According to the German 13th Child and Youth Report and a statement from the German government, effective trauma-sensitive interventions are required in this population [ 55 ].
Their needs are under-addressed in both the youth welfare system and the health care system. Therefore, an early intervention approach using evidence-based CBT interventions to reduce AD symptoms is urgently needed, and has not yet been investigated. Given the variability and complexity of the clinical picture of AD in combination with comorbid conditions, a modular approach with a stepped care design is necessary, which tailors evidence-based interventions to fit patient needs.
Most previous studies used a group-based standardized treatment approach, both in parent-based interventions and in child-based cognitive-behavioral interventions. Only a small number of studies have combined the effective components of child-based, parent-based, and teacher-based interventions. Assessments of individual modular approaches are rare. The effects on specific measures of AD and moderating as well as mediating factors are largely unknown.
Almost none of the studies published to date, or which are currently being processed, assessed the effects of an intervention within a stepped care approach except Symptoms of AD seem to vary broadly and differ in intensity. Thus, a stepped care approach that includes interventions with increasing intensity could meet the individual needs of patients and families that arise from different forms of AD. In general, self-help or online PMT have proven to be effective in reducing child behavior problems. However, they might only be capable of reaching a subpopulation of parents [ 56 ], e.
Self-help interventions can thus serve as a time- and cost-effective first step of intervention that can reduce symptoms in a subpopulation [ 25 , 49 ].www.regenerativewebinar.com/wp-content/map11.php
Treatment of Children With Peer Related Aggressive Behavior - ICH GCP - Clinical Trials Registry
These children are expected to have higher rates of AD than children who live with their natural parents. It is assumed that the treatment effects on AD in children in OHC may differ from the effects on children living with their parents, due to a higher symptom load and more adverse childhood experiences in the former group.
Furthermore, professional educational staff are already involved in institutional care. Online guidance for effective parenting cannot be considered as an appropriate intervention, since the staff of the youth welfare service will already possess knowledge about positive parenting. Therefore, there was a sound rationale for a specific study design for this population, which provides direct, intensive treatment. Treatment strategies for multiple problems are organized into self-contained modules that can be used multiple times or not at all, and can be combined as needed; clinical decision-making flowcharts give guidance about which modules to use and when to use them for a particular patient [ 49 ].
Moreover, this intensive personalized intervention will be applied within a stepped care approach only in those cases in which a less intensive and less expensive self-help online intervention has proven to be insufficiently effective see ADOPT Online. What is the clinical significance of the symptom change in terms of normalization rates in comparison to a control group of participants without AD, defined at T1 or reliable changes RCI [ 57 ]?
Can specific psychopathological profiles be identified e. Can specific combinations of treatment modules be identified e.
Treatment of Children With Peer Related Aggressive Behavior
Do children in OHC respond to treatment similarly to children who live with their natural parents, or can specific moderators of treatment response be identified? What are the prevalence rates of AD in a community sample and what are the comorbidity rates in children with AD? What are the psychosocial risk and protective factors for AD and comorbid conditions in children with AD, and how are AD and comorbid conditions associated with well-being in children? What neuronal alterations of affective processing, reward processing, cognitive control and attentional functions can be identified in children with AD?
What are the relations between neurobiological markers, neuropsychological measures, real-life behavior, retrospective parental ratings and self-ratings of AD? Percentages indicate expected proportions of children with or without affective dysregulation. In addition, children who show symptoms of AD according to clinical judgment outpatient sample will also be included. In the outpatient sample, children will be enrolled by clinicians. The study centers will invite the participants and their parents to further participate in the study from T1 onwards.
If required, additional centers will be included. Patients will be treated locally at the respective study centers, with the exception of ADOPT Online, which will be provided centrally online. Responsibility for monitoring lies with the Clinical Trials Center Cologne. Treatment assignments will be displayed on screen and delivered by e-mail. The material for ADOPT Online is based on an established web-based ADHD parent-trainer [ 58 ], which is adapted from evidence-based, print-based parent self-help programs for reducing child externalizing behavior problems [ 26 , 32 , 59 ].
The content and dosage of the self-help programs have been evaluated previously [ 29 , 30 , 60 ]. While the original version of the parent-trainer focuses on changing the antecedents and consequences of problem behavior and thus aims at changing the behavioral component of AD, the modified online training combines these interventions with aspects from the mindful parenting model and with components from schema therapy.
ADOPT Online provides parents with access to three modules; the contents of these modules are interconnected, and parents can work through them in a flexible manner.
Additionally, the module leads parents to analyze individual problems with their child using videotaped examples e. Effective strategies to change behavior problems are presented e. Parents are guided to use these strategies on their child and to document the outcome. Furthermore, parents are instructed to improve the structures in their everyday life and to activate their own resources.
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In line with schema therapy, parents are guided to identify dysfunctional behavior that leads to strong negative emotions [ 67 , 68 ]. The ADOPT Online training is illustrated with sketches and short films to support social learning without direct therapist contact. The entire material will be available from the beginning of the three-month intervention period. During this three-month period, participants will receive reminders and reinforcement via automatically sent e-mails. Information about the use of the online tool will be collected from the system after participating parents have provided informed consent.
The online material will be hosted by a professional service bound to data safety and security by strict contracts that permit only the study personnel to use any data produced by the participants. The 10 modules comprise interventions to activate resources and build a positive therapeutic relationship module 1 , interventions to strengthen positive parent-child interactions module 2 and to reduce dysfunctional parenting module 3 , interventions to strengthen positive teacher-child interactions module 4 and to reduce dysfunctional teacher behavior towards the child module 5 , anger control training and training of emotion regulation module 6 , empathy training module 7 , social problem solving and social skills training module 8 , organizational skills training module 9 , and coping with trauma and negative life events module The problem of maintaining social interactions is addressed in the modification of social interactions module, in which social rules are developed in order to reduce the target problems of the child.
This module includes how to communicate effective commands, how to coach the child in social problem situations, methods for rewarding the child e. The anger control training addresses impulse control Control your anger , while the social problem-solving and social skills training aims at helping patients to develop and evaluate alternative solutions in a problem situation, as well as to train them in skillful non-verbal and verbal behavior, including role-play, video feedback, and role-reversal. Organizational skills training helps children to organize their daily tasks at home and at school.
In module 10, traumatic experiences and negative life events are identified together with the child; coping thoughts and a written narrative are developed as the basis for a gradual exposure. The interventions in module 1 and modules 6 to 10 will be supported by a smartphone app which has been developed for child psychotherapy. With the help of the app, children will be able to record therapy-relevant situations and emotions and to transfer coping strategies from therapy sessions to daily life.
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Self-management, therapeutic homework assignments, and interventions in the real-life setting Can you manage that in the real world? The teacher coaching modules 4 and 5 is also based on the THOP program, as well as the newly developed German-language School-based Coaching for Teachers of Children with Disruptive Behavior Problems SCEP [ 73 ], which is adapted from evidence-based international treatment manuals, in particular [ 74 ]. The whole treatment encompasses a total of 24 sessions. The indication for each module will be operationalized and the decision for the personalized combination of the modules will be documented.
The CBT modules will be combined according to the specific problems of the child e. In children with severe ADHD, the clarification of an indication for psychopharmacological treatment by an external physician will be recommended.
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Whenever pharmacological treatment is recommended according to current treatment guidelines, these interventions will be decided upon and fully carried out by the clinical physicians of the respective participating patient, independent from the study personnel. No treatment condition is deemed unacceptable on ethical grounds. TAU as control condition provides information about the additional benefit compared to usual care. As there is no gold standard in the treatment of AD, an active treatment as a comparator is not feasible. Within TAU, all psychosocial, psychotherapeutic and pharmacological interventions will be documented.
Decisions on possible pharmacological treatment will lie with the attending physician and will not be altered due to the study. As the online intervention will be the same for all participants, no strategies to improve treatment fidelity are necessary. In ADOPT Treatment and ADOPT Institution, treatment fidelity will be assured by i training in manualized treatment procedures, ii a structured protocol completed by therapists after each session, and iii supervision of behavior therapy by senior supervisors, either face to face or by telephone.
Behavior therapies will be supervised after every four treatment sessions, including a review of at least two videotaped sessions. Measurements will take place according to a specified schedule.
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Immediately after the initial investigation T0, screening , the first measurement T1 will occur, which involves an examination of inclusion and exclusion criteria.