semi-structured interviews with personnel from youth welfare institutions specialized in serving adolescents with SUD in the study region, analyzed with content analysis. In the sampling stage during months 5-22, participants will be recruited from cooperating institutions. Participants qualifying for a SUD and willing to regularly participate in the 16 weekly DELTA-JU group sessions will be enrolled to either one of two arms (cluster randomization: immediate intervention, waitlist with subsequent intervention 16 weeks later). Adolescents will be assessed twice at baseline (BL, a week before the intervention starts) and follow-up (FU, 16 weeks after first group session) with an additional pre-assessment (PRE, 16 weeks before intervention starts) for the waitlist group. Assessment procedures include questionnaires and clinical interviews amongst others. At the same time, institutional personnel will receive a one-day workshop on SUD-relevant topics based on the DELTA parental education group and on feedback from the qualitative interviews. Personnel will also be assessed twice (BL, FU) with questionnaires. In the dissemination stage during months 23-24, final study evaluation results will be prepared and submitted for publication. Discussion: This study will create a setting-specific manual (DELTA-JU) for vulnerable adolescents suffering from SUDs, and, in many cases, from co-occurring mental disorders. If shown to be effective, DELTA-JU can be disseminated within other institutions of youth welfare.
Health condition or problem studied
- ICD10:
- F10.2
- ICD10:
- F11.2
- ICD10:
- F12.2
- ICD10:
- F13.2
- ICD10:
- F14.2
- ICD10:
- F15.2
- ICD10:
- F16.2
- ICD10:
- F17.2
- ICD10:
- F18.2
- ICD10:
- F19.2
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Immediate condition: receives DELTA-JU treatment after initial assessment
- Arm 2:
- Waitlist condition: receives DELTA-JU treatment 16 weeks after initial assessment
Endpoints
- Primary outcome:
- Outcome name: SUD severity Method of measurement: scores from AUDIT, DUDIT, FTND Timepoints: baseline, 16-week follow-up Outcome name: Craving Method of measurement: MaCS score Timepoints: baseline, 16-week follow-up Outcome name: Substance use Method of measurement: past-month quantity & frequency reported in generic interview Timepoints: baseline, 16-week follow-up Outcome name: SUD-related knowledge Method of measurement: scoring of items in generic questionnaires (GEJ, GEB) Timepoints: baseline, 16-week follow-up
- Secondary outcome:
- Outcome name(s): Severity of psychopathology. Method of measurement: BDI-II, PQ-16, UCLA-PTSD, YSR questionnaires. Timpoints: baseline, 16-week follow-up. Outcome name: life satisfaction. Method of measurement: SWLS questionnaire. Timpoints: baseline, 16-week follow-up. Outcome name: perceived stress. Method of measurement: ERI-S-10, PSS-10 questionnaires. Timpoints: baseline, 16-week follow-up.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Vollstationäre Jugendwohngruppen / youth wellfare institutions Region Sachsen/Saxony
Recruitment period and number of participants
- Planned study start date:
- 2022-02-01
- Actual study start date:
- 2022-02-07
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 12 Years
- Maximum Age:
- 17 Years
- Additional Inclusion Criteria:
- SUD diagnosis or chronic substance use during the past
Exclusion Criteria
- intelligence quotient is below 70 - did not attend any of the 16 sessions for whatever reason (applies only to Baseline-FollowUp analyses) - study participation was discontinued due to an adverse event (applies only to Baseline-FollowUp analyses)
Addresses
Primary Sponsor
- Address:
- Technische Universität Dresden, Faculty of Medicine, Dept. of Child and Adolescent PsychiatryFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-458-7168
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinikum-dresden.de/de/das-klinikum/kliniken-polikliniken-institute/kjp/forschung
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Carl von Ossietzky Universität Oldenburg, Fakultät VI Medizin und Gesundheitswissenschaften, Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und PsychotherapieProf. Dr. Dr. habil. Yulia GolubRahel-Straus Str. 1026133 OldenburgGermany
- Telephone:
- +49-441-403-10061
- Fax:
- +49-441-403-10063
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/humanmedizin/abteilungen/universitaetsklinik-kjpp
Contact for Public Queries
- Address:
- Technische Universität Dresden, Faculty of Medicine, Dept. of Child and Adolescent PsychiatryFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49 (0)351 458-7168
- Fax:
- +49 (0)351 458-5754
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinikum-dresden.de/de/das-klinikum/kliniken-polikliniken-institute/kjp/forschung
Principal Investigator
- Address:
- Carl von Ossietzky Universität Oldenburg, Fakultät VI Medizin und Gesundheitswissenschaften, Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und PsychotherapieProf. Dr. Dr. habil. Yulia GolubRahel-Straus Str. 1026133 OldenburgGermany
- Telephone:
- +49-441-403-10061
- Fax:
- +49-441-403-10063
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://uol.de/humanmedizin/abteilungen/universitaetsklinik-kjpp
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Roland-Ernst-Stiftung für GesundheitswesenNaumannstr. 801309 DresdenGermany
- Telephone:
- +49-351-656-159-17
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://roland-ernst-stiftung.com/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der TU DresdenFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-4582992
- Fax:
- +49-351-4584369
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-12-20
- Ethics committee number:
- EK66022018 inc. Amendments
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-01-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Not applicable since no consent for data transfer is acquired from participants.
Study protocol and other study documents
- Study protocols:
- Kuitunen-Paul S, Basedow LA, Roessner V, Golub Y. Study protocol: the pragmatic, exploratory DELTA-JU trial of the group-based multimodal DELTA intervention for abstinent adolescents with substance use disorders living in youth welfare institutions. Front Psychiatry. 2023 May 26;14:1025347. doi: 10.3389/fpsyt.2023.1025347. PMID: 37383612; PMCID: PMC10298162.
- Study abstract:
- Pubmed Abstract https://pubmed.ncbi.nlm.nih.gov/37383612/
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry