Quantitative and Qualitative Exploration of Meaningful Change on the Vineland Adaptive Behavior Scales (Vineland™-II) in Children and Adolescents with Autism Without Intellectual Disability Following Participation in a Clinical Trial.

Purpose: The VinelandTM Adaptive Behavior Scale is often used in autism spectrum disorder (ASD) trials. The Adaptive Behavior Composite Score (VABS-ABC) is the standardized overall score (the average of the Socialization, Communication and Daily Living skills domains), and the standardized 2-Domain Composite Score (VABS-2DC) is a novel outcome measure (average of the Socialization and Communication domains). A within-person meaningful change threshold (MCT) has not been established for the VABS-2DC. This paper presents a quantitative and qualitative interpretation of what constitutes a meaningful change in these scores to individuals with ASD without Intellectual Disability (ID; IQ≥70) and their families, as reported by their study partners (SPs). Participants and Methods: Data were obtained from the aV1ation clinical trial in children and adolescents with ASD and associated exit interviews. The intent-to-treat (ITT) clinical trial population included 308 individuals with autism (85.4% male; average age: 12.4 years [standard deviation (SD)=2.97]); 124 in the child cohort (aged 5 to 12 years; average age: 9.4 years [SD=1.86]), and 184 in the adolescent cohort (aged 13 to 17 years; average age: 14.5 years [SD=1.39]). Study partners of 86 trial participants were included in the Exit Interview Population (EIP): participants represented were 83.7% male, average age: 12.3 years [SD=2.98]). Anchor and distribution-based methods were used to estimate within-person change to support a responder definition, to aid interpretation of the clinical trial data; qualitative data were used to contextualize the meaning of changes observed. Results: A within-person MCT range of 4 to 8 points was proposed for both VABS-ABC and VABS-2DC, which was associated with at least a 1-point improvement on 4 different anchors. Evidence for this within-person MCT was further supported by qualitative data, which suggested any change was considered meaningful to the individual with ASD, as reported by their SP, no matter what the magnitude. Conclusion: A change in standardized score of 4 to 8 points constitutes a within-person MCT on both VABS-ABC and novel VABS-2DC in those with ASD and no ID. A change of this, or more, was reported by the SPs in this trial to be meaningful and highly impactful upon the individuals with ASD and their family.

A Critical Appraisal of the Evidence Supporting the Factor Structure of Extant Coping Instruments.

This paper evaluated the evidence supporting the factor structure of extant coping instruments based on modern psychometric standards. Our literature search identified nine coping instruments that are routinely used to measure coping strategies in adult populations. While nearly 10 thousand papers have been published using these instruments, only 39 studies have investigated their psychometric validity. Our findings revealed that the majority of these studies did not follow current psychometric recommendations for establishing internal validity in part because they did not account for the ordinal nature of the data. Further, studies employing exploratory factor analysis used methods for identifying the number of factors to retain that have been found to have a low accuracy in a simulation study while those employing confirmatory factor analysis reported model fit statistics that did not meet widely accepted benchmarks. Hence, conflicting results were found within and across the nine coping instruments. Recommendations are made for improving future validation studies.

Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting.

PURPOSE: Psychometric evaluation of the Nocturia Impact (NI) Diary was conducted to support its use as a trial endpoint. METHODS: As part of a randomized, controlled Phase 2 clinical trial investigating a novel drug candidate for nocturnal polyuria, adult nocturia patients completed the NI Diary and a voiding diary for three nights preceding their clinic visit at Baseline and Weeks 1, 4, 8, and 12 (end of treatment). Exit interviews were conducted to obtain patient impressions of the NI Diary. RESULTS: A total of N = 302 participants were included. Confirmatory factor analysis (CFA) indicated that the 11-item measure is unidimensional with values of CFI, TLI, and RMSEA meeting relevant thresholds. Good internal consistency (Cronbach's α 0.941) and test-retest reliability (intra-class correlation coefficients 0.730-0.880). Convergent validity with two reference measures was demonstrated with strong correlations of 0.573-0.730 were shown. Significant differences (P = 0.0018, standardized effect size = 0.372) between groups defined by number of night-time voids supported known-groups validity. Exit interviews in 66 patients indicated all participants experienced improvement in at least 1 NI Diary item and that a 1-point improvement on the item response scale and 1-void reduction per night (associated with an average best cut point on ROC analysis of - 11.6) constituted meaningful improvement. Anchor and distribution-based analyses identified a meaningful change threshold of - 15 to - 18 points on the NI Diary. CONCLUSION: The NI Diary is a reliable and valid patient-reported psychometric instrument which is fit-for-purpose to evaluate the impact of nocturia on patient quality of life in the clinical trial setting. Trial registration number and registration date NCT03201419; June 28, 2017.

Pilot Validation Study on the Tavistock Relationships Observational Scale for the Assessment of the Quality of Dyadic Relationships in Couples in Which One Partner Has Dementia.

BACKGROUND AND PURPOSE: Many people with dementia are cared for by their spouses. Poor quality of the dyadic relationship is a known risk factor for carer burden and mistreatment of the person with dementia. This study aimed to design and cross validate the Tavistock Relationships Observational Scale (TROS) for assessment of the quality of the relationship in such couples. METHODS: The study was conducted within the context of the therapeutic intervention with n = 11 couples. Couples' video-recorded interactions were assessed independently by three psychologists using the 13-item TROS. RESULTS: Cronbach alphas of the scale computed for the three raters were in the range 0.76-0.88 (on average 0.83), thus demonstrating high internal consistency of the scale. Fleiss Kappa coefficient for the three rates computed for 22 assessed videos ranged between 0.45 (moderate agreement) and 0.85 (almost perfect agreement) with 50% of coefficients being above 0.50, suggesting the good performance of the TROS in terms of yielding a satisfactory inter-rater agreement. The TROS also showed good external validity when using as validation criteria caregiving partner's burden (measured with the Zarid Burden Interview: the scales Social burden [Rho = -0.65, p = 0.021] and Role strain [Rho = -0.68, p = 0.014]), depression of the person with dementia (measured with the Cornell Scale for Depression in Dementia: Rho = -0.78, p = 0.020), and relationship satisfaction of the caregiving partner (measured with the dyadic adjustment scale: Rho = 0.52, p = 0.038). The TROS also showed a good capacity to detect the change in scores from time 1 to time 2; moreover, power analysis showed that the TROS can detect the change in scores even in very small samples (n = 5 couples). CONCLUSIONS: The TROS may be a useful tool for a standardized assessment of the quality of dyadic relationships in couples with dementia in research, nursing, or clinical settings to assist clinical psychologist, nurses, or social workers in a preliminary evaluation of the situation of couples with dementia, to choose a suitable care or intervention, to assess the effectiveness of interventions focusing on improvement of dyadic relationships, or to assess the risk of spousal abuse or neglect of a person with dementia.

How do the prevalence and relative risk of non-suicidal self-injury and suicidal thoughts vary across the population distribution of common mental distress (the p factor)? Observational analyses replicated in two independent UK cohorts of young people.

OBJECTIVES: To inform suicide prevention policies and responses to youths at risk by investigating whether suicide risk is predicted by a summary measure of common mental distress (CMD (the p factor)) as well as by conventional psychopathological domains; to define the distribution of suicide risks over the population range of CMD; to test whether such distress mediates the medium-term persistence of suicide risks. DESIGN: Two independent population-based cohorts. SETTING: Population based in two UK centres. PARTICIPANTS: Volunteers aged 14-24 years recruited from primary healthcare registers, schools and colleges, with advertisements to complete quotas in age-sex-strata. Cohort 1 is the Neuroscience in Psychiatry Network (n=2403); cohort 2 is the ROOTS sample (n=1074). PRIMARY OUTCOME MEASURES: Suicidal thoughts (ST) and non-suicidal self-injury (NSSI). RESULTS: We calculated a CMD score using confirmatory bifactor analysis and then used logistic regressions to determine adjusted associations between risks and CMD; curve fitting was used to examine the relative prevalence of STs and NSSI over the population distribution of CMD. We found a dose-response relationship between levels of CMD and risk of suicide. The majority of all subjects experiencing ST and NSSI (78% and 76% in cohort 1, and 66% and 71% in cohort 2) had CMD scores no more than 2 SDs above the population mean; higher scores indicated the highest risk but were, by definition, infrequent. Pathway mediation models showed that CMD mediated the longitudinal course of both ST and NSSI. CONCLUSIONS: NSSI and ST in youths reflect CMD that also mediates their persistence. Universal prevention strategies reducing levels of CMD in the whole population without recourse to screening or measurement may prevent more suicides than approaches targeting youths with the most severe distress or with psychiatric disorders.

Personality dimensions emerging during adolescence and young adulthood are underpinned by a single latent trait indexing impairment in social functioning.

BACKGROUND: Personality with stable behavioural traits emerges in the adolescent and young adult years. Models of putatively distinct, but correlated, personality traits have been developed to describe behavioural styles including schizotypal, narcissistic, callous-unemotional, negative emotionality, antisocial and impulsivity traits. These traits have influenced the classification of their related personality disorders. We tested if a bifactor model fits the data better than correlated-factor and orthogonal-factor models and subsequently validated the obtained factors with mental health measures and treatment history. METHOD: A set of self-report questionnaires measuring the above traits together with measures of mental health and service use were collected from a volunteer community sample of adolescents and young adults aged 14 to 25 years (N = 2443). RESULTS: The bifactor model with one general and four specific factors emerged in exploratory analysis, which fit data better than models with correlated or orthogonal factors. The general factor showed high reliability and validity. CONCLUSIONS: The findings suggest that a selected range of putatively distinct personality traits is underpinned by a general latent personality trait that may be interpreted as a severity factor, with higher scores indexing more impairment in social functioning. The results are in line with ICD-11, which suggest an explicit link between personality disorders and compromised interpersonal or social function. The obtained general factor was akin to the overarching dimension of personality functioning (describing one's relation to the self and others) proposed by DSM-5 Section III.

The association between paternal and adolescent depressive symptoms: evidence from two population-based cohorts.

BACKGROUND: Incidence of depression increases markedly around age 13 years, and nearly three-quarters of adults report that their mental health problems started in adolescence. Although maternal depression is a risk factor for adolescent depression, evidence about the association between paternal and adolescent depression is inconclusive, and many studies have methodological limitations. We aimed to assess the association between paternal and adolescent depressive symptoms in two large population-based cohort studies. METHODS: We used data for two-parent families from two representative prospective cohorts in Ireland (Growing up in Ireland [GUI]) and the UK (Millennium Cohort Study [MCS]). Parental depressive symptoms were measured with the Centre for Epidemiological Studies Depression Scale in the GUI cohort when children were 9 years old, and the Kessler six-item psychological distress scale in the MCS cohort when children were 7 years old. Adolescent depressive symptoms were measured with the Short Mood and Feelings Questionnaire (SMFQ) at age 13 years in the GUI cohort and age 14 years in the MCS cohort. We analysed data using linear regression models, before and after adjustment for confounders, in both multiply imputed and complete case samples. FINDINGS: There were 6070 families in GUI and 7768 in MCS. After all adjustments, a 1 SD (three-point) increase in paternal depressive symptoms was associated with an increase of 0·24 SMFQ points (95% CI 0·03-0·45; p=0·023) in the GUI cohort and 0·18 SMFQ points (0·01-0·36; p=0·041) in the MCS cohort. This association was independent of, and not different in magnitude to, the association between maternal and adolescent depressive symptoms (Wald test p=0·435 in the GUI cohort and 0·470 in the MCS cohort). INTERPRETATION: Our results show an association between depressive symptoms in fathers and depressive symptoms in their adolescent offspring. These findings support the involvement of fathers as well as mothers in early interventions to reduce the prevalence of adolescent depression, and highlight the importance of treating depression in both parents. FUNDING: Department of Children and Youth Affairs and Economic and Social Research Council.

The role of timing of maltreatment and child intelligence in pathways to low symptoms of depression and anxiety in adolescence.

Research indicates that childhood maltreatment is strongly associated with high levels of adolescent depression and anxiety symptoms. Using LONGSCAN data and taking into account the range of family characteristics related to adversity (poverty, primary caregiver substance abuse) and protective factors (living with biological mother and father), the present study assessed the complex resilience process in which child intelligence (age 6) mediated the relationship between early childhood maltreatment (age 0-4) and adolescent symptoms of depression and anxiety (age 14). We also assessed if mid (age 6-8) and late (age 10-12) childhood maltreatment moderated this mediation. We found that mid-childhood intelligence mediated the negative effect of early childhood maltreatment (age 0-4) on anxiety symptoms (age 14), but not on depressive symptoms (age 14). We also found the effect of timing of maltreatment: early childhood maltreatment (age 0-4) predicted more anxiety symptoms in adolescence, whereas late childhood/early adolescent (age 10-12) maltreatment predicted more symptoms of depression in adolescence. In addition, mid (age 6-8) and late (age 10-12) childhood maltreatment dampened the protective effect of IQ (age 6) against anxiety (age 14). In sum, current evidence shows that low anxiety and depression symptoms in adolescence following childhood maltreatment was achieved through different pathways, and that early and late childhood/early adolescence were more sensitive periods for development of psychopathology related to depression and anxiety in adolescence.