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 Psychiatry
Fetscherstr. 74
01307 Dresden
Germany
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 Psychotherapie
Prof. Dr. Dr. habil. Yulia Golub
Rahel-Straus Str. 10
26133 Oldenburg
Germany
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 Psychiatry
Fetscherstr. 74
01307 Dresden
Germany
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 Psychotherapie
Prof. Dr. Dr. habil. Yulia Golub
Rahel-Straus Str. 10
26133 Oldenburg
Germany
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 Gesundheitswesen
Naumannstr. 8
01309 Dresden
Germany
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 Dresden
Fetscherstr. 74
01307 Dresden
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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

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