Moving forward. Use of the START NOW skills training program for female youth with ODD and CD - a commentary on Stadler et al. (2024).

Female youth with oppositional defiant disorder (ODD) and conduct disorder (CD) are an under studied and underserved population at high risk for poor adjustment in later life. Stadler et al. (2024) attempt to redress this situation for adolescent females with CD or ODD with an adapted version of the skills training program START NOW. They describe the results of an ambitious randomized control trial, comparing START NOW with standard care in youth welfare settings in Germany, Switzerland, and The Netherlands. The findings appear promising, but the paper is especially valuable for the spotlight it shines on the needs of this underserved population and those caring for them, together with the importance of undertaking such trials despite their challenges. This commentary seeks to encourage readers to engage with the START NOW trial.

For Which Children with ADHD is TBR Neurofeedback Effective? Comorbidity as a Moderator.

We examined psychiatric comorbidities moderation of a 2-site double-blind randomized clinical trial of theta/beta-ratio (TBR) neurofeedback (NF) for attention deficit hyperactivity disorder (ADHD). Seven-to-ten-year-olds with ADHD received either NF (n = 84) or Control (n = 58) for 38 treatments. Outcome was change in parent-/teacher-rated inattention from baseline to end-of-treatment (acute effect), and 13-month-follow-up. Seventy percent had at least one comorbidity: oppositional defiant disorder (ODD) (50%), specific phobias (27%), generalized anxiety (23%), separation anxiety (16%). Comorbidities were grouped into anxiety alone (20%), ODD alone (23%), neither (30%), or both (27%). Comorbidity (p = 0.043) moderated acute effect; those with anxiety-alone responded better to Control than to TBR NF (d = - 0.79, CI - 1.55- - 0.04), and the other groups showed a slightly better response to TBR NF than to Control (d = 0.22 ~ 0.31, CI - 0.3-0.98). At 13-months, ODD-alone group responded better to NF than Control (d = 0.74, CI 0.05-1.43). TBR NF is not indicated for ADHD with comorbid anxiety but may benefit ADHD with ODD.Clinical Trials Identifier: NCT02251743, date of registration: 09/17/2014.

The impact of a guided paced breathing audiovisual intervention on anxiety symptoms in Palestinian children: a pilot randomized controlled trial.

BACKGROUND: Children in Palestine may be at high risk for anxiety symptoms. However, access to mental health services is limited. Therefore, the objective of this study was to conduct a pilot randomized controlled trial to examine whether a guided audiovisual paced breathing intervention was feasible, acceptable, and improved anxiety symptoms in Palestinian children. METHODS: Students (6-10 years old) in an after-school program in Palestine were randomly assigned to the intervention or control condition. All participants completed a pre- and post-intervention measure of anxiety using the Revised Children's Manifest Anxiety Scale. Participants in the intervention completed 24 sessions over 8 weeks and rated breathing ease as well as pre- and post-session relaxation on a 5-point Likert scale. To examine condition differences in post-intervention anxiety, four analyses of covariance were conducted, adjusting for age, sex, and pre-intervention anxiety. RESULTS: A total of 144 participants (65.3% girls; Mage  = 7.5 ± 1.2; 50% per condition) enrolled in the study. There were no differences in demographics or baseline anxiety between the two conditions (ps > .05). Participants reported that it was easy to breathe during the sessions (Ms = 4.1-4.7, SDs = 0.5-1.1). For all but the first session, participants reported being more relaxed after the breathing session than before (ps < .003). Post-intervention, participants in the intervention reported fewer anxiety symptoms compared to participants in the control condition (ps < .01). CONCLUSION: A guided paced breathing audiovisual intervention was feasible and had a significant positive impact on anxiety symptoms in Palestinian children compared to a control condition. Future research should examine whether the audiovisual guided breathing intervention significantly improves long-term outcomes.

Destigmatizing perceptions about Black adolescent depression: randomized controlled trial of brief social contact-based video interventions.

OBJECTIVE: To test the utility of brief social contact-based video interventions of a Black adolescent girl to reduce stigmatized attitudes and increase help-seeking intentions around adolescent depression. METHODS: We conducted a randomized controlled trial (RCT) with 14- to18-year-old healthy volunteers drawn from the general US population. We enrolled participants through a crowdsourcing platform (n = 1,093) and randomly assigned participants to one of three video conditions (117 s each): depressed (DEP); depressed, adjusted to aspects unique to being a Black adolescent girl (including experienced or internalized racism; ADJ); and control (CONT). The primary outcome was the Depression Stigma Scale (DSS); secondary outcomes were the General Health-Seeking Questionnaire (GHSQ), and thermometers for Black and white race perception "warmth". RESULTS: Following the intervention, the DSS changed from baseline across the three conditions (p < .001). ADJ outperformed both DEP (p = .031) and CONT (p < .001). A race-by-intervention interaction (p < .001) revealed different response profiles between Black (ADJ = DEP = CONT; p = .726) and non-Black participants (ADJ > DEP > CONT; p < .001). DEP and ADJ both resulted in higher treatment-seeking intentions for both the emotional problems and the suicidal thought subscales of the GHSQ. We found a race-by-intervention interaction (p = .01) for the Black thermometer, which revealed a significant 2° increase in warmth among white (p < .001), but not Black, viewers (p = .06). CONCLUSIONS: On a short-term basis, brief social contact-based videos proved effective among adolescents in reducing depression-related stigma, increasing help-seeking intentions, and providing an "empathic foothold" in the lives of racially stigmatized groups. Even as the enduring effects of these interventions remain to be determined, the deployment on social media of short videos opens new opportunities to reach a large number of at-risk youth."

Online-delivered parenting intervention for young children with disruptive behavior problems: a noninferiority trial focused on child and parent outcomes.

BACKGROUND: This study evaluated whether an evidence-based parenting intervention, when delivered online, could effectively address disruptive behavior problems in young children and yield outcomes comparable to in-person delivery of the same intervention. METHODS: Families (n = 334) of children (3-7 years; 63% White, 22% African American, 15% other races; 63% male) with disruptive behavior problems were randomized to online-delivered intervention (ODI) or staff-delivered intervention (SDI), resulting in baseline and demographic equivalence. Primary outcome measures for child disruptive behavior (independent observation, parent report) and secondary outcome measures of parenting and family impact were assessed at baseline, postintervention, and follow-up. Conducted using intent-to-treat (ITT) as well as per-protocol (PP) methods, noninferiority analyses, which drew on an HLM framework with repeat measures across three timepoints and on REML to provide unbiased estimates of model parameters, tested whether the outcome-difference CI did not exceed the a priori noninferiority margin. RESULTS: For ITT and PP analyses, the ODI was found to be noninferior to the SDI on the primary outcome: independently observed child disruptive behavior and parent-reported child behavior problems. The pattern for secondary outcomes was more varied: (a) noninferiority for observed positive and aversive parenting; (b) noninferiority for observed quality of parent-child relationship at post but not follow-up assessment; (c) noninferiority for parent-reported inappropriate/inconsistent discipline for PP but not ITT analyses; and (d) noninferiority not confirmed for parenting daily hassles and adverse family quality of life, despite large effect sizes for the ODI (Cohen's d .75-1.07). Finally, ODI noninferiority was found for teacher-reported child disruptive behavior. CONCLUSIONS: The tested online-delivered parenting intervention demonstrated clear noninferiority with the corresponding staff-delivered parenting intervention on the primary outcome, child disruptive behavior problems, and reflected substantial though nonuniform noninferiority and meaningful effect sizes for secondary outcomes related to parenting and family. Future research will guide optimization of online interventions.

Sleeping Sound Autism Spectrum Disorder (ASD): a randomised controlled trial of a brief behavioural sleep intervention in primary school-aged autistic children.

BACKGROUND: Behavioural sleep problems are common in children with autism spectrum disorder (ASD); however, evidence for the efficacy of behavioural sleep interventions is limited. This study examined the efficacy of a brief behavioural sleep intervention in autistic children. It was hypothesised that the intervention would reduce overall child sleep problems (primary outcome), in addition to improvements in children's social, emotional, cognitive, academic functioning, and quality of life, and parent/caregivers' stress, quality of life, and mental health (secondary outcomes). METHODS: A randomised controlled trial was conducted with participants randomised via a computer-generated sequence to the sleeping sound intervention (n = 123) or treatment as usual (n = 122) group. Participants comprised 245 children with an ASD diagnosis. Inclusion criteria were as follows: confirmation of DSM IV or DSM-5 diagnosis of ASD, participants aged between 5 and 13 years and parent/caregiver report of moderate-severe sleep problems. Exclusion criteria were as follows: parent/caregiver intellectual disability or lacking sufficient English to complete questionnaires; and child participant with co-occurring medical conditions known to impact sleep. The intervention group received the sleeping sound intervention (2 × 50-min face-to-face sessions plus follow-up phone call) by a trained clinician. RESULTS: Change in children's sleep problems was measured by the Children's Sleep Habits Questionnaire (CSHQ) at 3 months post randomisation. Parents/caregivers of children in the intervention group reported a reduction in child sleep problems at 3 months post randomisation (effect size: E.S -0.7). There were also small effects in a number of child (internalising symptoms, emotional behavioural disturbance and quality of life) and parent/caregiver (mental health, parenting stress and quality of life) outcomes; however, these did not remain significant when controlling for multiple comparisons. CONCLUSIONS: The sleeping sound ASD intervention is an efficacious and practical way to reduce sleep problems for autistic children. This brief behavioural intervention has the potential to be embedded easily into the Australian healthcare system.

Mobile Health Interventions and RCTs: Structured Taxonomy and Research Framework.

Mobile Health Interventions (MHIs) have addressed a range of healthcare challenges and have been evaluated using Randomized Controlled Trials (RCTs) to establish clinical effectiveness. Using PRISMA we conducted a systematic literature review of RCTs for MHIs and identified 70 studies which were analyzed and classified using Nickerson-Varshney-Muntermann (NVM) taxonomy. From the resultant iterations of the taxonomy, we extracted insights from the categorized studies. RCTs cover a wide range of health conditions including chronic diseases, general wellness, unhealthy practices, family planning, end-of-life, and post-transplant care. The MHIs that were utilized by the RCTs were varied as well, although most studies did not find significant differences between MHIs and usual care. The challenges for MHI-based RCTs include the use of technologies, delayed outcomes, patient recruitment, patient retention, and complex regulatory requirements. These variances can lead to a higher rate of Type I/Type II errors. Further considerations are the impact of infrastructure, contextual and cultural factors, and reductions in the technological relevancy of the intervention itself. Finally, due to the delayed effect of most outcomes, RCTs of insufficient duration are unable to measure significant, lasting improvements. Using the insights from seventy identified studies, we developed a classification of existing RCTs along with guidelines for MHI-based RCTs and a research framework for future RCTs. The framework offers opportunities for (a) personalization of MHIs, (b) use of richer technologies, and (c) emerging areas for RCTs.

Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.

RATIONALE & OBJECTIVE: Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake. STUDY DESIGN: We describe the rationale and design of the Prevention of Urinary Stones With Hydration (PUSH) Study, a randomized trial of a multicomponent behavioral intervention program to increase and maintain high fluid intake. Participants are randomly assigned (1:1 ratio) to the intervention or control arm. The target sample size is 1,642 participants. SETTING & PARTICIPANTS: Adults and adolescents 12 years and older with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of urinary stone disease and comorbid conditions precluding increased fluid intake. INTERVENTIONS: All participants receive usual care and a smart water bottle with smartphone application. Participants in the intervention arm receive a fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions. Control arm participants receive guideline-based fluid instructions. OUTCOMES: The primary end point is recurrence of a symptomatic stone during 24 months of follow-up. Secondary end points include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms. LIMITATIONS: Periodic 24-hour urine volumes may not fully reflect daily behavior. CONCLUSIONS: With its highly novel features, the PUSH Study will address an important health care problem. FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT03244189.

Annual Research Review: Immersive virtual reality and digital applied gaming interventions for the treatment of mental health problems in children and young people: the need for rigorous treatment development and clinical evaluation.

BACKGROUND: Mental health problems in children and young people are common and can lead to poor long-term outcomes. Despite the availability of effective psychological interventions for mental health disorders, only a minority of affected children and young people access treatment. Digital interventions, such as applied games and virtual reality (VR), that target mental health problems in children and young people may hold a key to increasing access to, engagement with, and potentially the effectiveness of psychological treatments. To date, several applied games and VR interventions have been specifically developed for children and young people. This systematic review aims to identify and synthesize current data on the experience and effectiveness of applied games and VR for targeting mental health problems in children and young people (defined as average age of 18 years or below). METHODS: Electronic systematic searches were conducted in Medline, PsycINFO, CINAHL, and Web of Science. RESULTS: Nineteen studies were identified that examined nine applied games and two VR applications, and targeted symptoms of anxiety, depression, and phobias using both quantitative and qualitative methodologies. Existing evidence is at a very early stage and studies vary extensively in key methodological characteristics. For applied games, the most robust evidence is for adolescent depressive symptoms (medium clinical effect sizes). Insufficient research attention has been given to the efficacy of VR interventions in children and young people. CONCLUSIONS: The evidence to date is at a very early stage. Despite the enthusiasm for applied games and VR, existing interventions are limited in number and evidence of efficacy, and there is a clear need for further co-design, development, and evaluation of applied games and VR before they are routinely offered as treatments for children and young people with mental health problems.

Targeting self-criticism in the treatment of nonsuicidal self-injury in dialectical behavior therapy for adolescents: a randomized clinical trial.

BACKGROUND: The Benefits and Barriers Model proposes both benefits and barriers associated with nonsuicidal self-injury (NSSI) and that a negative association with the self plays a key role in the initial selection of and acute motivation for NSSI. The current investigation builds upon previous findings by assessing the added benefit of targeting self-criticism in the treatment of NSSI. METHODS: Sample included 40 participants (30 females; Mage  = 14.92) enrolled in dialectical behavior therapy for adolescents within a partial hospitalization program. All study participants received dialectical behavior therapy for adolescents, and those randomized to the experimental condition received an additional brief cognitive intervention developed to decrease self-criticism. RESULTS: There was no evidence of an indirect effect of targeting self-criticism upon NSSI at post-treatment via post-treatment self-criticism (b = -0.98, p = .543); however, there was evidence of a significant interaction between treatment condition and self-criticism at pretreatment in the prediction of NSSI at post-treatment (b = 0.33, p = .030). Analyses of simple slopes indicated the conditional direct effect of targeting self-criticism varied as a function of patient's level of self-criticism at the onset of treatment, such that individuals -1 SD below the mean (b = -5.76, p = .037) and at average pretreatment levels of self-criticism (b = -4.09, p = .042), but not + 1 SD above the mean (b = -2.42, p = .056), experienced fewer incidents of NSSI at post-treatment. CONCLUSIONS: The results of this investigation support the added benefit of targeting self-criticism in the treatment of NSSI for adolescents.

Efficacy of individualized social competence training for children with oppositional defiant disorders/conduct disorders: a randomized controlled trial with an active control group.

Patient-focused cognitive-behavioral therapy in children with aggressive behavior, which uses group-based social skills training, has resulted in significant reductions in behavioral problems, with effect sizes in the small-to-medium range. However, effects of individually delivered treatments and effects on aggressive behavior and comorbid conditions rated from different perspectives, child functional impairment, child quality of life, parent-child relationship, and parental psychopathology have rarely been assessed. In a randomized controlled trial, 91 boys aged 6-12 years with a diagnosis of oppositional defiant disorder/conduct disorder and peer-related aggression were randomized to receive individually delivered social competence training (Treatment Program for Children with Aggressive Behavior, THAV) or to an active control involving group play that included techniques to activate resources and the opportunity to train prosocial interactions in groups (PLAY). Outcome measures were rated by parents, teachers, or clinicians. Mostly moderate treatment effects for THAV compared to PLAY were found in parent ratings and/or clinician ratings on aggressive behavior, comorbid symptoms, psychosocial impairment, quality of life, parental stress, and negative expressed emotions. In teacher ratings, significant effects were found for ADHD symptoms and prosocial behavior only. THAV is a specifically effective intervention for boys aged 6-12 years with oppositional defiant disorder/conduct disorder and peer-related aggressive behavior as rated by parents and clinicians.

Detraining effects of regular Tai Chi exercise on postural control ability in older women: A randomized controlled trial.

BACKGROUND/OBJECTIVE: This study aimed to investigate the training and detraining effects of Tai Chi (TC) on postural control ability in single leg stance (SLS) by conducting a single-blind randomized controlled trial. METHOD: Forty-eight older women were randomly divided into the TC, brisk walking (BW), and control(C) groups by using computer-generated program. The participants completed a 16-week intervention training and 8-week detraining program. Postural control ability in SLS was tested at the baseline, 16 t h, 20 t h, and 24 t h weeks. The primary outcomes included single-leg stance time (Time) and secondary outcomes included maximal displacement of the center of pressure (COP) in the anterior-posterior (AP) direction (D-ap), maximal displacement of the COP in the medial-lateral (ML) direction (D-ml), total length of the COP trajectories (Lng), and 95% confidence ellipse area of the COP movements (area), mean AP total excursion velocities (V-ap), and mean ML total excursion velocities (V-ml). RESULTS: Significant within-group difference compared with the baseline and between-groups difference compared with control group were found at 16 t h, 20 t h, and 24 t h weeks in the TC group and at the 16 t h and 20 t h weeks in the BW group in all the primary and secondary outcomes. Most of secondary outcomes including Lng, D-ml, V-ml, Area increased significantly at the 24 t h week compared with that at the 16 t h week in BW group. CONCLUSIONS: TC was effective in improving postural control ability and maintaining intervention gains, and was recommended as an appropriate exercise to prevent falls in the older adults.

The efficacy of early language intervention in mainstream school settings: a randomized controlled trial.

BACKGROUND: Oral language skills are a critical foundation for literacy and more generally for educational success. The current study shows that oral language skills can be improved by providing suitable additional help to children with language difficulties in the early stages of formal education. METHODS: We conducted a randomized controlled trial with 394 children in England, comparing a 30-week oral language intervention programme starting in nursery (N = 132) with a 20-week version of the same programme starting in Reception (N = 133). The intervention groups were compared to an untreated waiting control group (N = 129). The programmes were delivered by trained teaching assistants (TAs) working in the children's schools/nurseries. All testers were blind to group allocation. RESULTS: Both the 20- and 30-week programmes produced improvements on primary outcome measures of oral language skill compared to the untreated control group. Effect sizes were small to moderate (20-week programme: d = .21; 30-week programme: d = .30) immediately following the intervention and were maintained at follow-up 6 months later. The difference in improvement between the 20-week and 30-week programmes was not statistically significant. Neither programme produced statistically significant improvements in children's early word reading or reading comprehension skills (secondary outcome measures). CONCLUSIONS: This study provides further evidence that oral language interventions can be delivered successfully by trained TAs to children with oral language difficulties in nursery and Reception classes. The methods evaluated have potentially important policy implications for early education.

In hip osteoarthritis, Nordic Walking is superior to strength training and home-based exercise for improving function.

This observer-blinded, randomized controlled trial compared the short- and long-term effects of 4 months of supervised strength training (ST) in a local fitness center, supervised Nordic Walking (NW) in a local park, and unsupervised home-based exercise (HBE, control) on functional performance in 60+-year-old persons (n = 152) with hip osteoarthritis (OA) not awaiting hip replacement. Functional performance [i.e., 30-s chair stand test (primary outcome), timed stair climbing, and 6-min walk test] and self-reported outcomes (i.e., physical function, pain, physical activity level, self-efficacy, and health-related quality of life) were measured at baseline and at 2, 4, and 12 months. Based on intention-to-treat-analyses improvements [mean (95% CI)] after intervention in number of chair stands were equal in all three groups at 4 months [ST: 0.9 (0.2-1.6), NW: 1.9 (0.8-3.0), HBE: 1.1 (0.1-2.0)] but greater in the NW group [1.4 (0.02-2.8)] than in the ST group at 12 months. Generally, improvements in functional performance were greater (P < 0.001-P < 0.03) after NW compared with HBE and ST at all follow-up time points. Furthermore, NW was superior (P < 0.01) to HBE for improving vigorous physical activity and to both ST and HBE for improving (P < 0.01) mental health. These data suggest that NW is the recommended exercise modality compared with ST and HBE.

The time-dependent "cure-death" model investigating two equally important endpoints simultaneously in trials treating high-risk patients with resistant pathogens.

A variety of primary endpoints are used in clinical trials treating patients with severe infectious diseases, and existing guidelines do not provide a consistent recommendation. We propose to study simultaneously two primary endpoints, cure and death, in a comprehensive multistate cure-death model as starting point for a treatment comparison. This technique enables us to study the temporal dynamic of the patient-relevant probability to be cured and alive. We describe and compare traditional and innovative methods suitable for a treatment comparison based on this model. Traditional analyses using risk differences focus on one prespecified timepoint only. A restricted logrank-based test of treatment effect is sensitive to ordered categories of responses and integrates information on duration of response. The pseudo-value regression provides a direct regression model for examination of treatment effect via difference in transition probabilities. Applied to a topical real data example and simulation scenarios, we demonstrate advantages and limitations and provide an insight into how these methods can handle different kinds of treatment imbalances. The cure-death model provides a suitable framework to gain a better understanding of how a new treatment influences the time-dynamic cure and death process. This might help the future planning of randomised clinical trials, sample size calculations, and data analyses.

A pilot randomized controlled trial comparing computer-assisted cognitive rehabilitation, stimulant medication, and an active control in the treatment of ADHD.

BACKGROUND: This research aimed to compare computer-assisted cognitive rehabilitation (CACR) psychostimulants (MED) and placebo CACR (PCACR) in the treatment of ADHD using a multiarm parallel design. METHODS: Thirty-four boys with ADHD, aged 7-12, were randomly assigned to either CACR (n = 12), MED (n = 11), or PCACR (n = 11). However, the study was not blinded and medication doses might be suboptimal given the lack of titration. Continuous performance test, Tower-of-London, forward/backward digit span, span board, Raven's progressive matrices, and SNAP-IV were completed at baseline, posttest, and follow-up. RESULTS: Computer-assisted cognitive rehabilitation outperformed both MED and PCACR on backward digit span at posttest and PCACR at follow-up. CACR outperformed PCACR and MED on forward digit span at posttest and PCACR at follow-up. CACR outperformed MED on span board at posttest. CACR outperformed PCACR and MED on Raven's matrices at posttest. CACR and PCACR scored lower than MED on ADHD-PHI at posttest. CACR scored lower than MED on ADHD-C at posttest. CONCLUSIONS: Immediately after interventions, CACR improved certain simple executive functions (EFs) as much as active stimulant medication. On complex EFs, CACR was superior to active stimulant medication and PCACR. CACR reduced behavioral symptoms of ADHD more than active stimulant medication. However, at 3-month follow-up, maintenance of the CACR gains was weak.

Taming the adolescent mind: a randomised controlled trial examining clinical efficacy of an adolescent mindfulness-based group programme.

BACKGROUND: Mindfulness interventions with adolescents are in the early stages of development. This study sought to establish efficacy of a mindfulness-based group intervention for adolescents with mixed mental health disorders. METHOD: One hundred and eight adolescents (ages 13-18) were recruited from community mental health clinics and randomised into two groups (control vs. treatment). All participants received treatment-as-usual (TAU) from clinic-based therapists independent of the study. Adolescents in the treatment condition received TAU plus a 5-week mindfulness-training programme (TAU+Mi); adolescents in the control group received only TAU. Assessments including parent/carer reports were conducted at baseline, postintervention and 3-month follow-up. RESULTS: At postintervention, adolescents in the mindfulness condition experienced significant decrease in mental distress (measured with the DASS-21) compared to the control group (Cohen's d = 0.43), and these gains were enhanced at 3-month follow-up (Cohen's d = 0.78). Overall outcomes at 3 months showed significant improvement for adolescents in the mindfulness condition; in self-esteem, mindfulness, psychological inflexibility and mental health, but not resilience. Parents/carers also reported significant improvement in their adolescent's psychological functioning (using the CBCL). Mediation analyses concluded mindfulness mediated mental health outcomes. CONCLUSIONS: Increase in mindful awareness after training leads to improvement in mental health and this is consistent with mindfulness theory. The mindfulness group programme appears to be a promising adjunctive therapeutic approach for clinic-based adolescents with mental health problems.

Reading and language intervention for children at risk of dyslexia: a randomised controlled trial.

BACKGROUND: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. METHODS: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. RESULTS: Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. CONCLUSIONS: This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice.

Unfavorable influence of structured exercise program on total leisure-time physical activity.

In randomized controlled trials (RCTs), with customized structured physical exercise activity (SPEA) interventions, the dose of leisure-time physical activity (LTPA) should exceed the LTPA dose of the nonexercising control (C) group. This increase is required to substantiate health improvements achievable by exercise. We aimed to compare the dose of SPEA, LTPA, and total LTPA (SPEA + LTPA) between a randomized Nordic walking (NW) group, a power-type resistance training (RT) group, and a C group during a 12-week exercise intervention in obese middle-aged men (n = 144) with impaired glucose regulation. The dose of physical activity was measured with diaries using metabolic equivalents. No significant difference (P > 0.107) between the groups was found in volume of total LTPA. The volume of LTPA was, however, significantly higher (P < 0.050) in the C group than in the NW group, but not compared with the RT group. These results indicate that structured exercise does not automatically increase the total LTPA level, possibly, as a result of compensation of LTPA with structured exercise or spontaneous activation of the C group. Thus, the dose of total LTPA and the possible changes in spontaneous LTPA should be taken into account when implementing a RCT design with exercise intervention.

Social Skills Interventions for Adolescents with Level 1 Autism Spectrum Disorder: A Systematic Review with Meta-Analysis of Randomized Controlled Trials.

Objective: Evidence on the efficacy of social skills training for adolescents with Level 1 Autism Spectrum Disorder (ASD) is unclear. Method: We searched Pubmed, Scopus, and Web of Science until July 27th, 2023, for randomized controlled trials (RCTs) of social skills training for pre-adolescents and adolescents (aged 9-18) with Level 1 ASD. We then pooled data on efficacy from individual RCTs by conducting multivariate mixed-effects meta-analyses in R. We estimated possible bias in the retained RCTs using the RoB2 tool. Results: We retained 36 RCTs (encompassing 2796 participants), including 18 RCTs comparing an experimental treatment to a waiting list, and 18 RCTs comparing it to standard care/control treatment. Meta-analyses showed that experimental treatments were significantly more efficacious than waiting list or standard care/ control treatments in improving social skills (SMD = 0.3745; 95%CI = [0.2396; 0.5093]), as well as reducing behavioral symptoms (0.3154;0.1783, 0.4525) and anxious/depressive symptoms (0.2780; 0.0432, 0.5128). However, for some outcomes there was significant heterogeneity across studies and evidence of publication bias. Subgroup analyses and meta-regressions did not identify any specific clinical or demographic factors as significant predictors of outcome. The most common risk of bias across studies was related to deviations from intended interventions and measurement of the outcomes. Conclusions: At the group level, social skills training for adolescents with Level 1 ASD is efficacious, with small-to-moderate effect size. Future research should focus on personalized medicine approaches, aimed at tailoring interventions to specific characteristics of adolescents with Level 1 ASD.