Clinical trials

The goal of this two-armed randomized controlled trial is to investigate the effectiveness of a new, individually tailored, brief behavioral training for teachers of children with behavioral difficulties at school. The main questions the study aims to answer are: * Does the brief teacher training reduce the severity of four daily rated target behaviors in specific classroom situations compared to practice as usual (PAU) on the short term? * Does the brief teacher training program reduce the severity of the same four daily rated target behaviors in other classroom situations, behavioral difficulties of the child at school and at home, and the impairment of the child in the school situation and reduce the number of behavioral difficulties of the child at school judged as troublesome by the teacher, and improve the teacher-student relationship quality, teachers' sense of efficacy, and teachers' behavior management strategies compared to practice as usual (PAU) on the short term? * Are short-term improvements maintained at 3 months follow-up? Teachers will be randomly assigned (simple randomization) to (a) three sessions of brief teacher training with PAU, or (b) PAU only. The brief teacher training provides teachers with individually tailored stimulus control and contingency management techniques to treat children's behavioral difficulties in two (bi)weekly training sessions of two hours and a third session of one hour in which the training will be evaluated and maintenance training will be provided. PAU may include any support or treatment as regularly provided by mental health care centers, schools, school collaborations and/or other organizations, except from pharmacological treatment for children's behavioral difficulties and/or behavioral teacher training/support. PAU can also imply that there is no support or treatment.

The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are: 1. What are the expectations of children and adolescents and therapists with VR exposure? 2. What is the acceptability of the VR session (positive and negative effects)? 3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR.

RATIONALE: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. OBJECTIVES: This project aims to increase the effective use of parent training for children with behavioral difficulties by (1) examining short and longer-term effectiveness of a new, brief, individual, and individually-tailored parent training program with optional booster sessions to prevent relapse, compared to care as usual (CAU); (2) assessing the cost-effectiveness of the brief parent training program compared to CAU. STUDY DESIGN: In this two-arm, multi-center randomized controlled trial (RCT), parents are randomly assigned (1:1 ratio) to either (a) three sessions of brief behavioral parent training with optional booster sessions, or (b) CAU, as regularly provided by the involved mental healthcare centers. The study outcomes are measured at baseline before randomization (T0), one week after the third session for parents in the brief behavioral parent training arm and eight weeks after T0 for parents in the CAU arm (first posttreatment measurement, T1), six months after T1 (second posttreatment measurement, T2) and twelve months after T1 (third posttreatment measurement, T3). STUDY POPULATION: Parents of children who experience behavioral difficulties in the home setting and were referred to a child mental healthcare center. INTERVENTION: Parents in the intervention arm receive a short, individualized, three-session training primarily aimed at reducing children's behavioral problems. It exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual. Parents in the control arm receive care as usual for children's behavioral problems. The treatments in both arms are fully embedded in Dutch routine mental health care. MAIN STUDY PARAMETERS: The primary outcome is the severity of four individual target behavioral difficulties that parents want to address in the training. Secondary outcomes are parent-reported behavioral difficulties, parent-reported child well-being, parent-reported parenting behaviors, masked audio records of mealtime routines to measure parent and child behavior, parent-reported parenting stress, parent-reported parenting self-efficacy, parent-reported parental attitude towards their child, consumption and cost of mental health care, and health state utility values. We furthermore measure evaluations of the program by parents and therapists and explore whether parental attachment, parental psychopathology, parental reward responsivity, parent-reported child reward responsivity and punishment sensitivity moderate the intervention effects.