Individualised short-term therapy for adolescents impaired by attention-deficit/hyperactivity disorder despite previous routine care treatment (ESCAadol)—Study protocol of a randomised controlled trial within the consortium ESCAlife

Childhood attention-deficit/hyperactivity disorder (ADHD) shows a high tendency to persist into adulthood [1‐3], causes significant social, emotional and academic impairment for the individual and poses a risk of failing to achieve important educational and psychosocial developmental goals [4]. Highly comorbid with subsequent adolescent and adult depression, anxiety and substance abuse, it is also a predisposing factor for delinquency [5, 6]. ADHD confers a substantial economic burden with high direct and indirect costs for society [7, 8]. There is a great need for effective, feasible and safe treatment strategies. However, the evaluation of treatment response in efficacy studies is typically based on highly selected patient groups, excluding patients with poor compliance, most comorbid conditions or common psychosocial adversity [9].

Psychopharmacological treatment options, especially psychostimulants and atomoxetine, have been studied extensively and their efficacy in targeting core symptoms of ADHD in children and adolescents has been validated by a large body of research [10‐12]. In combination with psychoeducation, pharmacotherapy is recommended as treatment of choice for severe and impairing ADHD symptoms according to national and international guidelines [13]. However, the benefits of pharmacotherapy for adolescents might be reduced in patients with comorbid disorders [12, 14]. Since medication adherence especially in adolescence is poor [15, 16], non-pharmacological treatment options are indispensable.

While there is empirical support for the efficacy of psychosocial interventions in children [17] and adults [18], cognitive behavioural therapy (CBT) approaches in adolescent ADHD are comparatively scarce. A study assessing CBT in a group setting found a reduction in ADHD symptoms and functional impairment in the treatment group [19], whereas the usefulness of rational emotive therapy [20] in adolescents with ADHD could not be confirmed.

Especially controlled studies on individual psychotherapy in adolescents are largely lacking [21, 22]. To date, the available empirical evidence is limited to a small number of mostly uncontrolled studies and existing randomised controlled trials (RCTs) comprised exclusively og multicomponent interventions [12]. An unpublished Canadian trial [Mongia M, Hechtman L: Cognitive behaviour therapy in adolescents with attention deficit hyperactivity disorder: a pilot study, unpublished] reported a 14-session CBT intervention and additional coaching calls as an add-on to psychopharmacological treatment to result in a reduction of ADHD symptoms as well as improvements in self-esteem and level of disability. However, the small sample size (N = 18) and the lack of a control group are serious caveats of this study. Another study found an adaptation of CBT for adult ADHD to adolescents with residual symptoms under medication to bring about positive changes on a range of variables such as inattention, medication adherence, self-esteem, family and academic functioning (uncontrolled study [23]). There is some evidence for the efficacy of a mindfulness training for adolescents and their parents (uncontrolled study; [24]). The authors reported positive effects on attention and behavioural problems, executive functioning and parenting while stressing the need for maintenance strategies to sustain those effects.

Furthermore, there are demonstrated benefits of an organisational skills training and reinforcement of goal achievement for older children [25] and for adolescents in terms of ADHD symptoms and impairment in the framework of extensive summer treatment programmes or school-based interventions [21, 26], and a reduction of parent-teen conflicts through family-based interventions for adolescents and their parents [27]. The Supporting Teens’ Academic Needs Daily (STAND) programme demonstrated the superiority of a combination of family sessions and group sessions for parents to treatment as usual, targeting family cooperation by teaching both adolescents and parents with a focus on improving academic performance. The authors found improvements in academic functioning and ADHD symptoms [28]. Most recently, Boyer and colleagues [29‐31] showed comparable positive effects of two non-ADHD-specific CBT interventions, Plan My Life versus Solution-Focused Treatment, in a randomised trial. Each intervention arm combined parent and adolescent sessions with motivational enhancement therapy.

The scarcity of (psycho-)therapy research for adolescent ADHD may partly be due to the low compliance seen in youths with ADHD [32]. Furthermore, the development and evaluation of general treatment strategies is complicated by the need for individualised treatment options taking into account the broad comorbid development, the shift in ADHD core symptoms, and psychosocial adversity as well as family dysfunction, e.g. poor parenting skills and parental mental health problems [7, 33, 34]. Previous trials conducted by our study group on treatment options for childhood and adult ADHD [35‐38] and the development of interventions for adolescents with achievement problems including ADHD symptoms [39] underscored the feasibility of successfully conducting clinical trials with adolescent patients.

In sum, especially individualised treatment plans for adolescent ADHD need to be developed and evaluated combining psychosocial and pharmacological interventions in the framework of a multimodal treatment strategy. Treatment must take into account the prevalent compliance problems of youths with ADHD and must be individualised with respect to each patient’s constellation of impairment in terms of ADHD symptom expression and developmental comorbidity.

To address the needs of this group of patients, the ESCAadol study (Evidence-based stepped care of ADHD: individualised short-term therapy for adolescents impaired by ADHD despite previous routine care treatment) was devised. As adolescent patients with ADHD often present with comorbid diagnoses and severe impairment, the target group of ESCAadol are adolescents aged 12–17 years who are still severely impaired by their ADHD symptoms according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [40] despite having been in routine clinical care for at least 6 months.

Based on established interventions, we composed a short-term, Individualised Modular Treatment Programme (IMTP), adapting elements of dialectical behaviour therapy (DBT) for adolescents in general [41] and specifically for ADHD in adults [42] as well as interventions from the German treatment manuals for externalising disorders (THOP, [43]), performance problems in adolescents (SELBST, [44]), family interventions (PLAN-E, [45]) and social skills training (FESKO, [46]). We chose interventions targeting ADHD symptoms and related issues, such as emotion regulation and self-confidence, in addition to organisational difficulties, since these are emerging as critical issues in adolescence. For an outline of the focus areas included in the programme and their respective therapeutic targets, please refer to Table 3.

The IMTP consists of 10 sessions and addresses deficits in cognitive control, emotion regulation, organisation and planning, conflict management, medication compliance and parental mental health. The choice of a short-term treatment accounts for the poor therapy adherence and motivation often seen in adolescent ADHD, is supposed to be cost-effective, supports trial feasibility and facilitates broad dissemination. Different treatment modules will allow for the adaptation to specific impairment patterns. This programme will be evaluated in a multi-centre, randomised effectiveness study with an active control condition and blinded observer ratings of the primary endpoint (change in ADHD symptoms). Participants in the active control condition will be treated with a telephone-assisted self-help (TASH) programme for parents of adolescents with ADHD. Although child- or adolescent-centred interventions become more important the older the patient is, parenting interventions are still recommended for the treatment of ADHD in adolescents [47]. Self-help interventions have already been shown to have effects on parent-rated externalising behaviour problems in preschool- and school-aged children [48, 49]. Moreover, a pilot-study using a pre-post design found a large improvement in parent-rated ADHD symptoms during the TASH intervention used in this study [50]. We chose TASH as the active control condition since it was designed as a first step in routine care for unselected patient groups and we thus assume low to zero effectiveness in our highly affected and persistent clinical sample that has already received counselling and treatment. The therapeutic strategies applied offer sufficient additional support for the family while the patient remains in routine clinical care during study participation. Weekly assessments ensure patients’ safety.

Should this newly developed, highly individualised, short-term, non-pharmacological intervention prove to be effective in ameliorating adolescent ADHD symptoms, it will offer a cost-efficient economic and feasible treatment option which is designed to create high treatment motivation for a patient group with frequent compliance issues and may easily and broadly be implemented in clinical care.

Our study aims to add to the development of treatment strategies for adolescents and to the evidence base of treatment approaches. The study will furthermore investigate predictors and moderators of treatment response. This report presents Version 6 (20 December 2016) of the study protocol. We followed the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) Statement 2013 (see Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents). For the complete World Health Organization Trial Registration Data Set, please see Additional file 2.

Our primary hypothesis is a significantly greater reduction in the primary outcome (ADHD symptoms) in the IMTP group compared to the active control condition TASH. On secondary outcomes such as global impairment, internalising and externalising symptoms, we expect greater benefit in the IMTP group compared to TASH, whereas parenting is expected to improve more in the parent-focused TASH group. We expect treatment effects and group differences to remain stable at follow-up.

Adolescence is a crucial period for determining patients’ life trajectories in terms of mastering educational and psychosocial developmental tasks. However, in adolescents with ADHD motivation to seek treatment, treatment adherence and compliance are often lacking [15]. Furthermore, comorbidities gain importance; however, this is often not adequately addressed by standard psychological and pharmacological interventions for ADHD. Psychopharmacological treatment is of limited effect in this age group [12, 14]. Thus, there is a strong need for effective psychosocial interventions that generate high motivation and compliance and that also take into account non-core ADHD symptoms, such as emotion regulation and self-image, as well as comorbidity. Considering the limited empirical evidence for non-pharmacological treatment options of ADHD in adolescence, ESCAadol is conceptualised as a RCT for the evaluation of an innovative short-term CBT programme tailored to the needs of ADHD patients aged 12 to 17 years. One limitation of the trial is the absence of a waiting control group under routine clinical care. However, considering the limited number of potential participants in that age group, limiting the study design to two groups seemed necessary for obtaining a sufficient sample size. Therefore, we decided on an active control treatment to provide at least minimal support for adolescents in that crucial period for ethical reasons. Furthermore, demonstrating superiority of a short-term behavioural therapy programme over an active control condition presents a more rigorous test of the treatment efficacy than comparing it to no intervention. This RCT will be conducted in accordance with the highest standards of psychotherapy research, employing blinded outcome ratings and relying on power analyses to ensure adequate statistical power to detect effects. All raters and therapists receive special training prior to being involved with the study. The main treatment comprises a manualised therapy. Adherence to the manual will be checked. We compare the efficacy of this adolescent-centred intervention with a parent-centred telephone-assisted self-help programme as an active control treatment. Taking into account the broad spectrum of clinical presentations, comorbidities and environmental factors, the study furthermore aims at achieving a sample size that allows for the identification of predictors of treatment response across different modalities (psychometric variables, neuropsychological tests, brain functioning during rest and cognitive activity, structural brain imaging and biomarkers in blood and saliva). Results aim to fill a knowledge gap in the treatment of adolescents with ADHD who do not benefit from routine clinical care and at evaluating a cost-effective and feasible individualised treatment that can easily be implemented in routine clinical practice within the context of a personalised medicine approach.