Top PDF A randomized controlled trial of an intervention for infants’ behavioral sleep problems

A randomized controlled trial of an intervention for infants’ behavioral sleep problems

A randomized controlled trial of an intervention for infants’ behavioral sleep problems

Our intervention aimed to improve a BSP at an age when infants are developmentally capable of sustaining a long self-regulated sleep period for, on average, 10 h [20]. We sought to change families’ cognitions and be- haviors to promote infant self-soothing and targeted our intervention to both parents because both have affected infant sleep [21]. Parental cognitions are defined as be- liefs, expectations, and interpretations of children’s sleep behavior which are viewed as influencing parent-infant interactions and infant sleep patterns [22, 23]. Because public health nurses frequently encounter families ex- periencing infant BSP we trained them to deliver the sleep intervention. Nurses also delivered the safety con- trol sessions. The principal investigator created the ma- terials for the teaching sessions and phone calls. Total treatment duration was 3 weeks: one 2-h teaching ses- sion followed by bi-weekly telephone calls for 2 weeks. The nurses who delivered the teaching sessions called the parent leading the intervention/control twice a week for 2 weeks to reinforce concepts and provide support. The intervention and control groups were asked the same questions during the telephone calls: How were parents managing; what strategies were they using; what were the effects of their strategies on their infants and the parents; and what, if any, difficulties were they experiencing?
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A web based photo alteration intervention to promote sleep : randomized controlled trial

A web based photo alteration intervention to promote sleep : randomized controlled trial

In conclusion, we designed in this study a novel intervention emphasizing physical attractiveness as a function of sleep patterns. This was assessed through a rigorous randomized controlled trial design with the following [52]: (1) the key intervention personalized (following best practices in appearance-based interventions [28]), (2) sleep duration objectively assessed (via actigraphy), and (3) participants monitored for 5 weeks. Using this design, we found that the appearance-based intervention was more effective than standard education in promoting sleep hygiene, a precursor for healthier sleep. At the same time, these effects did not translate to sleep extension, suggesting the need to assess how appearance-based strategies can be paired with other interventions. In summary, while urging further replication and extension of this work, our preliminary results suggest that beauty—the driving force that launched a thousand ships—may have an adjunctive role in promoting sleep.
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Early Intervention Improves Cognitive Outcomes for Preterm Infants: Randomized Controlled Trial

Early Intervention Improves Cognitive Outcomes for Preterm Infants: Randomized Controlled Trial

METHODS: A randomized controlled trial of a modified version of the Mother-Infant Transaction Program was performed. Outcomes were assessed with the Bayley Scales of Infant Development II and the Wech- sler Preschool and Primary Scale of Intelligence-Revised at 3 and 5 years, respectively. McCarthy Scales of Children’s Abilities and the grooved pegboard test were used to test motor outcomes at 5 years. RESULTS: A total of 146 infants were assigned randomly (intervention group: 72 infants; control group: 74 infants). The mean BWs were 1396 ⫾ 429 g for the intervention group and 1381 ⫾ 436 g for the control group. After adjustment for maternal education, a nonsignifi- cant difference in Mental Developmental Index scores at 3 years of 4.5 points (95% confidence interval: ⫺ 0.3 to 9.3 points) in favor of the intervention group was found, whereas the intervention effect on full- scale IQ scores at 5 years was 6.4 points (95% confidence interval: 0.6 –12.2 points). Significantly more children in the intervention group had IQ scores of ⱖ 85 at 3 and 5 years. There were no differences between the groups with respect to motor outcomes.
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Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

Abstract: Increasing evidence suggests that positive affect plays an important role in adaptation to chronic illness, independent of levels of negative affects like depression. Positive affect may be especially beneficial for people in the midst of severe stress, such as the diagnosis of human immu- nodeficiency virus (HIV). As medical treatments for HIV have improved, the number of people living with HIV has increased, and prevention strategies tailored specifically to people living with HIV have become a priority. There is a need for effective, creative, client-centered interventions that can be easily disseminated to community treatment settings, but there are currently few established interventions for people who are newly diagnosed with HIV. We present the design and methods for a randomized trial in which we test the efficacy of one such skills-based intervention that targets positive affect as a novel mechanism of change. The proposed research builds on observational findings of the important unique functions of positive affect. We aim to determine whether a five-session theory- and evidence-based intervention designed to teach skills for increasing the frequency and intensity of daily positive affect does so, and whether this intervention has beneficial effects on subsequent psychological well-being, health behaviors, and physical health up to 15 months after diagnosis with HIV. This is a randomized controlled trial in a sample of adults recruited within 12 weeks of testing positive for HIV. The control group is attention-matched, and follow up assessments will be conducted immediately post intervention (approximately 5 months post diagnosis) and at 10 and 15 months post diagnosis. This study is an important next step in research concerning the adaptive functions of positive affect for people coping with HIV or other health-related life stress.
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Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial

Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial

This randomized controlled trial of behavioral interventions for infant sleep problems found meaningful effects for both graduated extinction and bedtime fading. Compared with the control group, large reductions in nocturnal wakefulness resulted from each treatment. Despite assertions that extinction-based methods may result in elevated cortisol, emotional and behavioral problems, and insecure parent-infant attachment, our data did not support this hypothesis. Coupled with the findings from Price and colleagues, 41

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Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial

Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial

One strength of this study is our comprehensive meas- urement of costs associated with the care of pregnant women, including intervention costs, costs during the prenatal period, and maternal and newborn costs up to 3 months postpartum, as well as both hospital facility costs and physician costs. In contrast, prior economic evaluations of substance use programs for pregnant women were often limited to drug treatment costs or se- lected care components (e.g., neonatal intensive care unit costs) [22–25]. Few have assessed the impact of intervention on overall maternal and newborn costs. In addition, by conducting an economic evaluation in the context of a randomized trial, we were able to rigorously assess the financial consequences of the intervention as potential impact of unobserved con- founding factors was minimized. In contrast, previous studies evaluating the economic impact of substance use treatment programs in pregnancy were largely based on non-randomized designs limiting their abil- ity to draw causal inferences [22–27].
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A pragmatic randomized controlled trial of a guided self help intervention versus a waiting list control in a routine primary care mental health service

A pragmatic randomized controlled trial of a guided self help intervention versus a waiting list control in a routine primary care mental health service

to Psychological Therapies (IAPT) services, which has received significant investment (Department of Health, 2007). Low intensity interventions are provided by workers such as primary care graduate mental health workers (PCGMHWs) and Psychological Wellbeing Practitioners (PWPs). Both these roles have been developed in the UK to provide CBT based interventions such as guided self-help for patients with mild to moderate common mental health problems. They are not trained as therapists but receive training and ongoing clinical supervision to provide low intensity interventions. They therefore differ from paraprofessionals who may not have received any
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Telephone delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial

Telephone delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial

The primary aim of this on-going randomized trial is to assess the efficacy of a culturally and linguistically tai- lored telephone-delivered intervention to increase adher- ence to physician-recommended assessment and treatment of sleep apnea. The secondary aims are to: 1) evaluate the maintenance of intervention effects on adherence at 6 months post-randomization; and 2) assess treatment ef- fects on indices of the metabolic syndrome (waist circum- ference, blood pressure (BP), lipid levels and fasting plasma glucose (FPG) or hemoglobin (HbA1c) for those who have a DM diagnosis). There are four main hypoth- eses for this study: 1) participants will show greater adher- ence to physician-recommended polysomnographic sleep apnea evaluation during follow-up assessment; 2) partici- pants will show greater adherence to CPAP treatment during follow-up assessment; 3) effects of the inter- vention on adherence rates will be maintained 6 months after discontinuing active interventions, and treatments will improve indexes of the metabolic syndrome; and 4) participants’ knowledge about sleep, self-efficacy, readiness, and trust/rapport with the health educator (HE) will mediate intervention effects on study outcomes. The study is registered in clinicaltrials.gov.
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A randomized controlled trial of a mindfulness-based intervention program for people with schizophrenia: 6-month follow-up

A randomized controlled trial of a mindfulness-based intervention program for people with schizophrenia: 6-month follow-up

The manuals of both the MPGP and CPGP were vali- dated by an expert panel (two psychiatrists, four specialists in psychiatric rehabilitation from allied health professions such as mental health nurse, occupational therapist, and clinical psychologist, and two volunteer peer mentors or ex-patients). The panel assessed the clarity and appropri- ateness on the topics, case examples, and practices of each manual independently. Most of the topics in these manuals were rated “very satisfactory” or “excellent” on both the clarity (90%–98%) and appropriateness (91%–96%). Only a few items were reworded on their ways/styles of expres- sion, format, and/or terminology. Intervention fidelity was assessed with a checklist to assess adherence to the topics and instructions, as recommended by the National Institute of Health Behaviour Change Consortium. 37 The research team
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A Brief Sleep Intervention Improves Outcomes in the School Entry Year: A Randomized Controlled Trial

A Brief Sleep Intervention Improves Outcomes in the School Entry Year: A Randomized Controlled Trial

Intervention families received a pri- vate consultation at their child’s school followed by a telephone-based consultation a fortnight later, with a second private consultation after an additional week if requested by the parent. Three research assistants (1 registered psychologist, 1 registered nurse, and 1 trainee psychologist) were trained by Drs Quach and Hiscock for three 2-hour sessions to conduct the intervention. Figure 1 provides de- tails of the intervention program, which involved eliciting a description of the parent’s perception of the child’s sleep problem and the parent’s goals for the child’s sleep. Flexible yet standardized behavioral strategies tai- lored to the child’s sleep problem were presented to parents. In addition to be- ing presented with information about age-appropriate normal sleep cycles and given the opportunity to discuss this information, parents were taught about good sleep hygiene practices (eg, providing a good sleep environ- ment, limiting caffeine consumption after school), the importance of con- sistent bedtime routines on all nights of the week, and behavioral strategies specific to the child’ sleep problem, such as bedtime fading with set morn- ing wake times for delayed sleep phase, graduated extinction for limit- setting disorders, and relaxation strat- egies for anxiety leading to insomnia. Behavioral strategies were based on recommendations from the American Academy of Sleep Medicine and review of current research literature. 29 Par-
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Weight loss intervention for individuals with high internal disinhibition: design of the Acceptance Based Behavioral Intervention (ABBI) randomized controlled trial

Weight loss intervention for individuals with high internal disinhibition: design of the Acceptance Based Behavioral Intervention (ABBI) randomized controlled trial

Forman and colleagues conducted a 12-week open trial, which served as the first test of a combined stand- ard behavioral + ACT intervention (Forman et al. 2009). Results showed 4.5 % weight loss post-treatment and 6.6 % at 6-month follow-up for intent-to-treat, and 6.6 % and 9.6 % respectively for completers (64 %). Based on these positive outcomes, the authors then conducted a randomized trial comparing the combined treatment (referred to as acceptance-based behavioral treatment, or ABT) to SBT (Forman et al. 2014). Both groups pro- duced significant weight loss and the overall weight losses did not differ between groups. However a post- hoc analysis suggested that when administered by ex- perts, weight loss was significantly higher in ABT than SBT at post-treatment (13.2 % v. 7.5 %) and 6-month follow-up (10.9 % vs. 4.8 %). In addition, the ABT ap- proach was found to be particularly effective in partici- pants who reported high levels of emotional eating and disinhibition at post treatment (12.6 % vs 8.2 % and 12.3 % vs. 10.4 % respectively) and 6-month follow-up (10.5 % vs 6.0 %; 8.3 % vs. 6.3 %).
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Early Intervention Improves Behavioral Outcomes for Preterm Infants: Randomized Controlled Trial

Early Intervention Improves Behavioral Outcomes for Preterm Infants: Randomized Controlled Trial

Project “ Early Intervention 2000 ” was designed to test the ef fi cacy of a modi- fi ed version of the MITP on long-term infant development. We hypothesized that this sensitizing EI program would promote better parenting and thereby optimize long-term child cognitive and behavioral development. We found no signi fi cant effects on behavioral out- comes at corrected age of 2 years, but children in the intervention group scored consistently lower on all symp- tom scales compared with controls. 23

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A parenting intervention for childhood behavioral problems: A randomized controlled trial in disadvantaged community based settings

A parenting intervention for childhood behavioral problems: A randomized controlled trial in disadvantaged community based settings

Families were recruited to the study using existing service systems including public health service waiting lists, local schools, community-based agencies and self-referral. Participants were eligible if the primary caregiver rated their child (aged 32–88 months) above the clinical cut-off on either the Intensity subscale (Intensity score ≥ 127) or the Problem subscale (Problem score ≥11) of the Eyberg Child Behavior Inventory (ECBI; Eyberg & Pincus, 1999). This cut-off has been used in similar research and is considered to indicate potentially significant psychopathology (Hutchings et al., 2007a). Parents also had to be willing and able to attend the program. In total, 149 families were eligible and agreed to participate in the research. At follow-up, 137 parents were retained in the trial (Figure 1).
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A genotype specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial

A genotype specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial

A cognitive behavioral intervention is effective in preventing PTSD symptoms after intensive care therapy Although counterintuitive, increased analgesia and sed- ation of critically ill patients intended to prevent traumatic experiences during ICU treatment has not been successful in avoiding PTSD but has shown the opposite effect [13]. By contrast, a number of early interventions based on cog- nitive behavioral intervention (CBI) have been effective in improving the neuroemotional outcome of critical illness. A study in patients having CS showed that preoperative CBI (for example, explaining cardiac myths and miscon- ceptions, detailing what to expect during the hospital stay and subsequent recovery period) improved physical func- tion and depression after surgery [14]. Early psychological intervention in patients during ICU treatment by trained psychologists resulted in a lower incidence of PTSD symp- toms and a lower use of psychotropic medication during follow-up [15]. The use of an intensive care diary, which has comparable effects to CBI by changing how patients think about their illness as they reread the story and build an autobiographical memory, has also been effective in re- ducing PTSD symptoms in patients after ICU therapy [16]. A detailed explanation of the forthcoming events
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Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

to fall farther behind in adaptive be- havior. Given the importance of adaptive behavior for everyday func- tioning at home and school, the fact that the ESDM group did not continue to fall farther behind is likely to af- fect ability to function in less- restrictive environments. This dem- onstrates that the ESDM intervention accelerates overall development and is generalizing to everyday life. Whereas 71% of the children in the group that received community- based intervention retained their di- agnosis of autistic disorder over the 2-year period, only 56% of children in the ESDM group did so. The diagnosis of 7 children (30%) in the ESDM group changed from autistic dis- order to PDD NOS, whereas this only occurred for 1 child (5%) in the community-intervention group. These diagnostic assessments were conducted by experienced clinicians who were naive with respect to intervention-group status. However, this change in diagnostic severity was not reflected in significant dif- ferences in the ADOS severity scores. This lack of correspondence be- tween measures is difficult to inter- pret, because the child’s perfor- mance in the ADOS contributes to clinical diagnosis. However, other behaviors, including parental report, also contribute to overall clinical diagnosis. The repetitive-behavior scores also did not change over time in either group.
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Behavioral intervention for sleep problems in childhood: a Brazilian randomized controlled trial

Behavioral intervention for sleep problems in childhood: a Brazilian randomized controlled trial

Adult Self-Report (ASR) (Achenbach & Rescorla, 2003) ASR is a self-administered questionnaire for individuals from 18 to 59 years of age, comprising 126 items in total. This instrument evaluates aspects of the participants’ adap- tive and psychopathological functioning. Each item has three response options that vary from one “not true” to two “very true or often true.” This instrument was translated into Brazilian Portuguese by (Rocha et al.: Validation evidences for the Brazilian versions of Adult Self Report (ASR) and Adult Behavior Checklist (ABCL), unpublished) and was shown to be reliable, having an internal consistency (Cronbach’s alpha) with a value above 0.6. In the present study, the alpha values for the different syn- dromes ranged from 0.6 to 0.8. For this study, the mother’s behavioral problems total score was used only as a covariate in the model for control, not as a measure of interest.
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Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial

Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial

our study, we found no association between total time spent on the intervention and infant motor performance. Although the total number of sessions was less than intended, a significant difference was found in change in motor performance between the intervention and control groups between 34 and 37 weeks’ PMA. We speculate that this finding might be due to the fact that the infants participated actively during the intervention, as was the criteria for doing the intervention. In addition, the fact that the parents learned to read their infant’s signals could have resulted in transfer to other situations, and thereby led to increased time spent on the intervention other than reported in the logs. Intervention once a day seemed to be feasible for most parents and could be used as part of ordinary clinical practice in similar populations of infants born preterm. Principles to reduce stress (Newborn Individualized Developmental Care and Assessment
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mHealth technologies in the management of obesity: a narrative review

mHealth technologies in the management of obesity: a narrative review

the utility of using a Smartphone to deliver intervention components in a multicomponent program. The interven- tion consisted of Smartphone self-monitoring, automated and human feedback, and education and skills training via video, as well as weekly in-person weigh-ins and paper handouts, which were found to produce an average of 9% loss of initial body weight (8.4 kg) at 12 weeks and 11% (10.9 kg) at 24 weeks. These findings indicate that Smart- phones could be mediums for enhancing the delivery of personalized behavioral weight loss treatments, thereby reducing cost and resources required for face-to-face treat- ments. A randomized controlled trial of a multicomponent intervention to prevent weight gain in younger adults that
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Unexpected consequences: women’s experiences of a self hypnosis intervention to help with pain relief during labour

Unexpected consequences: women’s experiences of a self hypnosis intervention to help with pain relief during labour

Interviews were conducted alongside the main SHIP Trial, a randomized controlled trial investigating the ef- fect of an antenatal self-hypnosis training programme on rates of epidural use amongst laboring women. The 678 participants in the trial were randomly assigned to the intervention group (self-hypnosis training; n = 343) or the usual care group (n = 335). Both groups received the standard package of antenatal education delivered by the NHS Trust and, in addition, intervention participants re- ceived group tuition in the use of self-hypnosis for anx- iety and pain relief during labour. The tuition consisted of two 1.5 h training sessions at around 32 weeks and 35 weeks pregnancy, supported by a take-home, practice CD that participants were encouraged to listen to on a daily basis from the first training session until the birth of their baby. All of the women (in both groups) were aged 18 or more and were experiencing their first preg- nancy. Birth companions/partners were recruited along- side the women in both groups and, where possible, attended the intervention or educational training ses- sions in a supportive role. Clinical data relating to the outcomes of the trial were collected at the Trust site and additional data were collected from the trial participants via questionnaires distributed at four time points: base- line (27 weeks gestation), 36 weeks (after the interven- tion) and 2 and 6 weeks post-natal (Downe et al. [13]).
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Improving Self-Regulation for Obesity Prevention in Head Start: A Randomized Controlled Trial

Improving Self-Regulation for Obesity Prevention in Head Start: A Randomized Controlled Trial

conducted in each of 4 academic years from 2011 to 2015. Participants (697 children; 49% boys; mean age: 4.1 ± 0.5 years; 48% white, 30% African American, 12% Hispanic) were randomly assigned by classroom to 1 of 3 intervention arms: (1) HS + Preschool Obesity Prevention Series (POPS) + Incredible Years Series (IYS) (HS enhanced by the POPS [program targeting evidence-based obesity-prevention behaviors] and the IYS [program to improve children’s self-regulation]), (2) HS+POPS, or (3) HS. Primary outcomes were changes in prevalence of obesity, overweight/obesity, BMI z score, and teacher-reported child emotional and behavioral self-regulation; secondary outcomes were dietary intake, outdoor play, screen time, and parent nutrition knowledge and nutrition self-efficacy.
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