Efficacy of a home-visiting intervention aimed at improving maternal sensitivity, child attachment, and behavioral outcomes for maltreated children: A randomized control trial

2011 ◽  
Vol 23 (1) ◽  
pp. 195-210 ◽  
Author(s):  
Ellen Moss ◽  
Karine Dubois-Comtois ◽  
Chantal Cyr ◽  
George M. Tarabulsy ◽  
Diane St-Laurent ◽  
...  
Keyword(s):  
Randomized Control Trial ◽  
Home Visiting ◽  
Intervention Group ◽  
Maternal Sensitivity ◽  
Control Group ◽  
Older Children ◽  
Short Term ◽  
Parental Sensitivity ◽  
Child Attachment ◽  
Randomized Control

AbstractThe efficacy of a short-term attachment-based intervention for changing risk outcomes for children of maltreating families was examined using a randomized control trial. Sixty-seven primary caregivers reported for maltreatment and their children (1–5 years) were randomly assigned to an intervention or control group. The intervention group received 8 weekly home visits directed at the caregiver–child dyad and focused on improving caregiver sensitivity. Intervention sessions included brief discussions of attachment–emotion regulation-related themes and video feedback of parent–child interaction. Comparison of pre- and posttest scores revealed significant improvements for the intervention group in parental sensitivity and child attachment security, and a reduction in child disorganization. Older children in the intervention group also showed lower levels of internalizing and externalizing problems following intervention. This is the first study to demonstrate the efficacy of short-term attachment-based intervention in enhancing parental sensitivity, improving child security, and reducing disorganization for children in the early childhood period.

scholarly journals Self-compassion to decrease performance anxiety in climbers: A randomized control trial

2021 ◽  
Vol 6 ◽  
pp. 004
Author(s):  
Philipp Röthlin ◽  
Romaine Leiggener
Keyword(s):  
Randomized Control Trial ◽  
Performance Anxiety ◽  
Intervention Group ◽  
Physical Symptoms ◽  
The Self ◽  
Waiting List ◽  
Control Group ◽  
Self Compassion ◽  
Randomized Control ◽  
Post Assessment

In climbing, anxiety may impair performance. Using an evolutionary approach, we hypothesized that athletes who treat themselves with self-compassion activate their contentment and soothing system and thus reduce their performance anxiety. A two-week randomized control trial was used to investigate the effect of self-compassion on somatic and cognitive anxiety. We compared two groups (intervention and waiting list) on two dates. Sixty climbers (Mage = 27.95, SDage = 8.57) completed the pre- and post-assessment. The intervention consisted of a psychoeducational leaflet and five self-compassionate writing tasks. In the posttest, the self-compassion intervention group showed increased self-compassion (F = 4.33, p = .04, ηp2 = 0.07) and decreased somatic performance anxiety (F = 6.24, p = .02, ηp2 = 0.10) compared to the waiting list control group. We found no changes in cognitive performance anxiety. The results suggest that self-compassion could be considered as a possible intervention to reduce physical symptoms of performance anxiety.

The Impact of a Foot-Toe Orthosis on Dynamic Balance: An Exploratory Randomized Control Trial

2020 ◽  
Vol 29 (7) ◽  
pp. 871-878
Author(s):  
Adam Kelly ◽  
Justin Stanek
Keyword(s):  
Randomized Control Trial ◽  
Daily Living ◽  
Dynamic Balance ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Balance Test ◽  
Randomized Control ◽  
And Control ◽  
The Impact

Context: The influence of custom and over-the-counter foot orthoses on dynamic balance has been investigated in the past. However, there has not been an exploration of the use of a foot-toe orthosis for improving balance. The ability of clinicians to influence balance could have important implications for injury prevention and rehabilitation. Objective: To determine the impact of a foot-toe orthosis on dynamic balance in healthy, young adults. Design: Randomized control trial. Setting: Athletic training laboratory. Participants: In total, 64 healthy, recreationally active participants aged 18–29 years were randomly allocated to one of the following groups: the foot-toe orthosis and laboratory-issued shoe group, the laboratory-issued shoe only (SO) group, or the control group. Interventions: Subjects in the intervention group wore the foot-toe orthosis and laboratory-issued shoe with activities of daily living for 4 weeks. Subjects in the SO intervention group wore the laboratory-issued shoe with activities of daily living for 4 weeks. Participants in the control group did not receive any intervention. Main Outcome Measures: The instrumented version of the Star Excursion Balance Test, known as the Lower Quarter Y-Balance Test, was used to quantify the dynamic balance at baseline and follow-up. Reaches were normalized for leg length. Results: There were statistically significant differences in postintervention scores on the Lower Quarter Y-Balance Test for both the dominant (P = .03, effect size = 0.84; 95% confidence interval, 0.25 to 1.43) and nondominant (P = .002, effect size = 0.74; 95% confidence interval, 0.15 to 1.32) legs when comparing dynamic balance scores of the foot-toe orthosis and laboratory-issued shoe group with the SO and control groups. No significant differences were observed when comparing dynamic balance between the SO and control groups. Conclusions: A 4-week intervention with a foot-toe orthosis and laboratory-issued shoe resulted in improved dynamic balance in a healthy young adult population. These findings suggest a novel intervention for increasing balance.

Testing the limits: Extending attachment-based intervention effects to infant cognitive outcome and parental stress

2017 ◽  
Vol 29 (2) ◽  
pp. 565-574 ◽  
Author(s):  
Karine Dubois-Comtois ◽  
Chantal Cyr ◽  
George M. Tarabulsy ◽  
Diane St-Laurent ◽  
Annie Bernier ◽  
...  
Keyword(s):  
Parental Stress ◽  
Subjective Experience ◽  
Intervention Group ◽  
Maternal Sensitivity ◽  
Cognitive Outcome ◽  
Psychomotor Development ◽  
Control Group ◽  
Parental Sensitivity ◽  
Self Reports ◽  
Group Report

AbstractUsing a sample of 41 infants and toddlers (21 interventions, 20 controls) who were neglected or at serious risk for neglect, this randomized clinical trial examined the efficacy of a parent–child attachment-based video-feedback intervention on parental sensitivity, parental stress, and child mental/psychomotor development. Results showed that following the 8-week intervention, scores for maternal sensitivity and child mental and psychomotor development were higher in the intervention group than in the control group. The intervention appears to have no effect on self-reports of stress. All parents report lower levels of stress postintervention; however, when defensive responding is not considered (i.e., extremely low score of parental stress), parents in the control group report somewhat lower scores, raising questions as to the significance of this finding. Considering the small nature of our sample, replication of the present results is needed. Nevertheless, the present findings contribute to the burgeoning literature suggesting that the early attachment relationship provides an important context that influences developmental outcome in different spheres and raises questions as to how such intervention strategies may or may not affect the subjective experience of parenting.

scholarly journals Lessons Learned from Replicating a Randomized Control Trial Evaluation of an App-Based Sexual Health Program

2021 ◽  
Vol 18 (6) ◽  
pp. 3305
Author(s):  
Jennifer Manlove ◽  
Brooke Whitfield ◽  
Jane Finocharo ◽  
Elizabeth Cook
Keyword(s):  
Randomized Control Trial ◽  
Unplanned Pregnancy ◽  
Intervention Group ◽  
Multiple Hypothesis Testing ◽  
Text Messages ◽  
Lessons Learned ◽  
Control Group ◽  
Probability Models ◽  
Randomized Control ◽  
Linear Probability

This study presents findings from a randomized control trial replication evaluation of Pulse, an app-based pregnancy prevention program implemented with Black and Latinx women aged 18–20, a population with high rates of unplanned pregnancy. We used social media advertisements to enroll 1013 women online across the U.S. and automatically randomized participants to either the Pulse reproductive health app or a general health control app, stratifying by age and race/Latinx ethnicity. Participants received reminder text messages to view the app as well as text messages with app-related content throughout the intervention. Linear probability models were conducted on the analytic sample of 871 participants who completed the six-week survey and 798 who completed the six-month survey and adjusted for permuted block randomization and multiple hypothesis testing. Compared to the control group, intervention group participants had higher contraceptive knowledge (p = 0.000), which replicates findings from an earlier evaluation. However, these impacts were not sustained at six-month follow-up (p = 0.162). We found no other significant program impacts. This contrasts with an earlier evaluation that found intervention participants were less likely to have had sex without a hormonal or long-acting reversible contraceptive (LARC) method and had greater self-confidence to use contraception consistently than the control group. Different demographic characteristics, lower app usage, and more negative attitudes about and usage of hormonal/LARC contraception in the current sample may help to explain fewer impacts than the earlier evaluation.

scholarly journals Efficacy of Smartphone-based Application on Stress Reduction: a Randomized Control Trial (Preprint)

2021 ◽  
Author(s):  
Hyunchan Hwang ◽  
Sun Mi Kim ◽  
Bo Netterstrøm ◽  
Doug Hyun Han
Keyword(s):  
Quality Of Life ◽  
Randomized Control Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Life Assessment ◽  
World Health ◽  
Control Group ◽  
World Health Organization Quality ◽  
Randomized Control

BACKGROUND Stress management within the workplace is important for a healthy mental and physical state. Due to technological advancements, individual-tailored therapy as well as online cognitive-behavioral therapy (CBT) is on the rise. OBJECTIVE This study analyzed the efficacy of a smartphone application based on third-wave CBT tailored to the individual. METHODS A randomized control trial was conducted on 126 participants who were divided into two groups. The intervention group used the smartphone application “BetterLife” for 10 weeks whilst the control group was put on a waiting list for the same duration. The Perceived Stress Scale-10 (PSS), Korean Utrecht Work Engagement Scale-9 (UWES), World Health Organization Quality of Life Assessment, abbreviated (WHOQOL), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI) were conducted at baseline and after 10 weeks in both groups. RESULTS Out of the 126 particiapnts, 11 dropped out during the trial. Two-way repeated measure analysis of covariance was conducted controlling for baseline BDI. There were greater improvements in PSS (F=24.33, P <.001, η2=0.17) and UWESK scores (F=8.32, P =.0046, η2=0.06) in the intervention group compared to the control group. WHOQOL scores exhibited statistically significance interactions in the intervention group in the overall quality of life (F=8.19, P =.0049, η2=0.06), and physical health (F= 8.87, P =.003, η2=0.07), psychological (F=13.32, P <.001, η2=0.10), social relationship (F= 19.43, P <.001, η2=0.14), and environmental domains (F= 10.14, P =.002, η2=0.08) but not in overall health (F= 1.68, P =.20). BDI showed a statistically significant improvement in the intervention group (F=7.17, P =.008, η2=0.06) as well as BAI (F=6.00, P =.02, η2=0.05), but this significance did not survive the Bonferroni’s correction (P <.005). CONCLUSIONS These results provide evidence that a smartphone application-based CBT is a viable option for reducing stress in the workplace. CLINICALTRIAL This trial has been registered in the Clinical Research Information Service (KCT0003231), a member of the WHO International Clinical Trials Registry Platform.

scholarly journals Injection of Lidocaine Alone versus Lidocaine plus Dexmedetomidine in Impacted Third Molar Extraction Surgery, a Double-Blind Randomized Control Trial for Postoperative Pain Evaluation

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Javad Alizargar ◽  
Milad Etemadi Sh ◽  
Nasser Kaviani ◽  
Shu-Fang Vivienne Wu ◽  
Keyvan Jafarzadeh ◽  
...  
Keyword(s):  
Pain Control ◽  
Randomized Control Trial ◽  
Intervention Group ◽  
Third Molar ◽  
Control Group ◽  
Double Blind ◽  
Impacted Third Molar ◽  
Third Molar Extraction ◽  
Randomized Control ◽  
Molar Extraction

Objectives. Administration of medications such as dexmedetomidine as a topical anesthetic has been suggested in the pain control in dentistry. This double-blind randomized control trial study evaluated postoperative pain and associated factors following impacted third molar extraction surgery. Lidocaine alone was taken as the control and lidocaine plus dexmedetomidine as the intervention. Materials and Methods. Forty patients undergoing mandibular third molar extraction entered the study and were randomly allocated to the control and interventional groups. 0.15 ml of dexmedetomidine was added to each lidocaine cartridge and the drug concentration was adjusted to 15 μg for the intervention group while only lidocaine was used in the control group. A visual analog scale was used to measure and record pain levels at the end of the surgery and 6, 12, and 24 hours after the surgery and number of painkillers taken by the patients after the surgery was also recorded. Results. Pain scores of the intervention group decreased significantly during the surgery and also 6, 12, and 24 hours after the surgery compared to the control group. The pain score was correlated significantly with our intervention during the surgery and also 6 and 12 hours after that (all P   value < 0 . 05 ). There was a nonsignificant reduction in the number of painkillers taken by the patients at 6, 12, and 24 hours after surgery (all P  value > 0 . 05 ). Conclusion. In patients undergoing molar surgery, administration of a combination of dexmedetomidine and lidocaine is beneficial for the pain control. Clinical Relevance. Compared to the injection of lidocaine alone, combination of dexmedetomidine and lidocaine can be used for a better pain control in molar surgeries.

scholarly journals The Effect of Aerobic Walking on Sleep Quality, Stress and Life Satisfaction: A Longitudinal Analysis a Randomized Control Trial

2020 ◽  
Author(s):  
Feifei Wang
Keyword(s):  
Life Satisfaction ◽  
Sleep Quality ◽  
Longitudinal Analysis ◽  
Repeated Measures ◽  
Randomized Control Trial ◽  
Statistical Significance ◽  
Intervention Group ◽  
Control Group ◽  
Significant Difference ◽  
Randomized Control

Abstract BackgroundThis study aimed to evaluate the longitudinal effects of a randomized control trial about a goal-setting aerobic walking intervention conducted among sedentary young adults.MethodsA 4-week daily aerobic walking (a. continually walking for at least 10 minutes; b. walk at least 60 steps per minute.) intervention was conducted to examine its effectiveness on sleep quality, stress and life satisfaction. Fifty-four participants aged 19–36 years old were assigned into two groups randomly (i.e. intervention group, control group). Sleep quality, stress and life satisfaction were assessed at baseline, post intervention and four weeks after the intervention by a battery of questionnaires. Omron HJ-112 pedometer and daily diary were used to facilitate the intervention process.ResultsThe comparison between intervention group and control group did not show significant difference in terms of sleep quality, stress and life satisfaction after intervention. Repeated measures ANOVA showed significant longitudinal effect with regard to stress (p = 0.03). Sleep quality was improved close to statistical significance (p = 0.06). Longitudinal analysis reported that the aerobic walking effect pertaining to life satisfaction rather than stress and sleep quality (p = 0.05).ConclusionsAerobic walking is an effective exercise for stress and sleep. Further studies are suggested to explore feasible intervention strategies that could bring long-term effectiveness to health.Trial registrationClinicalTrials.gov, NCT04427696. Registered 11June 2020- retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04427696?cntry=HU&city=Budapest&draw=2&rank=1

Feasibility Study Of a Randomized Control Trial To Evaluate An Internet-Based Self-Management Program For Adolescents With Hemophilia

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2921-2921 ◽  
Author(s):  
Vicky R Breakey ◽  
Danial M Ignas ◽  
Ashley Warias ◽  
Meghan White ◽  
Victor S. Blanchette ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Randomized Control Trial ◽  
Intervention Group ◽  
Management Program ◽  
Attrition Rate ◽  
Self Management ◽  
Control Group ◽  
Randomized Control ◽  
Lost To Follow Up

Abstract Introduction As adolescents with hemophilia approach adulthood, they must assume responsibility for their health and management of their disease. An online self-management program was developed to support adolescents during this transition. Aim To determine the feasibility of studying the online educational program using a non-blind, randomized control trial(RCT) design in terms of 1)Study accrual and attrition rates, 2) willingness to be randomized 3) compliance with the program and completion of the outcome measures, and 4) satisfaction with the program. Methods Adolescents, ages 13-18, were enrolled from three tertiary care centres in Canada in a pilot RCT (NCT01477437). After providing informed consent, adolescents were randomized to the intervention (8 week program with telephone coaching) or the control arm (no access, weekly telephone call as attention-strategy). Adolescents in both arms of the study were asked to complete pre- and post- outcome measures. Following completion of the program, quantitative analysis addressed the feasilibity measures and qualitative interviews were conducted to assess satisfaction. Results 29 teens participated (intervention group, n=16, control group, n=13).Participants in the intervention arm spent an average of 50 minutes on the website per week completed the 8 modules in an average of 14 weeks (SD= 4.9). Among those randomized to the intervention, 2 participants dropped out of the study and 2 were lost to follow-up, resulting in an attrition rate of 25% (4/16). The control arm had a higher attrition rate of 54% (7/13) with 5 participants being lost to follow-up and 2 participants dropping out. For participants who completed the program, 17/18 (94%) completed the post-study outcome measures. Despite the study not being powered to assess efficacy, teens on the intervention arm showed significant improvement in disease-specific knowledge (p=0.004), self-efficacy (p=0.007) and transition preparedness (p=0.046) over time. There was a statistically significant improvement in the knowledge measure in the intervention group when compared to the control group (p=0.01). Overall, the teens found the website to be informative, comprehensive and easy to use and were satisfied with the program. Conclusions This feasibility study suggests benefit to the program and indicates a full scale RCT to be a reasonable next step with minor adjustments to the protocol. The higher than expected attrition rate in the control group, suggests the need to improve the strategies for maintaining participant engagement using a more active attention control group (static educational materials) in the design of this web-based intervention prior to a larger study to assess efficacy. Disclosures: Breakey: Baxter Bioscience: Research Funding.

Immediate Effect of Mental Practice on Performance of a Neurodynamic Skill in Physiotherapy Students: A Randomized Control Trial.

2020 ◽  
Author(s):  
Kajal Uday Chheda ◽  
Isha Akulwar-Tajane
Keyword(s):  
Randomized Control Trial ◽  
Intervention Group ◽  
Mental Practice ◽  
Rank Test ◽  
Control Group ◽  
Physical Practice ◽  
Post Intervention ◽  
Significant Difference ◽  
Randomized Control ◽  
Physiotherapy Students

Abstract Background Mental Practice (MP), "the cognitive rehearsal of a task in the absence of overt physical movement," has been used successfully in teaching and rehearsing complex psychomotor tasks in several domains, including sports; music; and recently, in surgical skills acquisition. This study investigates the implementation of MP on performance of a neurodynamic skill in third year undergraduate Physiotherapy students. Method: It was a randomized control trial (single-blind) conducted in a Physiotherapy institute. A convenient sample of 40 III year undergraduate students who were novice for the topic were recruited. Some important preliminary steps involved development and validation of the tools used in the study viz. an audio script to guide mental imagery practice and an OSPE checklist to assess the outcome. The OSPE checklist was procedural specific for ULNT-1 and included stations for cognitive, psychomotor and affective domains. A neurodynamic skill (ULNT-1 Median nerve) was taught to all the students (n = 38, 2 drop outs) by a teacher as a didactic lecture followed by physical practice which was supervised and guided by the same teacher. After randomization, the intervention group (n = 19) received MP guided by a structured audio script as a single session for 20 minutes delivered to all the participants together in a group. The control group participants (n = 19) intended to serve as a basis of comparison and received no intervention. Pre- and post-intervention assessment was done by a set of examiners who were blinded to the intervention. Comparative analysis was done within the group using Wilcoxon sign rank test and between the groups using unpaired t test. Results MP group showed significant improvement in cognitive, psychomotor, affective domain and total score of OSPE post intervention whereas the control group did not show significant difference except for the total score. Between group comparison showed significant differences in all the domains and total score in favor of the MP group. Also, the extent of improvement (effect size calculated using Cohen’s d) was more in the mental practice group than in the control group. Conclusion MP as an adjunct to physical practice is a time-and cost-effective strategy to augment traditional training and enhance performance of a neurodynamic skill in Physiotherapy students. This preliminary evidence supported by robust scientific base and ease of integration should facilitate adoption of MP in Physiotherapy education. We recommend future studies to further explore the potential of this promising tool.

Effects of nutrition education and counseling intervention on maternal weight and obstetric outcomes among pregnant women of Gedeo Zone, Southern, Ethiopia: A cluster randomized control trial

2021 ◽  
pp. 026010602110567
Author(s):  
Gizaw Sisay ◽  
Adane Tesfaye
Keyword(s):  
Pregnant Women ◽  
Nutrition Education ◽  
Randomized Control Trial ◽  
Intervention Group ◽  
Southern Ethiopia ◽  
Control Group ◽  
Counseling Intervention ◽  
Cluster Randomized Control Trial ◽  
Randomized Control ◽  
Cluster Randomized

Background: Due to the scarcity of intervention trials, especially in Ethiopia, the effect of nutrition education and counseling intervention on pregnancy outcomes is not well studied. Aim: To assess the effect of nutrition education and counseling on the outcomes of pregnancy among pregnant mothers in public health care institutions of Gedeo Zone, Southern, Ethiopia. Methods: A cluster randomized control trial study design was undertaken. Simple random sampling followed by cluster sampling was used to reach eligible study participants. A total sample of 235 (115 intervention vs.120 control group) pregnant women who followed anti-natal care service in public health facilities of Gedeo Zone was included in the study. Independent t-test was used to analyze the group difference for continuous variable and chi-square test for categorical variables. The post-intervention values between the two groups were compared using analysis of covariance by adjusting to baseline variable. Results: After nutrition education, pregnant women in the control group had less weight gain than in the intervention. The proportion of LBW neonate was 17.8% in the intervention group and 38.2% in the control group ( P < 0.001). Multivariable logistic regression analysis showed that the risk of LBW in the control group was 2.43 more likely than in the intervention group (AOR = 2.43; 95% CI: (1.2, 4.92)). Conclusion: Nutrition education delivered to pregnant women during pregnancy could reduce maternal malnutrition and low birth weight. Recommendation: The intervention is easy to implement in the health facilities of Gedeo zone and would be implemented without delay to achieve the sustainable development goals.

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