Victims of Child Abuse Dropping Out of Trauma-Focused Treatment: A Meta-Analysis of Risk Factors.

A substantial number of children who experienced child maltreatment drop out of evidence-based trauma-focused treatments (TF-CBT). Identifying child, family, and treatment-related factors associated with treatment dropout is important to be able to prevent this from happening and to effectively treat children's trauma-related symptoms. Methods: A quantitative review was performed based on a systematic synthesis of the literature on potential risk factors for dropout of trauma-focused treatment in maltreated children. Results: Eight studies were included, that examined TF-CBT, reporting on 139 effects of potential risk factors for dropout. Each factor was classified into one of ten domains. Small but significant effects were found for the "Demographic and Family" risk domain (r = .121), with factors including being male, child protective services involvement or placement, and minority status, and for the "Youth Alliance" risk domain (r = .207), with factors including low therapist-child support and low youth perception of parental approval. Moderator analyses suggested that family income and parental education may better predict the risk for TF-CBT dropout than other variables in the "Demographic and Family" domain. Conclusions: Our results provide a first overview of risk factors for dropout of trauma-focused treatments (TF-CBT) after child maltreatment, and highlight the role of the therapeutic relationship in this. Supplementary Information: The online version contains supplementary material available at 10.1007/s40653-022-00500-2.

Medical decision-making competence regarding puberty suppression: perceptions of transgender adolescents, their parents and clinicians.

According to international transgender care guidelines, transgender adolescents should have medical decision-making competence (MDC) to start puberty suppression (PS) and halt endogenous pubertal development. However, MDC is a debated concept in adolescent transgender care and little is known about the transgender adolescents', their parents', and clinicians' perspectives on this. Increasing our understanding of these perspectives can improve transgender adolescent care. A qualitative interview study with adolescents attending two Dutch gender identity clinics (eight transgender adolescents who proceeded to gender-affirming hormones after PS, and six adolescents who discontinued PS) and 12 of their parents, and focus groups with ten clinicians was conducted. From thematic analysis, three themes emerged regarding transgender adolescents' MDC to start PS: (1) challenges when assessing MDC, (2) aspects that are considered when assessing MDC, and (3) MDC's relevance. The four criteria one needs to fulfill to have MDC-understanding, appreciating, reasoning, communicating a choice-were all, to a greater or lesser extent, mentioned by most participants, just as MDC being relative to a specific decision and context. Interestingly, most adolescents, parents and clinicians find understanding and appreciating PS and its consequences important for MDC. Nevertheless, most state that the adolescents did not fully understand and appreciate PS and its consequences, but were nonetheless able to decide about PS. Parents' support of their child was considered essential in the decision-making process. Clinicians find MDC difficult to assess and put into practice in a uniform way. Dissemination of knowledge about MDC to start PS would help to adequately support adolescents, parents and clinicians in the decision-making process.

Perceptions on the function of puberty suppression of transgender adolescents who continued or discontinued treatment, their parents, and clinicians.

Purpose: Treatment of transgender adolescents with puberty suppression (PS) was developed to provide time for exploration before pursuing gender affirming medical treatment (GAMT) with irreversible effects. It may also result in a more satisfactory physical outcome for those who continue with GAMT. Despite being the current first choice treatment, little research has examined the function of PS from the perspectives of transgender adolescents, their parents, and clinicians. Insight into the perceived functions of PS will help to adequately support adolescents in their decision-making process and give them the care they need. Methods: Qualitative study using interviews with eight transgender adolescents who proceeded with GAMT after PS ("continuers"), six adolescents who discontinued PS ("discontinuers") and 12 parents, and focus groups with ten clinicians. Results: All informants considered inhibition of development of secondary sex characteristics an important function of PS. Most continuers saw PS as the first step of GAMT. Nevertheless, some were glad that the effects were reversible even if they didn't expect to change their minds. Some discontinuers did experience PS as an expanded diagnostic phase. One continuer used the time on PS to get used to living in the affirmed gender role, and several parents found the time helpful to adapt to their child's new gender role. PS provided clinicians more time for diagnostic assessment. Conclusions: Adolescents, parents and clinicians do not all report the same functions of PS. Although international guidelines emphasize providing time for exploration of gender identity as an important reason for PS, many adolescents nowadays seem to have clear ideas about their gender identity and treatment wishes, and experience PS as the first step of GAMT. For some discontinuers however, PS offered a valued period of exploration. Guidelines could be modified to provide more customized care, taking adolescents' and parents' ideas about the functions of PS into account.

Mental health screening and assessment tools for forcibly displaced children: a systematic review.

Background: An unprecedentedly large number of people worldwide are forcibly displaced, of which more than 40 percent are under 18 years of age. Forcibly displaced children and youth have often been exposed to stressful life events and are therefore at increased risk of developing mental health issues. Hence, early screening and assessment for mental health problems is of great importance, as is research addressing this topic. However, there is a lack of evidence regarding the reliability and validity of mental health assessment tools for this population. Objective: The aim of the present study was to synthesise the existing evidence on psychometric properties of patient reported outcome measures [PROMs] for assessing the mental health of asylum-seeking, refugee and internally displaced children and youth. Method: Systematic searches of the literature were conducted in four electronic databases: MEDLINE, PsycINFO, Embase and Web of Science. The methodological quality of the studies was examined using the COSMIN Risk of Bias checklist. Furthermore, the COSMIN criteria for good measurement properties were used to evaluate the quality of the outcome measures. Results: The search yielded 4842 articles, of which 27 met eligibility criteria. The reliability, internal consistency, structural validity, hypotheses testing and criterion validity of 28 PROMs were evaluated. Conclusion: Based on the results with regard to validity and reliability, as well as feasibility, we recommend the use of several instruments to measure emotional and behavioural problems, PTSD symptoms, anxiety and depression in forcibly displaced children and youth. However, despite a call for more research on the psychometric properties of mental health assessment tools for forcibly displaced children and youth, there is still a lack of studies conducted on this topic. More research is needed in order to establish cross-cultural validity of mental health assessment tools and to provide optimal cut-off scores for this population. HIGHLIGHTS Research on the psychometric properties of mental health screening and assessment tools for forcibly displaced children and youth is slowly increasing.However, based on the current evidence on the validity and reliability of screening and assessment tools for forcibly displaced children, we are not able to recommend a core set of instruments. Instead, we provide suggestions for best practice.More research of sufficient quality is important in order to establish crsoss-cultural validity and to provide optimal cut-off scores in mental health screening and assessment tools for different populations of forcibly displaced children and youth.

Antecedentes: Un número sin precedentes de personas en todo el mundo son desplazadas por la fuerza, de las cuales más del 40 por ciento son menores de 18 años. Los niños y jóvenes desplazados por la fuerza a menudo han estado expuestos a eventos vitales estresantes y, por lo tanto, corren un mayor riesgo de desarrollar problemas de salud mental. Por lo tanto, la detección temprana y la evaluación de los problemas de salud mental son de gran importancia, al igual que la investigación que aborda este tema. Sin embargo, hay una falta de evidencia con respecto a la confiabilidad y validez de las herramientas de evaluación de la salud mental para esta población.Objetivo: El objetivo del presente estudio fue sintetizar la evidencia existente sobre las propiedades psicométricas de los instrumentos de medición de resultado reportadas por el paciente [PROM, por sus siglas en inglés] para evaluar la salud mental de los niños y jóvenes solicitantes de asilo, refugiados y desplazados internos.Método: Se realizaron búsquedas sistemáticas de la literatura en cuatro bases de datos electrónicas: MEDLINE, PsycINFO, Embase y Web of Science. La calidad metodológica de los estudios se examinó mediante la lista de verificación de riesgo de sesgo de COSMIN. Además, se utilizaron los criterios COSMIN de buenas propiedades de medición para evaluar la calidad de los instrumentos de medición de resultados.Resultados: La búsqueda arrojó 4842 artículos, de los cuales 27 cumplieron con los criterios de elegibilidad. Se evaluaron la confiabilidad, consistencia interna, validez estructural, prueba de hipótesis y validez de criterio de 28 PROM.Conclusión: En base a los resultados con respecto a la validez y confiabilidad, así como la factibilidad, recomendamos el uso de varios instrumentos para medir problemas emocionales y de conducta, síntomas de TEPT, ansiedad y depresión en niños y jóvenes desplazados por la fuerza. Sin embargo, a pesar de la petición de más investigación sobre las propiedades psicométricas de las herramientas de evaluación de la salud mental para niños y jóvenes desplazados por la fuerza, todavía faltan estudios sobre este tema. Se necesita más investigación para establecer la validez transcultural de las herramientas de evaluación de la salud mental y proporcionar puntajes de corte óptimos para esta población.

Common elements of evidence-based trauma therapy for children and adolescents.

Background: Numerous evidence-based trauma therapies for children and adolescents have been developed over several decades to minimize the negative outcomes of post-traumatic stress disorder (PTSD). However, PTSD remains a complex construct and is associated with pervasive problems and high comorbidity. To gain more insight, much could be learnt from the similarities in trauma therapies. Objective: The purpose of this study is to derive common elements from evidence-based trauma therapies for children and adolescents. Method: Therapies were selected from a literature search. Five evidence-based trauma therapies were included in this study. A common element list was created through an existing and modified Delphi method, with a diverse group of Dutch trauma therapists. An element was deemed common when it appeared in three or more of the therapies. The final list was presented to international experts on the included trauma therapies. Results: A substantial commonality of techniques and mechanisms was found across the five evidence-based trauma therapies for children and adolescents, showing a strong overlap between therapies. Conclusion: The identified elements create a basis for research and clinical practice, with regard to targeted trauma therapies tailored to each individual child and his or her support system. This promotes therapy modules that are more flexible and accessible for both therapists and clients, in every environment, from specialized psychiatric units to sites with meagre resources. With current integrated knowledge, we can enhance the effectiveness of child psychiatry and refine trauma therapies. HIGHLIGHTS: Using a modified Delphi method, a substantial commonality of techniques and mechanisms is found in evidence-based trauma therapies for children and adolescents.Understanding the techniques and mechanisms of trauma therapy could be of help in refining upcoming therapies, and creates a basis for future research.Commonalities promote therapy modules that are more flexible and accessible for both therapists and clients, in environments ranging from specialized psychiatric units to sites with meagre resources.

Antecedentes: Una gran cantidad de evidencia relativa a terapias basadas en la evidencia para el trauma en niños y adolescentes se ha desarrollado en las últimas décadas, con el fin de minimizar los resultados negativos del TEPT. Sin embargo, el TEPT sigue siendo un constructo complejo y asociado con problemas generalizados, y una alta comorbilidad. Para obtener más información, se podría aprender mucho de las similitudes entre las terapias para el trauma. Por lo tanto, el propósito de este artículo es derivar elementos comunes de las terapias basadas en evidencia para el trauma en niños y adolescentes.Método: Las terapias fueron seleccionadas a partir de una búsqueda bibliográfica. En este estudio se incluyeron cinco terapias de trauma basadas en la evidencia. Se creó una lista de elementos comunes a través de un método Delphi existente y modificado, con un grupo diverso de terapeutas de trauma holandeses. Un elemento se consideró como común cuando apareció en tres o más de las terapias. La lista final se presentó a expertos internacionales de las terapias de trauma incluidas.Resultados y conclusión: Se encontró una coincidencia sustancial de técnicas y mecanismos en las cinco terapias de trauma basadas en la evidencia para niños y adolescentes, lo que muestra una fuerte superposición entre las terapias. Los elementos identificados crean una base para la investigación y la práctica clínica con respecto a las terapias de trauma específicas adaptadas a cada niño individual y su sistema de apoyo. Esto promueve módulos de terapia que son más flexibles y accesibles tanto para terapeutas como para clientes en cualquier entorno, desde unidades psiquiátricas especializadas hasta sitios con escasos recursos. Con el conocimiento integrado actual podemos mejorar la eficacia de la psiquiatría infantil y refinar las terapias de trauma.

Assessing Medical Decision-Making Competence in Transgender Youth.

BACKGROUND: According to international transgender care guidelines, an important prerequisite for puberty suppression (PS) is transgender adolescents' competence to give informed consent (IC). In society, there is doubt whether transgender adolescents are capable of this, which in some countries has even led to limited access to this intervention. Therefore, this study examined transgender adolescents' medical decision-making competence (MDC) to give IC for starting PS in a structured, replicable way. Additionally, potential associated variables on MDC, such as age, intelligence, sex, psychological functioning, were investigated. METHODS: A cross-sectional semistructured interview study with 74 transgender adolescents (aged 10-18 years; 16 birth-assigned boys, 58 birth-assigned girls) within two Dutch specialized gender-identity clinics was performed. To assess MDC, judgements based on the reference standard (clinical assessment) and the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), a validated semistructured interview, were used. RESULTS: Of the transgender adolescents, 93.2% (reference standard judgements; 69 of 74) and 89.2% (MacCAT-T judgements; 66 of 74) were assessed competent to consent. Intermethod agreement was 87.8% (65 of 74). Interrater agreements of the reference standard and MacCAT-T-based judgements were 89.2% (198 of 222) and 86.5% (192 of 222), respectively. IQ and sex were both significantly related to MacCAT-T total score, whereas age, level of emotional and behavioral challenges, and diagnostic trajectories duration were not. CONCLUSIONS: By using the MacCAT-T and clinicians' assessments, 93.2% and 89.2%, respectively, of the transgender adolescents in this study were assessed competent to consent for starting PS.

Breaking bad news: what parents would like you to know.

OBJECTIVE: Breaking bad news about life-threatening and possibly terminal conditions is a crucial part of paediatric care for children in this situation. Little is known about how the parents of children with life-threatening conditions experience communication of bad news. The objective of this study is to analyse parents' experiences (barriers and facilitators) of communication of bad news. DESIGN: A qualitative study consisting of a constant comparative analysis of in-depth interviews conducted with parents. SETTING: The Netherlands. PARTICIPANTS: Sixty-four parents-bereaved and non-bereaved-of 44 children (aged 1-12 years, 61% deceased) with a life-threatening condition. INTERVENTIONS: None. RESULTS: Based on parents' experiences, the following 10 barriers to the communication of bad news were identified: (1) a lack of (timely) communication, (2) physicians' failure to ask parents for input, (3) parents feel unprepared during and after the conversation, (4) a lack of clarity about future treatment, (5) physicians' failure to voice uncertainties, (6) physicians' failure to schedule follow-up conversations, (7) presence of too many or unknown healthcare professionals, (8) parental concerns in breaking bad news to children, (9) managing indications of bad news in non-conversational contexts, and (10) parents' misunderstanding of medical terminology. CONCLUSIONS: This study shows healthcare professionals how parents experience barriers in bad news conversations. This mainly concerns practical aspects of communication. The results provide practical pointers on how the communication of bad news can be improved to better suit the needs of parents. From the parents' perspective, the timing of conversations in which they were informed that their child might not survive was far too late. Sometimes, no such conversations ever took place.

Dealing with Moral Challenges in Treatment of Transgender Children and Adolescents: Evaluating the Role of Moral Case Deliberation.

Treatment teams providing affirmative medical transgender care to young people frequently face moral challenges arising from the care they provide. An adolescent's capacity to consent, for example, could raise several issues and challenges. To deal with these challenges more effectively, several Dutch treatment teams started using a relatively well-established form of clinical ethics support (CES) called Moral Case Deliberation (MCD). MCD is a facilitator-led, collective moral inquiry based on a real case. This study's purpose is to describe the teams' perceived value and effectiveness of MCD. We conducted a mixed methods evaluation study using MCD session reports, individual interviews, focus groups, and MCD evaluation questionnaires. Our results show that Dutch transgender care providers rated MCD as highly valuable in situations where participants were confronted with moral challenges. The health care providers reported that MCD increased mutual understanding and open communication among team members and strengthened their ability to make decisions and take action when managing ethically difficult circumstances. However, the health care providers also expressed criticisms of MCD: some felt that the amount of time spent discussing individual cases was excessive, that MCD should lead to more practical and concrete results, and that MCD needed better integration and follow-up in the regular work process. We recommend future research on three matters: studying how MCD contributes to the quality of care, involvement of transgender people themselves in MCD, and integration of CES into daily work processes.

Accuracy of the Diagnostic Infant and Preschool Assessment (DIPA) in a Dutch sample.

BACKGROUND: To prevent negative effects of early-onset psychiatric disorders on children's development, structured diagnostics are needed. However, validated diagnostic instruments (based on DSM-5) for children aged 7 years and younger are scarce. The Diagnostic Infant and Preschool Assessment (DIPA) is a diagnostic interview developed in the USA for measuring 16 psychiatric disorders in young children. The psychometric properties of the American version of the DIPA have been validated. Here we determined the accuracy of the psychometric properties of the Dutch DSM-5 based version of the DIPA for the corresponding population. MATERIAL AND METHODS: Psychometric properties of the DSM-5 based version of the DIPA were determined based on a sample of 136 biological, foster, therapeutic foster and adoptive parents of clinically referred children and children involved in a serious accident (aged 1-7 years). In line with the American validation study, we included the following seven DIPA modules: posttraumatic stress disorder (PTSD), major depressive disorder (MDD), attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), separation anxiety disorder (SAD), generalized anxiety disorder (GAD), and obsessive-compulsive disorder (OCD). We administered the DIPA, Trauma Symptom Checklist for Young Children (TSCYC) and Child Behavior Checklist (CBCL). Analyses were conducted with continuous outcomes (number of symptoms) and categorical outcomes (diagnoses). RESULTS: The Dutch DSM-5 based version of the DIPA showed good internal consistency and interrater reliability with both continuous and categorical variables. The concurrent validity was good; we found a good concordance between the DIPA and corresponding questionnaires on both the symptom and diagnoses level. In addition, the divergence on symptom level between the DIPA and non-corresponding questionnaires was adequate, which indicated adequate divergent validity. Due to a limited number of positive cases, we could not draw conclusions regarding its psychometric properties in the GAD and OCD modules. CONCLUSIONS: Our study shows promising initial results regarding the reliability and validity of the Dutch version of the DIPA, that is based on the DSM-5. Therefore, we recommend the use of the DIPA in research and clinical practice.

[Assessment of decision-making competence; article for educational and training purposes]. / Wilsbekwaamheid beoordelen.

Care providers are frequently confronted with complicated questions about decision-making competence. This article offers tools to help them to deal with those questions. We also look closely at the underlying legal aspects of competence, how and when competence should be assessed, who is responsible for this assessment and which tools are available for this process.

Increasing Resource Parents' Sensitivity towards Child Posttraumatic Stress Symptoms: a Descriptive Study on a Trauma-Informed Resource Parent Training.

Resource parents are often insufficiently prepared for recognizing and managing posttraumatic stress symptoms (PTSS) in their traumatized foster children, which can put a successful foster placement at risk. The Resource Parent Curriculum (RPC) developed by the National Child Traumatic Stress Network is designed to increase resource parents' sensitivity towards child PTSS. This study explores the effect of the RPC on resource parents' recognition of child PTSS, resource parents' perceived upbringing stress in caring for their foster child, and child PTSS before entering the RPC (T0), after completing the RPC (T1) and at six-month follow-up (T2). Results (n = 108) show an increase in recognition of child PTSS and a decrease in resource parents' experienced upbringing stress and child PTSS over time. Findings suggest that the RPC increases resource parents' trauma sensitivity. However, child PTSS severity remains high. To address foster children's PTSS, child trauma-focused treatment appears needed in addition to the RPC.

Medical decision-making in children and adolescents: developmental and neuroscientific aspects.

BACKGROUND: Various international laws and guidelines stress the importance of respecting the developing autonomy of children and involving minors in decision-making regarding treatment and research participation. However, no universal agreement exists as to at what age minors should be deemed decision-making competent. Minors of the same age may show different levels of maturity. In addition, patients deemed rational conversation-partners as a child can suddenly become noncompliant as an adolescent. Age, context and development all play a role in decision-making competence. In this article we adopt a perspective on competence that specifically focuses on the impact of brain development on the child's decision-making process. MAIN BODY: We believe that the discussion on decision-making competence of minors can greatly benefit from a multidisciplinary approach. We adopted such an approach in order to contribute to the understanding on how to deal with children in decision-making situations. Evidence emerging from neuroscience research concerning the developing brain structures in minors is combined with insights from various other fields, such as psychology, decision-making science and ethics. Four capacities have been described that are required for (medical) decision-making: (1) communicating a choice; (2) understanding; (3) reasoning; and (4) appreciation. Each capacity is related to a number of specific skills and abilities that need to be sufficiently developed to support the capacity. Based on this approach it can be concluded that at the age of 12 children can have the capacity to be decision-making competent. However, this age coincides with the onset of adolescence. Early development of the brain's reward system combined with late development of the control system diminishes decision-making competence in adolescents in specific contexts. We conclude that even adolescents possessing capacities required for decision-making, may need support of facilitating environmental factors. CONCLUSION: This paper intends to offer insight in neuroscientific mechanisms underlying the medical decision-making capacities in minors and to stimulate practices for optimal involvement of minors. Developing minors become increasingly capable of decision-making, but the neurobiological development in adolescence affects competence in specific contexts. Adequate support should be offered in order to create a context in which minors can make competently make decisions.

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. 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.

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). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (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.

Why do children decide not to participate in clinical research: a quantitative and qualitative study.

BACKGROUND: More pediatric drug trials are needed, but although specific pediatric regulations warrant safety, recruitment of children for these trials remains one of the main difficulties. Therefore, we investigated potential determining factors of nonparticipation in clinical research, in order to optimize research participation of children by recommending improved recruitment strategies. METHODS: Between 1 January 2012 and 1 January 2014, we performed a prospective study among161 pediatric patients, aged 6 to 18 y, who were eligible for clinical research. We quantitatively analyzed the association of potential explanatory variables (e.g., age, cognitive development, experience, ethnicity) with nonparticipation and qualitatively analyzed interviews on reasons for nonparticipation. RESULTS: Sixty percent of the children did not participate in the research project on offer (39% decided not to participate, 21% were indecisive). Lower age, less disease experience, and less complex research with lower risk were predictive for not participating. Time constraint and extra burden were expressed as decisive reasons for not participating. CONCLUSIONS: Strategies to optimize research participation should be aimed at younger children and their families, who are logistically challenged and unfamiliar with health care and research. Recommendations include informing pediatric patients and their families of the value of research; minimizing logistic burdens; and improving accessibility.

Feasibility of an Assessment Tool for Children's Competence to Consent to Predictive Genetic Testing: a Pilot Study.

Knowledge on children's capacities to consent to medical treatment is limited. Also, age limits for asking children's consent vary considerably between countries. Decision-making on predictive genetic testing (PGT) is especially complicated, considering the ongoing ethical debate. In order to examine just age limits for alleged competence to consent in children, we evaluated feasibility of a standardized assessment tool, and investigated cutoff ages for children's competence to consent to PGT. We performed a pilot study, including 17 pediatric outpatients between 6 and 18 years at risk for an autosomal dominantly inherited cardiac disease, eligible for predictive genetic testing. The reference standard for competence was established by experts trained in the relevant criteria for competent decision-making. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) served as index test. Data analysis included raw agreement between competence classifications, difference in mean ages between children judged competent and judged incompetent, and estimation of cutoff ages for judgments of competence. Twelve (71 %) children were considered competent by the reference standard, and 16 (94 %) by the MacCAT-T, with an overall agreement of 76 %. The expert judgments disagreed in most cases, while the MacCAT-T judgments agreed in 65 %. Mean age of children judged incompetent was 9.3 years and of children judged competent 12.1 years (p = .035). With 90 % sensitivity, children younger than 10.0 years were judged incompetent, with 90 % specificity children older than 11.8 years were judged competent. Feasibility of the MacCAT-T in children is confirmed. Initial findings on age cutoffs are indicative for children between the age of 12 and 18 to be judged competent for involvement in the informed consent process. Future research on appropriate age-limits for children's alleged competence to consent is needed.

Why is it hard to make progress in assessing children's decision-making competence?

BACKGROUND: For decades, the discussion on children's competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children's interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children's competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children's competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children's medical decision-making competence. DISCUSSION: Understanding children's competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child's decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children's competency, in which the most prominent question concerns the lack of a clear operationalization of children's competence to consent. Empirical data are needed to substantiate the discussion. SUMMARY: The empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research.

IMPORTANCE: An objective assessment of children's competence to consent to research participation is currently not possible. Age limits for asking children's consent vary considerably between countries, and, to our knowledge, the correlation between competence and children's age has never been systematically investigated. OBJECTIVES: To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. DESIGN, SETTING, AND PARTICIPANTS: This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. EXPOSURES: Competence judgments by experts aware of the 4 relevant criteria-understanding, appreciation, reasoning, and choice-were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. MAIN OUTCOMES AND MEASURES: Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. RESULTS: Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver operating characteristics curve, 0.90). In children younger than 9.6 years, competence was unlikely (sensitivity, 90%); in those older than 11.2 years, competence was probable (specificity, 90%). The optimal cutoff age was 10.4 years (sensitivity, 81%; specificity, 84%). CONCLUSIONS AND RELEVANCE: The MacCAT-CR demonstrated strong psychometric properties. In children aged 9.6 to 11.2 years, consent may be justified when competence can be demonstrated in individual cases by the MacCAT-CR. The results contribute to a scientific underpinning of regulations for clinical research directed toward children.

Assessing children's competence to consent in research by a standardized tool: a validity study.

BACKGROUND: Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children's competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. METHODS/DESIGN: In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130-190 subjects, providing a minimum of 10-15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. DISCUSSION: A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children's competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies.