pilot randomized control trial
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2022 ◽  
pp. 0192513X2110648
Author(s):  
Valen R. Diaz ◽  
Tashuna Albritton ◽  
Marina Katague ◽  
Victoria Dancy ◽  
Jean M. Breny ◽  
...  

Relationship strain or dissolution between new parents can affect the co-parenting relationship and parenting engagement. The purpose of this study was to evaluate the effect of a relationship-strengthening intervention on parenting behaviors among adolescent couples. Data from a pilot randomized control trial conducted with predominantly Black and Latino couples were analyzed using repeated measures analysis of variance. Observed intervention * time effects and intervention * time * gender effects were not statistically significant, but had small to moderate effect sizes. Intervention couples demonstrated increased parenting sense of competence compared to control couples. Gender differences in intervention effects were observed for both parenting experiences and parenting engagement. Given the pilot nature of the study, these findings provide preliminary evidence of the effectiveness of this couple-based intervention for improving parenting outcomes. Future research should assess the intervention in a larger sample and leverage technology-based approaches as methods for content delivery.


2021 ◽  
Vol 12 ◽  
Author(s):  
Claire B. Klein ◽  
Deanna M. Swain ◽  
Bethany Vibert ◽  
Elysha Clark-Whitney ◽  
Amy R. Lemelman ◽  
...  

Video feedback (VF) is an intervention delivery technique that complements naturalistic developmental behavioral interventions (NDBI) and parent-mediated interventions (PMI) by using caregiver-child interaction videos reviewed with a clinician to facilitate behavioral change in caregivers. Although VF has been implemented in PMI with young children with ASD, examinations of feasibility and acceptability, as well as the potential effectiveness of VF in community settings, have been limited. In this pilot randomized control trial (NCT03397719; https://clinicaltrials.gov/ct2/show/NCT03397719), families were randomized into a state-funded Early Intervention (EI) NDBI program or the NDBI program augmented with VF. Results demonstrated high levels of implementation and acceptability of VF augmenting the community-based EI program in caregivers and clinicians. Both groups showed significant improvements after 6 months in social communication symptoms and some areas of developmental and adaptive skills.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03397719, identifier: NCT03397719.


2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi227-vi227
Author(s):  
Carolyn Lai ◽  
Alireza Mansouri ◽  
Damon Scales ◽  
James Perry ◽  
Arjun Sahgal ◽  
...  

Abstract High grade gliomas are the most common primary malignant brain tumor in adults having a median survival of only 13–16 months. This is despite the current standard of maximal safe surgical resection followed by fractionated radiotherapy and chemotherapy. Extending the tumor resection limit beyond the GAD-enhancing margin (i.e. supra-marginal resection) could in principle provide an added survival benefit as it has been shown that >80% of post-operative tumor recurrence is within a 2cm region surrounding the original GAD-enhancing margin. However, this must be weighed against the risk of potential damage to functional brain tissue. In this phase II pilot randomized control trial (RCT), we aim to assess the feasibility of “supra-marginal” resection extending 1cm beyond the enhancing tumor in adults with radiographic evidence of GAD-enhancing intra-axial tumour consistent with high grade glioma in a safe anatomical location and a Karnofsky Performance Score > 60. With six academic centres participating, we aim to enroll 72 patients over two years. Currently, four patients have already been enrolled in the first four months. Primary outcomes include evaluating the feasibility of performing a large-scale trial with regards to recruitment, allocation and outcome documentation as well as safety data. Secondary outcomes include determining if there is an increased survival benefit with supra-marginal resection and impact on quality of life. Our pilot RCT will test the feasibility of comparing standard gross total resection of GAD-enhancing tumour and supra-marginal resection to prepare for a larger definitive multicentre RCT.


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