Cooperative Parent-Mediated Therapy in Children with Fragile X Syndrome and Williams Beuren Syndrome: A Pilot RCT Study of a Transdiagnostic Intervention-Preliminary Data

Children with fragile X syndrome and William Beuren syndrome share several socio-communicative deficits. In both populations, around 30/35% of individuals meets criteria for autism spectrum disorder on gold standard instruments. Notwithstanding, few studies have explored feasibility and validity of therapy for socio-communicative deficits in individuals with these genetic conditions. In this study, we present preliminary data on a pilot RCT aimed to verify the effectiveness of cooperative parent-mediated therapy for socio-communicative deficits in a transdiagnostic perspective in a small sample of 12 participants. Our preliminary data showed that the experimental group had significant improvement in one socio-communicative skill (responsivity) and in clinical global impression, while the control group in an adaptive measure of socialization and word production. Implications of these results are then discussed.

Brief Video-Delivered Interventions to Reduce Anxiety in Older Veterans: A Pilot RCT

Older Veterans with anxiety disorders encounter barriers to receiving mental health services that may be overcome by using brief technology-delivered interventions. To address this, we conducted a pilot randomized controlled trial (RCT) comparing the effects of a guided self-management intervention called BREATHE, a 4-week video-delivered (DVD/internet) intervention and a psychoeducation control (Healthy Living; HL) on anxiety symptom severity. Older Veterans with anxiety disorders (N = 48; 87.5% men; Mean age = 71.77 ± 6.2 years) were randomized to BREATHE or HL. Regarding intervention delivery modality, 67% used DVDs, 23% used the internet, 4% used both to access their assigned intervention. Both groups experienced significant declines in affective anxiety from baseline to 8 weeks followed by an increase in symptoms (i.e., quadratic pattern). HL had significant declines in somatic anxiety, whereas BREATHE did not experience such declines. The longitudinal effects and Veteran satisfaction will be further described in the presentation.

Augmentative and alternative communication intervention for in-patient individuals with post-stroke aphasia: study protocol of a parallel-group, pragmatic randomized controlled trial

Background People with post-stroke aphasia commonly receive speech-language therapy (SLT) when they are admitted to hospitals. Commonly, these patients reported communication difficulties in in-patient settings. Augmentative and alternative communication (AAC) has been reported as an effective treatment approach to improve communication effectiveness, language performance, decreasing depression, and improving quality of life for this population. However, little evidence has demonstrated the use of AAC intervention (AACT) in early recovery from people with post-stroke aphasia in in-patient rehabilitation settings for improving these patients’ communication effectiveness. The pilot randomized controlled trial (RCT) will explore the effectiveness and feasibility of including AACT in regular SLT for in-patient people with post-stroke aphasia. Method This pilot RCT is a single-blind, randomized controlled trial with two parallel groups. Both groups receive a 1-h treatment session, including either both AACT and SLT or SLT only for ten consecutive days. We aim to include 22 in-patient participants with post-stroke aphasia in each group. Participants will be assessed at pre- and post-intervention and 2 weeks after intervention. The primary outcomes are the ability of communication measured by the communication of basic needs subtest in the Functional Assessment of Communication Skills for Adult (FACS) and the overall language performance measured by the Chinese Standard Aphasia Battery (ABC). The secondary outcomes include a 10-min conversation, the 10-item Hospital version of the Stroke Aphasic Depression Questionnaire (SADQH-10), the Stroke-Specific Quality of Life Scale (SS-QOL), and a patient and caregiver satisfaction questionnaire. Discussion This pilot RCT will contribute to new scientific evidence to the field of aphasia rehabilitation in early recovery during the in-patient period. The paper describes the trial, which will explore the effect of combining AACT and SLT and SLT only, our choice of primary and secondary outcome measures, and proposed analyses. The study results will provide information for implementing AACT in the regular in-patient SLT of future RCTs. Trial registration Chinese Clinical Trial Registry database (ChiCTR) ChiCTR2000028870. Registered on 5 January 2020

Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy

BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

P012 Maternal and infant stress during a bedtime separation: a pilot RCT

Background Behavioural sleep interventions to improve infant sleep disturbance commonly include extinction where an unwanted behaviour (night time crying) is periodically ignored. There have been conflicting findings regarding the impact of extinction methods on infant stress levels as measured with cortisol and as perceived by mothers and only one that measured cortisol at the time of the separation. This study aimed to compare a responsive method to extinction (controlled crying) and a control group evaluating subjective and objective stress for mother/infant dyads at the time of bedtime separation. Methods Mother/infant dyads were randomly allocated to behavioural sleep interventions (Responsive - n= 7, Controlled Crying - n=6 or Controls - n=4). Cortisol (two oral swabs on two nights at T2), maternal self-reported stress (Subjective Units of Distress - SUDS), and perceived infant distress (PIS) were compared over eight weeks. Correlations tested relationships between PIS, SUDS and infant cortisol levels. Mixed models analysis were used for cortisol analyses. Results There were no significant differences in cortisol levels between groups across time points but significant inter and intra-individual variability. Maternal stress was positively correlated with infant cortisol and PIS (p<0.05) and mothers in the Responsive group were significantly less stressed (p=0.02). Conclusion In this small sample, infant cortisol during bedtime separation was variable, elevated in all sleep interventions and not significantly different. Mothers were less stressed in the Responsive group. Findings indicate responsive methods are comparable to extinction and less stressful for mothers offering a possible gentler choice at bedtime separation.