Clinical Research Directory

Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder

This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum disorder (ASD). Children with ASD in the intervention group will receive a structured program in which parents attend an in-person training session (approximately 2.5 hours) at the hospital, where parents are taught to administer a series of researcher-designed cooperative game paradigms at home. Parents then deliver the intervention daily for at least 30 minutes per session over a period of six months. Monthly online video reviews by a clinician provide parents with individualized feedback and guidance to ensure program fidelity and quality. Children with ASD in the comparison group will continue to receive usual care and will not receive the program during the study period. Social cognitive outcomes - including emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication - will be assessed at baseline and at 12-month follow-up using behavioral experimental tasks and eye-tracking paradigms. This study aims to provide evidence for the efficacy of a scalable, family-implemented social cognition intervention for young children with ASD.

Feasibility and Outcomes of Therapist-led Online Cancer Bereavement Groups

Background: The loss of loved one to cancer brings unique difficulties that impact on the bereavement experience. Mixed support exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness of online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little empirical evidence for therapist led groups, or for those bereaved by cancer. Objectives: This paper describes the protocol for a pilot feasibility trial evaluating the feasibility, potential effectiveness and acceptability of delivering online therapy groups for those bereaved by cancer. Methods and analysis: It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a future definitive RCT. Participants: A total of 100 adults who have lost a loved one to cancer will be randomised to receive the intervention immediately or after a delay three months later. Interventions: An eight-session online therapeutic group intervention led over 12 weeks based on models of cognitive behavioural therapy, compassion focused therapy and coping with bereavement. Primary outcome measures: Cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Acceptability of the intervention will also be measured including what participants found most helpful or unhelpful about the groups and any adverse outcomes. Data collection will occur at baseline, intervention completion and at follow up, 3 months after intervention completion. Results: The feasibility of trial procedures and the effect of the intervention on the outcomes will be tested,. Conclusions: At intervention completion, it is hoped that participants will show reductions across all outcomes measures with improvements remaining at follow up, compared to the waitlist-control group, warranting the need for a full-scale RCT to establish efficacy. Trial registration (intended registry): Protocol version: 1 (No amendments currently), Issued:

Online Socio-emotional Dyad Training for School Teachers' Well-being and Social Skills

The Edu:Social School Study 2 is a randomized controlled trial designed to evaluate the effects of an 8-week socio-emotional, partner-based empathy-compassion Dyad training program (EmCo) compared with a mindfulness-based training (MBT) and a waitlist control group (WLC) in school teachers. The primary objective is to assess the efficacy of the adapted 8-week online EmCo Dyad training program across multiple domains of teacher functioning. Seven domains capture individual-level outcomes: (1) mental health, (2) resilience, (3) attention and cognitive processes, (4) social emotions, (5) stress coping and emotion regulation, (6) listening skills, and (7) voice-based emotional expression (DYVA). Two additional domains assess broader contextual outcomes: (8) classroom teaching and (9) organizational/school level outcomes, reflecting how individual-level changes may translate into perceived changes in the teaching and school context. To this end, participants will be randomized into one of three groups: (1) an 8-week EmCo Dyad intervention (EmCo), (2) an 8-week mindfulness-based training program (MBT), or (3) a waitlist control group (WLC) that will receive the EmCo intervention after completion of the initial post-test. Both interventions are delivered online via a dedicated study application to ensure scalability and accessibility. A second aim is to validate the Egocentric Social Network Analysis Paradigm (e-SNAP) as a measure of teachers' perceived social interactions and network structures. This study represents the first randomized controlled trial in teachers to examine whether changes in internal psychological processes are associated with perceived changes in the perception of the quality of interaction between school teachers and their students in the classroom as well as between school teachers and their colleagues in school. A third aim is to introduce and validate objective measures of emotional processing based on AI-based voice analysis in educational field research. Specifically, the study will evaluate two tasks using different parameters of AI-based emotional voice analysis: (a) the Teacher Voice Assessment (TEAVA), in which teachers' voices are recorded during a teaching-related task, and (b) the Dyad Voice Assessment (DYVA), conducted during the daily partner-based Dyad practice. In both tasks, non-semantic vocal features (e.g., pitch, loudness, speaking rate, intonation) and vocal emotional expressions (e.g., arousal, valence, dominance, and basic emotional categories) will be analyzed using audEERING devAIce software. No speech content will be transcribed or analyzed. A final aim is to investigate the cognitive and affective mechanisms underlying intervention-related changes. Based on prior research, the EmCo Dyad training is expected to enhance care- and affiliation-related motivational systems associated with positive affect, social emotions and connectedness, and prosocial behavior, while reducing loneliness, social stress, and other forms of psychological vulnerability. In contrast, mindfulness-based training is expected to primarily strengthen attention- and thought-related processes, including present-moment awareness, calming the mind and executive attentional control. These mechanisms are expected to contribute to improvements in mental health and overall well-being across both intervention groups.

Home-based Self-sampling for Cervical Cancer Prevention Education Intervention in Ghana

The investigators propose to develop and/or adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana. These "implementation support strategies (ISS)" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice. The ultimate goal is to facilitate health system adoption and sustainment.

The Effect of Cognitive Behavioral Therapy

The aim of this study is to investigate the effect of hand hygiene training applied using cognitive behavioural therapy techniques on healthcare workers' attitudes and beliefs regarding nosocomial infections. Another aim is to increase the effectiveness of hand hygiene training and to instil correct hand hygiene behaviour by utilising cognitive behavioural therapy to raise awareness of nosocomial infections among healthcare workers. This is a single-centre, double-blind, randomised, controlled trial with a single parallel group. The hypothesis is that hand hygiene training using cognitive behavioural therapy techniques will influence healthcare workers' attitudes and beliefs regarding nosocomial infections.