Feasibility Study of Back2School, a Modular Cognitive Behavioral Intervention for Youth With School Attendance Problems

There is large heterogeneity among youth with school attendance problems (SAPs). For this reason, protocols for the treatment of SAPs need to be flexible. Back2School (B2S) is a new manual-based, modular transdiagnostic cognitive behavioral intervention to increase school attendance among youth with SAPs. It also aims to increase the self-efficacy of these youth and their parents. B2S includes evidence-based modules addressing youth anxiety, depression, and behavior problems, together with modules focused on parent guidance and school consultation. The current study examined the feasibility of evaluating B2S in an randomized controlled trial and acceptability of the B2S program in a non-randomized trial, including both qualitative and quantitative data, in preparation for a randomized controlled trial of its effectiveness. Youth, parents, and teachers completed questionnaires at baseline, post-intervention, and follow-up. School attendance data were collected from school registers. Twenty-four youth with a SAP (defined as more than 10% absenteeism during the last 3 months) were recruited from primary and lower secondary schools in Aarhus Municipality, Denmark. Their parents also participated in B2S. Two of the 24 families withdrew during the intervention, after sessions two and six respectively. Of the remaining 22 families, 19 (86%) completed all 10 sessions. Parents and youth rated their satisfaction with B2S as high, and high levels of satisfaction were maintained 1 year after the intervention. Teacher satisfaction was lower than that of youth and parents, but the majority found the school's participation in the intervention helpful. Preliminary evaluation of intervention outcomes showed significant increase in school attendance and decrease in psychological symptoms, as well as a significant increase in self-efficacy for both youth and parents. Based on this feasibility data, adaptations were made to the B2S manual and study procedures prior to commencement of a randomized controlled effectiveness trial. The main adaptation to the manual was to increase school consultation. The main procedural adaptation was to broaden recruitment. Furthermore, it was necessary to increase level of staffing by psychologists because treatment delivery was more time consuming than expected.Pathways through Adolescenc

Psychotic experiences are associated with health anxiety and functional somatic symptoms in preadolescence

Background: Health anxiety (HA) is an increasing public health problem related to increased health service costs, and associated with functional somatic symptoms (FSS) and considerable personal suffering. Abnormal bodily experiences which may resemble HA and FSS are common in psychotic disorders, but a potential link between HA and psychosis vulnerability in childhood is largely unexplored. The current study estimates the association between subclinical psychotic experiences (PE) and HA and FSS in a general population cohort of preadolescents. Methods: The study population consisted of 1,572 11–12-year-old children from the Copenhagen Child Cohort 2000. PE were comprehensibly assessed as either present or not present using the Kiddie Schedule of Affective Disorders and Schizophrenia psychosis section. HA and FSS were assessed by self-report on validated questionnaires. Additional variables on general psychopathology, puberty, and chronic somatic illness were also obtained. Results: Psychotic experiences were associated with the top 10% high scores of HA (Odds Ratio (OR) 3.2; 95% CI: 2.1–4.8) and FSS (OR 4.6; 95% CI: 3.1–6.9) in univariate analyses. After mutual adjustment, the association was reduced to (HA: OR 2.3; 95% CI: 1.5–3.5; FSS: OR 3.7; 95% CI: 2.4–4.7), suggesting interdependence. Further adjustment for potential confounders and general psychopathology only reduced the associations slightly: HA OR 2.2 (95% CI: 1.4–3.4); FSS OR 3.3 (95% CI: 2.1–5.2). Secondary analyses of subdimensions of HA showed that PE were associated with fears (OR 3.0; 95% CI: 2.0–4.6) and daily impact of HA symptoms (OR 5.0; 95% CI: 3.4–7.5), but not help seeking (OR 1.2; 95% CI: 0.7–2.1). Conclusions: This is the first study to investigate the associations between PE and HA and FSS, respectively. PE were significantly associated with HA and FSS over and above general psychopathology in preadolescence. Individuals with PE expressed high levels of health-related fears and daily impact, but no corresponding help-seeking behavior

The predictive validity of the Strengths and Difficulties Questionnaire in preschool age to identify mental disorders in preadolescence

The Strengths and Difficulties Questionnaire (SDQ) is a brief, widely used instrument to screen for mental health problems in children and adolescents. The SDQ predictive algorithms developed for the SDQ, synthesize information from multiple informants regarding psychiatric symptoms and their impact on daily life. This study aimed to explore the validity of the SDQ predictive algorithms used in preschool age to predict mental disorders in preadolescence. The study population comprises 1176 children from the Copenhagen Child Cohort 2000 (CCC2000) assessed at age 5-7 years by the SDQ and reassessed at 11-12 years with the Development and Well Being Assessment (DAWBA) for evaluation of ICD-10 mental disorders. Odds Ratios (ORs), sensitivities, specificities, positive predictive values (PPVs) and negative predictive values (NPVs) were calculated for the SDQ predictive algorithms regarding ICD-10 diagnoses of hyperkinetic-inattentive-, behavioural- and emotional disorders. Significant ORs ranging from 2.3-36.5 were found for the SDQ predictive algorithms in relation to the corresponding diagnoses. The highest ORs were found for hyperkinetic and inattentive disorders, and the lowest for emotional disorders. Sensitivities ranging from 4.5-47.4, specificities ranging from 83.0-99.5, PPVs ranging from 5.0-45.5 and NPVs ranging from 90.6-99.0 were found for the SDQ predictive algorithms in relation to the diagnoses. The results support that the SDQ predictive algorithms are useful for screening at preschool-age to identify children at an increased risk of mental disorders in preadolescence. However, early screening with the SDQ predictive algorithms cannot stand alone, and repeated assessments of children are needed to identify, especially internalizing, mental health problems

Outcomes of a 12-week ecologically valid observational study of first treatment with methylphenidate in a representative clinical sample of drug naïve children with ADHD

Randomized placebo-controlled trials have reported efficacy of methylphenidate (MPH) for Attention-deficit/hyperactivity disorder (ADHD); however, selection biases due to strict entry criteria may limit the generalizability of the findings. Few ecologically valid studies have investigated effectiveness of MPH in representative clinical populations of children. This independently funded study aims to describe treatment responses and their predictors during the first 12 weeks of MPH treatment using repeated measurements of symptoms and adverse reactions (ARs) to treatment in 207 children recently diagnosed with ADHD. The children were consecutively included from the Child and Adolescent Mental Health Centre, Mental Health Services, The Capital Region of Denmark. The children (mean age, 9.6 years [range 7–12], 75.4% males) were titrated with MPH, based on weekly assessments of symptoms (18-item ADHD-rating scale scores, ADHD-RS-C) and ARs. At study-end 187 (90.8%) children reached a mean end-dose of 1.0 mg/kg/day. A normalisation/borderline normalisation on ADHD-RS-C was achieved for 168 (81.2%) children on the Inattention and/or the Hyperactivity-Impulsivity subscale in week 12, and 31 (15.0%) children were nonresponders, which was defined as absence of normalisation/borderline normalisation (n = 19) or discontinuation due to ARs (n = 12), and eight (3.8%) children dropped out from follow-up. Nonresponders were characterised by more severe symptoms of Hyperactivity-Impulsivity and global impairment before the treatment. ARs were few; the most prominent were appetite reduction and weight loss. A decrease in AR-like symptoms during the treatment period questions the validity of currently available standard instruments designed to measure ARs of MPH. This ecologically valid observational study supports prior randomized placebo-controlled trials; 81.2% of the children responded favourably in multiple domains with few harmful effects to carefully titrated MPH. Clinical trial registration: ClinicalTrials.gov with registration number NCT04366609

The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>The Danish OPUS I trial randomized 547 patients with first-episode psychosis to a two-year early-specialised assertive treatment programme (OPUS) versus standard treatment. The two years OPUS treatment had significant positive effects on psychotic and negative symptoms, secondary substance abuse, treatment adherence, lower dosage of antipsychotic medication, and a higher treatment satisfaction. However, three years after end of the OPUS treatment, the positive clinical effects were not sustained, except that OPUS-treated patients were significantly less likely to be institutionalised compared with standard-treated patients. The major objective of the OPUS II trial is to evaluate the effects of five years of OPUS treatment versus two years of OPUS treatment.</p> <p>Methods</p> <p>The OPUS II trial is designed as a randomized, open label, parallel group trial with blinded outcome assessment. Based on our sample size estimation, 400 patients treated in OPUS for two years will be randomized to further three years of OPUS treatment versus standard treatment. The specialized assertive OPUS treatment consists of three core elements: assertive community treatment, psycho-educational family treatment, and social skills training.</p> <p>Discussion</p> <p>It has been hypothesized that there is a critical period from onset up to five years, which represents a window of opportunity where a long-term course can be influenced. Extending the specialized assertive OPUS treatment up to five years may allow the beneficial effects to continue beyond the high-risk period, through consolidation of improved social and functional outcome.</p> <p>Trial registration</p> <p>Clinical Trial.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00914238">NCT00914238</a></p

A Psychometric Evaluation of the Danish Version of the Theory of Mind Storybook for 8-14 Year-Old Children

Background: Theory-of-Mind (ToM) keeps on developing in late childhood and early adolescence, and the study of ToM development later in childhood had to await the development of sufficiently sensitive tests challenging more mature children. The current study aimed to investigate the psychometric properties of the Danish version of the Theory-of-Mind Storybook Frederik (ToM-Frederik). Methods: We assessed whether ToM-Frederik scores differed between a group of 41 typically developing (TD) children and a group of 33 children with High Functioning Autism Spectrum Disorder (HFASD). A lower mean ToM Frederik score was expected in the HFASD group. To determine the convergent validity of ToM-Frederik, potential associations with Strange Stories and Animated Triangles (AT) were analyzed. Furthermore, potential associations between ToM-Frederik and the Social Responsiveness Scale (SRS) and between ToM Frederik and the Social Emotional Evaluation (SEE) Total score were analyzed. Results: A significantly higher ToM-Frederik score was observed in the TD group compared to the HFASD group. Furthermore, the convergent validity of ToM-Frederik as a measure of ToM was supported by significant and positive associations with the Strange Stories and the AT scores in the HFASD group, whereas ToM-Frederik was significantly correlated with Strange Stories, but not with AT in the TD group. ToM-Frederik was not significantly associated with SRS in neither the HFASD nor the TD group. Conclusion: The findings are supportive of ToM-Frederik as a valid indicator of deficits at the group level in children with HFASD between 7 and 14 years of age. Furthermore, the convergent validity is supported

The Future of Child and Adolescent Clinical Psychopharmacology: A Systematic Review of Phase 2, 3, or 4 Randomized Controlled Trials of Pharmacologic Agents Without Regulatory Approval or for Unapproved Indications

The pace of development and implementation of novel medications in child and adolescent psychiatry has remained slow. We systematically searched https://clinicaltrials.gov/ and https://www.clinicaltrialsregister.eu/ (from 01/01/2010 to 08/23/2022) for phase 2 or 3 randomized controlled trials (RCTs) of medications without regulatory approval in the US, Europe or Asia. We also included RCTs of dietary interventions/probiotics. Additionally, we searched phase 4 RCTs of agents targeting unlicensed indications for children/adolescents with mental health disorders. We retrieved 234 ongoing or completed RCTs, including 26 (11%) with positive findings on ≥1 primary outcome, 43 (19%) with negative/unavailable results on every primary outcome, and 165 (70%) without publicly available statistical results. The only two compounds with evidence of significant effects that were replicated in ≥1 additional RCT without any negative RCTs were dasotraline for attention-deficit/hyperactivity disorder, and carbetocin for hyperphagia in Prader-Willi syndrome. Among other strategies, targeting specific symptom dimensions in samples stratified based on clinical characteristics or established biomarkers may increase chances of success in future development programmes