The effectiveness of parent-child interaction therapy in the Netherlands: Preliminary results of a randomized controlled trial.

Objective.– This presentation provides preliminary results from a randomized controlled trial (RCT) examining the effectiveness of Parent-Child Interaction Therapy (PCIT) for Dutch families. Method.– Although data collection is not finished already, fifty families were eligible for treatment in a community mental health setting. Children's mean age was 4.8 years and 33 children were boys (62%). Most of them were randomly assigned to PCIT or Creative Family Therapy (treatment as usual; TAU). The standard, non-time limited PCIT was conducted by the trained therapists. Pre and post-treatment measures included questionnaires (Child Behavior Checklist, Eyberg Child Behavior Inventory) and observations from the Dyadic Parent Child Interaction Coding System. Results.– Pre and post-treatment data of 20 families and six-month follow-up data of 15 families were analyzed. So far, eight families dropped out. Conclusion.– Though preliminary, results of the ongoing RCT will be discussed and will indicate if PCIT is an effective treatment modality for families in the Netherland

Parent-child interaction therapy for preschool children with disruptive behaviour problems in the Netherlands

Background\ud Persistent high levels of aggressive, oppositional and impulsive behaviours, in the early lives of children, are significant risk factors for adolescent and adult antisocial behaviour and criminal activity. If the disruptive behavioural problems of young children could be prevented or significantly reduced at an early age, the trajectory of these behavioural problems leading to adolescent delinquency and adult antisocial behaviour could be corrected. Parent–Child Interaction Therapy (PCIT) is a short-term, evidence-based, training intervention for parents dealing with preschool children, who exhibit behavioural problems. Recently, PCIT was implemented in a Dutch community mental health setting. This present study aims to examine the short-term effects of PCIT on reducing the frequency of disruptive behaviour in young children. \ud \ud Methods\ud This study is based on the data of 37 referred families. Whereby the results of which are derived from an analysis of parent reports of the Eyberg Child Behavior Inventory (ECBI), obtained during each therapeutic session. Furthermore, demographic information, extracted from client files, was also utilized. However, it must be noted that eleven families (27.5%) dropped out of treatment before the treatment protocol was completed. To investigate the development of disruptive behaviour, a non-clinical comparison group was recruited from primary schools (N = 59). \ud \ud Results\ud The results of this study indicate that PCIT significantly reduces disruptive behaviour in children. Large effect sizes were found for both fathers and mothers reported problems (d = 1.88, d = 1.99, respectively), which is similar to American outcome studies. At post treatment, no differences were found concerning the frequency of behavioural problems of children who completed treatment and those who participated in the non-clinical comparison group. \ud \ud Conclusion\ud The findings of this study suggest that PCIT is potentially an effective intervention strategy for young children and their parents in the Dutch population. However, further research into the evaluation of PCIT using a randomised controlled trial is recommendable\u

Key factors in children's competence to consent to clinical research

Background: Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. Methods: From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Results: Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P∈∈0.05). Conclusions: Age is the factor that explaines most of to the variance in children's competence to consent, followed by intelligence. Experience with disease did not affect competence in this study, nor did other variables. Clinical trial registration: Development and use of a standardized instrument for assessing children's competence to consent in drug trials: Are legally established age limits valid?, NTR3918

EMDR for children with medically related subthreshold PTSD: short-term effects on PTSD, blood-injection-injury phobia, depression and sleep

Background: Paediatric illness, injury and medical procedures are potentially traumatic experiences with a range of possible negative psychosocial consequences. To prevent psychosocial impairment and improve medical adherence, evidence-based psychotherapy should be offered if indicated. Eye movement desensitization and reprocessing (EMDR) has been found to reduce symptoms of posttraumatic stress disorder (PTSD) in adults. The evidence for the use with children is promising. Furthermore, recent studies indicate its effectiveness for the treatment of other psychological symptomatology. However, the effectiveness of EMDR in children with subthreshold PTSD after medically related trauma has not yet been investigated. Objective: Investigating the short-term effectiveness of EMDR on posttraumatic stress, anxiety, depression and sleep problems in children with subthreshold PTSD after hospitalization through a randomized controlled trial (RCT). Method: Following baseline screening of 420 children from various Dutch hospitals, 74 children (4–15 years old) with medically related subthreshold PTSD were randomized to EMDR (n = 37) or care-as-usual (CAU; n = 37). Follow-up assessment took place after M = 9.7 weeks. Generalized Estimating Equation (GEE) analyses were performed to examine the effectiveness of EMDR compared to CAU. Results: Children in both groups improved significantly over time on all outcomes. However, the EMDR group improved significantly more as to child-reported symptoms of blood-injection-injury (BII) phobia and depression, and child-, and parent-reported sleep problems of the child. There was no superior effect of EMDR compared to CAU on subthreshold PTSD symptom reduction. Conclusions: EMDR did not perform better than CAU in reducing PTSD symptoms in a paediatric sample of children with subthreshold PTSD after hospitalization. However, the study results indicate that EMDR might be superior in reducing symptoms of blood-injection-injury phobia, depression and sleep problems

Eye movement desensitization and reprocessing (EMDR) in children and adolescents with subthreshold PTSD after medically related trauma: design of a randomized controlled trial.

Background: Three in every 10 children and adolescents admitted to a hospital or undergoing medical treatment develop subthreshold symptoms of posttraumatic stress disorder (PTSD). When untreated, subthreshold PTSD can have a serious impact on psychosocial functioning, quality of life and long-term psychopathology. However, research investigating subthreshold PTSD and its treatment following paediatric medical interventions and/or hospitalization is scarce. Eye Movement Desensitization and Reprocessing (EMDR) is a fast and non-invasive psychosocial treatment for posttraumatic stress complaints. However, the effectiveness of EMDR in paediatric patients with subthreshold PTSD has not previously been systematically investigated. Objective: Describing the design of a randomized controlled trial (RCT) set up to evaluate the effectiveness of EMDR in children with subthreshold PTSD after hospitalization. Method: Children aged 4–15 years who have undergone a one-time (trauma type I) or repeated (trauma type II) hospitalization up to five years ago will be included. Participating children will be first screened with a standardized questionnaire for PTSD-symptoms. Subsequently, children with subthreshold PTSD will be randomly assigned to (1) approximately six sessions of standardized EMDR or (2) care as usual (CAU). Children with full diagnostic PTSD do not participate in the RCT, but are referred for direct treatment. Follow-up measurements will take place after eight weeks and eight months. Discussion: Considering the scarce evidence for the effectiveness of EMDR in children with medically related trauma, clinicans, researchers and children treated in hospitals can benefit from this study. Potential strengths and limitations of this study are discussed. Trial Registration: Netherlands Trial Register NTR580

The effectiveness of parent–child interaction therapy in the Netherlands: Preliminary results of a randomized controlled trial

Objective.– This presentation provides preliminary results from a randomized controlled trial (RCT) examining the effectiveness of Parent-Child Interaction Therapy (PCIT) for Dutch families. Method.– Although data collection is not finished already, fifty families were eligible for treatment in a community mental health setting. Children's mean age was 4.8 years and 33 children were boys (62%). Most of them were randomly assigned to PCIT or Creative Family Therapy (treatment as usual; TAU). The standard, non-time limited PCIT was conducted by the trained therapists. Pre and post-treatment measures included questionnaires (Child Behavior Checklist, Eyberg Child Behavior Inventory) and observations from the Dyadic Parent Child Interaction Coding System. Results.– Pre and post-treatment data of 20 families and six-month follow-up data of 15 families were analyzed. So far, eight families dropped out. Conclusion.– Though preliminary, results of the ongoing RCT will be discussed and will indicate if PCIT is an effective treatment modality for families in the Netherland

Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research

Background: For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Discussion: Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Summary: Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children's competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated