The Effectiveness of an Integrated Treatment for Functional Speech Sound Disorders—A Randomized Controlled Trial

Background: The treatment of functional speech sound disorders (SSDs) in children is often lengthy, ill-defined, and without satisfactory evidence of success; effectiveness studies on SSDs are rare. This randomized controlled trial evaluates the effectiveness of the integrated SSD treatment program PhonoSens, which focuses on integrating phonological and phonetic processing according to the Integrated Psycholinguistic Model of Speech Processing (IPMSP). Methods: Thirty-two German-speaking children aged from 3.5 to 5.5 years (median 4.6) with functional SSD were randomly assigned to a treatment or a wait-list control group with 16 children each. All children in the treatment group and, after an average waiting period of 6 months, 12 children in the control group underwent PhonoSens treatment. Results: The treatment group showed more percent correct consonants (PCC) and a greater reduction in phonological processes after 15 therapy sessions than the wait-list control group, both with large effect sizes (Cohen’s d = 0.89 and 1.04). All 28 children treated achieved normal phonological abilities: 21 before entering school and 7 during first grade. The average number of treatment sessions was 28; the average treatment duration was 11.5 months. Conclusion: IPMSP-aligned therapy is effective in the treatment of SSD and is well adaptable for languages other than German.

A Digital Intervention to Alleviate Loneliness and Depression Among Older Persons During the COVID-19 Outbreak

Social distancing has been proven to be effective in reducing infections but may cause ill effects on the mental health of older adults. We evaluated the effects of a short-term virtual group intervention that provided tools to promote better coping, and mitigate adverse mental health effects during the outbreak of the covid-19 pandemic. A Randomized controlled trial tested the effects of a guided intervention comprised of seven online group sessions in which cognitive-behavioral techniques targeting maladaptive beliefs and appraisals were learned and practiced via ZOOM. A total of 82 community-dwelling adults from Israel, aged between 65 - 90 were randomized to either an intervention group (n=64) or a wait-list control group (n=18). Loneliness (UCLA loneliness scale) and depressive symptoms (PHQ-9) were measured pre-intervention, post-intervention, and at 1-month follow-up. The findings showed a significant decrease in loneliness and depression scores in the intervention group with results maintained at 1-month follow-up. There were no significant changes in the wait-list control group. In addition, ten participants (16%) from the intervention group demonstrated a clinically meaningful decrease in depression between baseline and post-intervention, and this was maintained among 7 participants (10%) at 1-month follow-up, compared to only 1 participant (5%) in the control group. Our intervention presents a simple and easy-to-implement tool. Its relevance extends beyond the current pandemic as the skills acquired can be applied in other forms of social crises and during routine life, in order to promote the mental health of older adults who live alone and/or reside in remote areas.

Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial

IntroductionNumerous studies support the practice of different physical exercise modalities as an effective treatment to address the problems associated with schizophrenia, reporting that they result in improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programmes (strength, aerobic and mixed) on the symptoms, body composition, level of physical activity and health-related quality of life of patients with schizophrenia.Methods and analysisA multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting 1 hour each, or to the wait-list control group. The training groups will complete aerobic, strength or mixed (aerobic+strength) training. The participants will be assessed before, immediately after and 6 months after the end of the intervention. The patients in the wait-list control group (n=15) will receive one of the three trainings immediately after the intervention. The study variables will include positive, negative and general symptomology (Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form) and quality of life (abbreviated WHO Quality of Life questionnaire).Ethics and disseminationThis study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia, Spain (CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.Trial registration numberNCT04987151.

Cultivating mindfulness: evaluation of a community-based mindfulness program for Arabic-speaking women in Australia

Arabic-speaking communities in Australia underutilise mental health services. Previous research with Arabic-speakers recruited individually demonstrated that an Arabic Mindfulness Compact Disc (CD) was an acceptable and useful resource for this group. Subsequently, the CD was introduced as part of a 5-week group mindfulness program for Arabic-speaking Muslim women. The intervention was delivered in a community setting by a bilingual (Arabic/English) psychologist with support from a bilingual multicultural health worker. The mixed-methods evaluation incorporated a pre–post study with a wait-list control group. An Arabic translation of the Depression Anxiety and Stress Scale (DASS21) was administered at baseline and program completion. Pre–post differences were tested using the sign test for paired samples (one-sided). Qualitative methods were used to evaluate the program’s acceptability. After five weeks, the intervention group showed statistically significant improvement on all DASS21 subscales (n = 12, p < .001 for depression and stress and p < .01 for anxiety). For the wait-list control group, only anxiety showed significant improvement (n = 8, p < .05). Qualitative analysis revealed how the women grew in their understanding of mindfulness concepts and mastered the different techniques, how they dealt with painful memories, how mindfulness practice assisted them in their daily lives, and how they related mindfulness to Islam. The in-language mindfulness intervention was shown to be culturally and spiritually relevant, and clinically effective. The group program incorporating the Arabic Mindfulness CD has potential for scaling up. Further research is required to investigate effectiveness for Arabic-speaking men with similar backgrounds.

Mindfulness-based intervention and aggression and rule-breaking behaviours in elementary school boys: a proof of concept trial

This study investigated the effect of a mindfulness-based intervention on pathological symptoms in boys with externalised disorders. A total of 24 elementary school students with externalising disorders, diagnosed by completing the Child Behavior Checklist (CBCL), were randomly assigned to a mindfulness-based intervention for two months. One session per week was offered and each session lasted one hour (n = 12) or as a wait-list control group (n = 12). Data were analysed via a multivariate analysis of covariance (MANCOVA) test. Students from the intervention group showed greater reductions in rule-breaking behaviours than those in the wait-list control group. Also, there was clear superiority of the intervention relative to the wait-list control group for reducing both aggression and rule-breaking behaviours (effect size differences were d = −2.52 and d = −1.88 respectively). These positive results on outcome measures provide initial evidence for a mindfulness-based intervention as a treatment option for boys with externalising disorders.

Combined Memory Training: An Approach for Episodic Memory Deficits in Traumatic Brain Injury

Purpose The study aimed to test a combination of semantic memory and traditional episodic memory therapies on episodic memory deficits in adults with traumatic brain injury. Method Twenty-five participants who had been diagnosed with traumatic brain injury and had episodic memory deficits were randomly assigned either to a combined memory treatment group ( n = 16) or to a wait-list control group ( n = 9). Before and after treatment, they completed standardized neuropsychological testing for episodic memory and related cognitive domains, including the California Verbal Learning Test–Second Edition, the Controlled Oral Word Association Test, the University of Southern California Repeatable Episodic Memory Test, the Wechsler Abbreviated Scale of Intelligence–Second Edition Matrices, the Test of Everyday Attention, the Memory Assessment Clinics Self-Rating Scale, the Expressive Vocabulary Test–Second Edition, and the Story Recall subtest from the Rivermead Behavioural Memory Test. In addition to a traditional episodic memory therapy, the treatment group received a novel semantic memory–focused therapy, which involved participants finding meaningful connections between diverse concepts represented by sets of two or three words. Results The treatment group demonstrated statistically significant improvement in memory for list learning tasks, and there was a significant difference from pretest to posttest between the treatment group and the wait-list control group. Clinical significance was demonstrated for the treatment group using minimally important difference calculations. Conclusion Combined memory therapy resulted in significant improvements in episodic memory, semantic memory, and attention, in comparison to no treatment. Supplemental Material https://doi.org/10.23641/asha.14049968

Effect of commercial wearables and digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas: the RAW-PA cluster-randomised controlled trial

Background There has been increasing interest in using wearable activity trackers to promote physical activity in youth. This study examined the short- and longer-term effects of a wearable activity tracker combined with digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas. Methods The Raising Awareness of Physical Activity (RAW-PA) Study was a 12-week, multicomponent intervention that combined a Fitbit Flex (and accompanying app), and online digital behaviour change resources and weekly challenges delivered via Facebook. RAW-PA was evaluated using a cluster-randomised controlled trial with 275 adolescents (50.2% female; 13.7 ± 0.4 years) from 18 Melbourne secondary schools (intervention n = 9; wait-list control group n = 9). The primary outcome was moderate- to vigorous-intensity physical activity (MVPA), measured using hip-worn ActiGraph accelerometers. The secondary outcome was self-reported physical activity. Data were collected at baseline, 12-weeks (immediately post-intervention), and 6-months post-intervention (follow-up). Multilevel models were used to determine the effects of the intervention on daily MVPA over time, adjusting for covariates. Results No significant differences were observed between intervention and wait-list control adolescents’ device-assessed MVPA immediately post-intervention. At 6-months post-intervention, adolescents in the intervention group engaged in 5 min (95% CI: − 9.1 to − 1.0) less MVPA per day than those in the wait-list control group. Males in the intervention group engaged in 11 min (95% CI: − 17.6 to − 4.5) less MVPA than males in the wait-list control group at 6-months post-intervention. No significant differences were observed for females at either time point. For self-reported physical activity, no significant effects were found at 12-weeks and 6-months post-intervention. Conclusions Combining a wearable activity tracker with digital behaviour change resources and weekly challenges did not increase inactive adolescents’ accelerometer-derived and self-reported physical activity levels immediately post-intervention. This contrasts previous research that has suggested wearable activity tracker may increase youth physical activity levels in the short-term. Lower engagement in MVPA 6-months post-intervention was observed for males but not for females, though it is unclear why this finding was observed. The results suggest wearable activity trackers, in combination with supporting materials, may not be effective for increasing physical activity levels in adolescents. Trial registration ACTRN12616000899448. Australian and New Zealand Clinical Trials Registry. Registered 7 July 2016.

DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

Formative Evaluation of a Home-Based Physical Activity Intervention for Adolescent Girls—The HERizon Project: A Randomised Controlled Trial

Background. This is a formative evaluation study of the HERizon Project, a home-based multi-component physical activity (PA) intervention for adolescent girls in the UK and Ireland. Although not intended, this study coincided with the initial COVID-19 lockdown restrictions. Methods. A total of 42 female participants, aged 13 to 16 years old (mean = 14.2, SD = 1.1), were randomly allocated to: (i) the HERizon group (n = 22) or (ii) the wait-list control group (n = 20). Participants in the six-week HERizon group were asked to complete three PA sessions each week and engage in weekly behaviour change support video calls. The primary outcome measure was self-reported habitual PA. Secondary outcomes measures included cardiorespiratory fitness (20 m shuttle run), muscular strength (standing long jump), muscular endurance (push up test), and psychosocial outcomes (Perceived Competence Scale, Body Appreciation Scale, Self-Esteem Questionnaire, Behavioural Regulation in Exercise Questionnaire). Quantitative and qualitative process evaluation data were also collected. Outcome measures were assessed at baseline and after the six-week intervention. Results. There was no significant change in habitual PA between groups (LMM group*time interaction: p = 0.767). The HERizon group had significantly increased cardiorespiratory fitness (p = 0.001), muscular endurance (p = 0.022), intrinsic motivation (p = 0.037), and body appreciation (p < 0.003) in comparison to the wait-list control group. All participants in the intervention group completed the intervention and compliance to the intervention was high (participants completed 18 ± 2 sessions). Conclusions. Although no change in PA was observed, HERizon resulted in improved physical fitness and psychosocial outcomes. These preliminary findings, alongside positive findings for feasibility and acceptability, highlight potential benefits from the home-based intervention, thus further investigation is warranted.

The feasibility of emotion-focused therapy for binge-eating disorder: a pilot randomised wait-list control trial

Background Research into psychotherapy for binge-eating disorder (BED) has focused mainly on cognitive behavioural therapies, but efficacy, failure to abstain, and dropout rates continue to be problematic. The experience of negative emotions is among the most accurate predictors for the occurrence of binge eating episodes in BED, suggesting benefits to exploring psychological treatments with a more specific focus on the role of emotion. The present study aimed to explore the feasibility of individual emotion-focused therapy (EFT) as a treatment for BED by examining the outcomes of a pilot randomised wait-list controlled trial. Methods Twenty-one participants were assessed using a variety of feasibility measures relating to recruitment, credibility and expectancy, therapy retention, objective binge episodes and days, and binge eating psychopathology outcomes. The treatment consisted of 12 weekly one-hour sessions of EFT for maladaptive emotions over 3 months. A mixed model approach was utilised with one between effect (group) using a one-way analysis of variance (ANOVA) to test the hypothesis that participants immediately receiving the EFT treatment would demonstrate a greater degree of improvement on outcomes relating to objective binge episodes and days, and binge eating psychopathology, compared to participants on the EFT wait-list; and one within effect (time) using a repeated-measures ANOVA to test the hypothesis that participation in the EFT intervention would result in significant improvements in outcome measures from pre to post-therapy and then maintained at follow-up. Results Recruitment, credibility and expectancy, therapy retention outcomes indicated EFT is a feasible treatment for BED. Further, participants receiving EFT demonstrated a greater degree of improvement in objective binge episodes and days, and binge eating psychopathology compared to EFT wait-list control group participants. When participants in the EFT wait-list control group then received treatment and outcomes data were combined with participants who initially received the treatment, EFT demonstrated significant improvement in objective binge episodes and days, and binge eating psychopathology for the entire sample. Conclusions These findings provide further preliminary evidence for the feasibility of individual EFT for BED and support more extensive randomised control trials to assess efficacy. Trial registration The study was retrospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000563965) on 14 May 2020.