Individualized short-term therapy for adolescents impaired by ADHD despite previous routine care treatment (ESCAdol) - a randomized controlled trial within the consortium ‘ESCAlife’

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00008974
• Date of registration: 28/12/2015
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinikum Würzburg
• Public title: Individualized short-term therapy for adolescents impaired by ADHD despite previous routine care treatment (ESCAdol) - a randomized controlled trial within the consortium ‘ESCAlife’
• Scientific title: Individualized short-term therapy for adolescents impaired by ADHD despite previous routine care treatment (ESCAdol) - a randomized controlled trial within the consortium ‘ESCAlife’ - ESCAadol
• Date of first enrolment: 14/01/2016
• Target sample size: 160
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00008974
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Marcel Romanos
• Affiliation: Universiitätsklinikum WürzburgKlinik für Kinder- und Jugendpsychatrie, Psychosomatik u. Psychotherapie

• Name: Marcel Romanos
• Affiliation: Universiitätsklinikum WürzburgKlinik für Kinder- und Jugendpsychatrie, Psychosomatik u. Psychotherapie

Key inclusion & exclusion criteria

Inclusion criteria: - ADHD according to DSM-5 criteria; diagnosis established by clinician-rated ADHD-Checklist (DCL-ADHS)
- patient has been in ADHD routine care for a minimum of 6 months
-no sufficient benefit from previous interventions developed for the treatment of ADHD children or ADHD adults (insufficient benefit defined as significant impairment by ADHD and/or co-morbid symptoms: CGI-S > 4)
- patients and primary caregiver speak sufficient German

Exclusion criteria: - IQ < 80
- comorbidity: pervasive developmental disorder, schizophrenia, bipolar disorder, severe depressive episode
- need for inpatient treatment
- after TAU-Phase co-treatment including: a) intensive psychotherapies on a biweekly or more intense basis or b) medication which is not constant or not licensed for the treatment of ADHD and co-morbid conditions


Age minimum: 12 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Attention deficit-/hyperactivity disorder (ADHD)
F90

Hyperkinetic disorders

Intervention(s)

Group 1: Individualised Modular Treatment Program (IMTP)

The individualised modular treatment program as a focused short-term cognitive behavioural intervention consists of 10 weekly sessions à 60 minutes over a period of 3 months. The content of the opening and the closing sessions (1, 2, 9, 10) are mandatory for all participants. Sessions 3-8 comprise the strongly individualized part of the treatment, where different modules can be chosen depending on the adolescents’ core problem areas for a focused and economical treatment of persistent difficulties.

Sessions 1 and 2 focus on the establishment of the therapeutic relationship, psychoeducation, the development of an individual concept of the disorder and the selection of 3 focus modules for the individualized part of the therapy. Each module spans two treatment sessions. Session 9 and 10 aim at recapitulating and consolidating the content of the previous sessions and planning the future treatment.

The following modules can be selected:
A) Organization’s key – Improvement of structuring and planning in the daily routine
B) Full concentration – Battle against chaos, distractibility and procrastination
C) The Courage-Module – Cheering for yourself with positive thinking
D) The Emotion-Module – Dealing well with (negative) feelings
E) Less stress – greater satisfaction: problem solving strategies and strategies against stress
F) The Medication-Module: finding the right handle on ADHD medication
G) The search for a kick – The risk of addiction
H) Improving communication in the family – Toward a better relationship (For parents and adolescents)
I) Educational training (For parents)
J) Keeping an eye on your own well-being (For parents)

Group 2: Telephone-assisted Self Help (TASH)

Parents receive 8 booklets over a

Primary Outcome(s)

Change in blinded clinician-rated ADHD-Checklist (DCL-ADHS) scores between T2 (pre-intervention) and T3 (post-Intervention after 3 month)

Secondary Outcome(s)

Change from T2 (pre-intervention) to T3 (post-intervention) in impairment scores on the Clinical Global Impression Scale (CGI; clinician-rated), ADHD symptoms (SBB-ADHS, FBB-ADHS; patient-, parent- and teacher-rated), symptoms of oppositional-defiant and conduct disorder (SBB-SSV, FBB-SSV, clinical interview DCL-SSV; patient-, parent- and teacher- and clinician-rated), ADHD-related functional impairment (WFIRS-P; parent-rated), internalizing and externalizing symptoms (CBCL; parent-rated),- quality-of-life (KIDSCREEN-10; patient- and parent-rated) and parenting (FZEV, FPNE, VER; parent-rated).

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung Dienstsitz Berlin

Ethics review

Status: Approved
Approval date: 15/10/2015
Contact:

[e-mail]

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie

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Results

• Date Completed: 02/02/2021
• URL: http://drks.de/search/en/trial/DRKS00008974#studyResults