Caroline J. Kistin

Pilot Studies: A Critical but Potentially Misused Component of Interventional Research.

Pilot intervention studies, commonly defined as small studies carried out in preparation for larger investigations,1 are essential precursors to high-quality clinical trials. Although not all trials are preceded by pilot investigations, when they are, pilot studies inform how subsequent trials are conducted and have an important role in controlling the pipeline of intervention development and dissemination by influencing which large-scale trials are ultimately carried out and which are never brought to fruition. However, pilot studies have often involved reporting inconsistencies, misapplication of research techniques, and misinterpretation of results, with significant implications for intervention research.1-3 These suboptimal research practices likely emanate from the understandable but methodologically unsound view of pilot studies as mechanisms to obtain preliminary answers to primary research questions.1-3 The risks of this approach may include unjustified and potentially misleading conclusions in the short term as well as misinformed decisions about how—and even whether—to proceed to more definitive studies.

Factors that influence the effectiveness of child protection teams.

OBJECTIVES: More than

Overstimulated Consumers or Next-Generation Learners? Parent Tensions About Child Mobile Technology Use

55 million is spent on hospital-based child protection teams (CPTs) annually, but there is no consensus on what makes CPTs effective. The objective of this study was to create expert consensus on tasks that CPTs should perform and factors that contribute to effectiveness. METHODS: A modified Delphi approach was used to create expert consensus among professionals with experience working on or with hospital-based CPTs. Three initial rounds of surveys were conducted; a first round of open-ended questions generated topics related to CPT tasks and factors related to team effectiveness. A Likert scale (range: 1–7) determined rank. In the fourth round, participants ranked the top 5 variables associated with effectiveness. RESULTS: Twenty-six (90%) of 29 participants completed the first 3 rounds, and 20 (67%) completed the final ranking. Experts believed that CPTs should provide communication of findings to appropriate agencies (mean Likert score: 7.0), court testimony (7.0), medical consultations (6.9), multidisciplinary case review (6.6), and forensic interviews (6.0). CPT success should be determined by professionals who use CPT services (6.6) and CPT members (6.5). Variables that were ranked most often as critical to effectiveness included interdisciplinary collaboration (95% of participants), provision of resources (80%), and team collegiality (75%). Variables that were ranked as most detrimental included inadequate staffing (85%) and lack of collegiality (80%). CONCLUSIONS: A multidisciplinary team working in a collegial atmosphere seems to be the major key to CPT effectiveness. In addition to providing services, CPTs should focus on improving collegiality and interdisciplinary collaboration and should seek performance feedback from referring professionals and CPT members.

Parent perspectives on their mobile technology use: the excitement and exhaustion of parenting while connected

PURPOSE Mobile technology is ubiquitous, but its impact on family life has not been thoroughly addressed in the scientific literature or in clinical practice guidelines. We aimed to understand parents’ views regarding mobile technology use by young children, aged 0 to 8 years, including perceived benefits, concerns, and effects on family interactions, with the goal of informing pediatric guidelines. METHODS We conducted 35 in-depth, semistructured group and individual interviews with English-speaking caregivers of diverse ethnic backgrounds, educational levels, and employment statuses. After thematic saturation, results were validated through expert triangulation and member checking. RESULTS Participants included 22 mothers, 9 fathers, and 4 grandmothers; 31.4% were single parents, 42.9% were of nonwhite race or ethnicity, and 40.0% completed high school or less. Participants consistently expressed a high degree of tension regarding their child’s mobile technology use, from which several themes emerged: (1) effects on the child—fear of missing out on educational benefits vs concerns about negative effects on thinking and imagination; (2) locus of control—wanting to use digital devices in beneficial ways vs feeling that rapidly evolving technologies are beyond their control (a tension more common in low-income caregivers); and (3) family stress—the necessity of device use in stressed families (eg, to control a child’s behavior or as an inexpensive learning/entertainment tool) vs its displacement of family time. CONCLUSIONS Caregivers of young children describe many novel concepts regarding use of mobile technology, raising issues not addressed by current anticipatory guidance. Guidance may be more effectively implemented if it takes into account parents’ uncertainties, locus of control, and functional uses of mobile devices in families.

A novel self-evaluation tool to assess the team function of a child protection team

Objective: Parent use of mobile devices (e.g., smartphones, tablets) while around their young children may be associated with fewer or more negative parent-child interactions, but parent perspectives regarding this issue have not been explored. We aimed to understand parent views regarding their mobile device use to identify actionable targets of potential intervention. Method: We conducted 35 in-depth semi-structured group and individual interviews with English-speaking caregivers of children 0 to 8 years old, purposively sampled from diverse ethnic backgrounds, educational levels, and employment statuses. Following thematic saturation, results were validated through expert triangulation and member checking. Results: Participants included 22 mothers, 9 fathers, and 4 grandmothers; 31% were single parents, 43% nonwhite race/ethnicity, and 40% completed high school or less. Participants consistently expressed a high degree of internal tension regarding their own mobile technology use, which centered around 3 themes relevant to intervention planning: (1) Cognitive tensions (multitasking between work and children, leading to information/role overload), (2) emotional tensions (stress-inducing and reducing effects), and (3) tensions around the parent-child dyad (disrupting family routines vs serving as a tool to keep the peace). Conclusion: Caregivers of young children describe many internal conflicts regarding their use of mobile technology, which may be windows for intervention. Helping caregivers understand such emotional and cognitive responses may help them balance family time with technology-based demands.

A qualitative study of parenting stress, coping, and discipline approaches among low-income traumatized mothers

OBJECTIVE The aim of this study was to develop a reliable and valid self-evaluation tool for use by child protection team (CPT) members. METHODS An online survey was administered to members of 10 CPTs. The survey included the following 3 sections: 1) initial conditions (eg, team composition, resources), 2) enabling conditions (eg, team effort, strategy), and 3) team effectiveness (eg, team cohesion, meeting performance standards). Each section contained multiple subscales. Internal consistency was calculated using Cronbach α. To evaluate construct validity, the subscale scores of the most advanced teams who qualified as centers of excellence (n = 3) were compared with the subscale scores of the other teams (n = 7) to determine whether the tool could distinguish between the two. RESULTS Of 116 team members, 83 (72%) completed the survey. The subscales exhibited good internal consistency (α = .71-.97). The 3 centers of excellence had significantly higher mean scores than the other 7 CPTs on the following subscales: incentives (in the initial conditions section, 61.46 vs 38.89; P = .003), effort (in the enabling conditions section, 79.31 vs 67.70; P = .003), and professional growth (in the team effectiveness section, 83.89 vs 80.40; P = .004). CONCLUSIONS This novel survey demonstrates satisfactory test characteristics and can be used to assess CPT performance and identify areas for improvement.

Transparent reporting of missing outcome data in clinical trials: applying the general principles of CONSORT 2010

Objective: The use of harsh discipline is a risk factor for child maltreatment and is more common among families in which mothers have previously experienced trauma. We sought to understand the stressors experienced by low-income traumatized mothers and the perceived impact of those stressors on their discipline approaches. Methods: We conducted 30 in-depth qualitative interviews with low-income mothers with a history of trauma. We triangulated the results with experts in behavioral health, and with a subset of the informants themselves, to ensure data reliability. Results: We identified the following themes: (1) Repetitive child behaviors are the most stressful. (2) Mothers commonly cope by taking time away; this can result in prolonged unsupervised periods for children. (3) Harsh discipline is used deliberately to prevent future behavior problems. (4) Mothers relate their childrens negative behaviors to their own past experiences; in particular, those who have suffered domestic violence fear that their children will be violent adults. Conclusions: Our findings suggest that trauma-informed interventions to promote positive discipline and prevent child maltreatment should help mothers predict and plan for stressful parent-child interactions; identify supports that will allow them to cope with stress without leaving their children for prolonged periods; and explicitly address long-term goals for their children and the impact of different discipline approaches.

Subsequent Maltreatment in Children With Disabilities After an Unsubstantiated Report for Neglect

In clinical trials, missing outcome data can be problematic, potentially introducing bias and affecting internal and external study validity.1–7 These concerns are not new. Multiple guidelines for investigators emphasise the importance of first minimising the causes of missing data, such as loss to follow-up, and then using appropriate statistical strategies to account for missing values.5 ,8–11 In spite of the increased focus on addressing missing outcome data in the design and analysis phases of clinical trials, there continues to be significant variability in how the missing data—and the related statistical analyses—are reported in the medical literature.2 ,12 Systematic reviews of published studies have found that few clinical trial reports provide a complete description of the investigators’ strategy for addressing missing outcome data,2 ,12 which can significantly impact the interpretation of study findings.1 ,3 ,4 ,6 ,7 As the recommended statistical approaches to missing data grow increasingly complex,8 ,13–15 there is more need than ever to ensure that clinical trials are reported clearly and include sufficient detail to allow readers to critically assess the underlying assumptions made by investigators. The CONSORT (Consolidated Standards of Reporting) statement,16 which was developed to improve the reporting of clinical trials, is widely used as the standard for the format and content of clinical trial reports. While the guidelines in the updated CONSORT 2010 statement only explicitly call for investigators to address missing outcome data in the …

Maternal note-taking and infant care: a pilot randomised controlled trial

Children with disabilities are at increased risk for maltreatment,1,2 and neglect accounts for the majority of such cases.3 Although most cases of suspected neglect are unsubstantiated at the time of the initial report to child protective services (CPS),4 meaning there is insufficient legal evidence of maltreatment, these children are at risk for subsequent maltreatment.5

Problem-Solving Education to Prevent Depression Among Low-Income Mothers: A Path Mediation Analysis in a Randomized Clinical Trial

Design A pilot randomised controlled trial was conducted with postpartum mothers to assess the feasibility and impact of note-taking during newborn teaching. Controls received standard teaching; the intervention group received pen and paper to take notes. Subjects were called 2 days post-discharge to assess infant sleep position, breastfeeding, car seat use, satisfaction and information recall. Results 126 mothers were randomised. There was a consistent trend that intervention subjects were more likely to report infant supine sleep position (88% vs 78%, relative risks (RR) 1.13; 95% CI 0.95 to 1.34), breastfeeding (96% vs 86%, RR 1.11; 95% CI 0.99 to 1.25) and correct car seat use (98% vs 87%, RR 1.12; 95% CI 1.00 to 1.25). Satisfaction and information recall did not differ. Among first-time mothers, intervention subjects were significantly more likely to report infant supine sleep position (95% vs 65%, RR 1.46; 95% CI 1.06 to 2.00). Conclusions Maternal note-taking is feasible and potentially efficacious in promoting desirable infant care.