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The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual.

ABSTRACT: Problems in infant mental health such as the ability to experience, regulate, and express emotional states is expressed in behavioral problems like excessive crying, feeding, and sleeping problems. Parenting programs are popular but their effectiveness on infant mental health remains uncertain. Possibly, because recent studies have focused only on parental and parent-child measures while they miss to assess infant behavioral measures. The goal of this pilot study is to fill in this gap by assessing infantile behavioral measures. We investigated the acceptance and first indicators of efficacy of the universal group parenting training Baby Triple P (BTP) compared to a care as usual (CAU) control condition focusing on early behavioral problems. In all, 49 couples were randomly allocated to receive either eight BTP sessions before birth and per telephone after birth or to take part in CAU. Infant behavior was assessed with a diary and a structured diagnostic interview. Parental self-report measures of partnership quality and parental competence were assessed before birth, 10 weeks after birth and at 6-month follow-up. Since the parent training was conducted before the birth of the child, the child's mental health could not be assessed before the parent training. Thus, for this variable no within measurement (pre-post) could be carried out and intention-to-treat analysis was not possible. However, a between group analysis comparing BTP against CAU took place to assess effectiveness of BTP on children's mental health. Mothers and fathers rated the program as feasible and relevant. Results indicate significant group differences in crying behavior 6 months after birth to the benefit of the intervention group. No beneficial outcomes were found for feeding and sleeping problems in infants or partnership quality, parental sense of competence in parents. Due to an unrepresentative high level of education of the participating parents and the small sample size, these findings can be considered preliminary. Nevertheless, these results allow to further investigate the effectivity of BTP in large-scale clinical trials. Behavioral diaries or diagnostic interviews for early mental health problems should be routinely implemented in randomized controlled trials (RCTs) in order not to miss possible behavioral changes in infants. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02313493.

SUBMITTER: Popp L

PROVIDER: S-EPMC6828945 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual.

Popp Lukka L Fuths Sabrina S Schneider Silvia S

Frontiers in psychology 20191029

Problems in infant mental health such as the ability to experience, regulate, and express emotional states is expressed in behavioral problems like excessive crying, feeding, and sleeping problems. Parenting programs are popular but their effectiveness on infant mental health remains uncertain. Possibly, because recent studies have focused only on parental and parent-child measures while they miss to assess infant behavioral measures. The goal of this pilot study is to fill in this gap by assess ...[more]

PMID: 31736826

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Project description:BACKGROUND:Infant mental health is a significant public health issue as early adversity and exposure to early childhood stress are significant risk factors that may have detrimental long-term developmental consequences for the affected children. Negative outcomes are seen on a range of areas such as physical and mental health, educational and labor market success, social network and establishing of family. Secure attachment is associated with optimal outcomes in all developmental domains in childhood, and both insecure and disorganized attachment are associated with a range of later problems and psychopathologies. In disadvantaged populations insecure and disorganized attachment are common, which points to the need of identifying early risk and effective methods of addressing such problems. This protocol describes an experimental evaluation of an indicated group-based parental educational program, Circle of Security-Parenting (COS-P), currently being conducted in Denmark. METHODS/DESIGN:In a parallel randomized controlled trial of two intervention groups this study tests the efficacy of COS-P compared to Care as Usual (CAU) in enhancing maternal sensitivity and child attachment in a community sample in the City of Copenhagen, Denmark. During the project a general population of an estimated 17.600 families with an infant aged 2-12 months are screened for two known infant mental health risks, maternal postnatal depression and infant social withdrawal. Eligible families (N?=?314), who agree to participate, will be randomly allocated with a ratio of 2:1 into the COS-P intervention arm and into CAU. Data will be obtained at inclusion (baseline) and at follow-up when the child is 12-16 months. The primary outcome is maternal sensitivity. Secondary outcomes include quality of infant attachment, language, cognitive and socioemotional development, family functioning, parental stress, parental mentalizing and maternal mental wellbeing. DISCUSSION:The potential implications of the experimental evaluation of an indicated brief group-based parenting educational program to enhance parental sensitivity and attachment are discussed. TRIAL REGISTRATION:ClinicalTrials.govID: NCT02497677 . Registered July 15 2015.

Project description:BackgroundThere is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admission jointly with their baby to a Mother and Baby Unit (MBU), a psychiatric inpatient ward, for assessment and treatment. However, MBUs do not yet offer formally evaluated, evidence-based parenting interventions as a matter of routine. This paper describes a study to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to evaluate a parenting and psychological intervention targeting the mother's and infant's wellbeing for mothers admitted to a MBU.Methods/designThis study is a multisite, single-blind feasibility trial with half the participants randomised to the Baby Triple P Positive Parenting Programme plus treatment as usual (TAU) and the other half randomised to TAU alone. Self-report and observer-rated assessments are collected at baseline, 10 weeks post-baseline and 6 months post-baseline. Participants are mothers admitted to a MBU in the Northwest of England or the Midlands. Participants are included if they are fluent in English to provide informed, written consent. Our objective is to determine whether we can recruit 66 women, randomise 60, and retain them in the intervention and study, and whether the intervention and study procedures are acceptable. As part of a nested process evaluation, qualitative interview data from trial participants and MBU staff will inform feasibility and acceptability. The feasibility of collecting data required to conduct an economic evaluation of the intervention will also be explored.DiscussionAlthough research has been conducted in relation to mothers with severe mental illness and MBUs, to our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake and retention alongside the potential efficacy of a parenting intervention for this population. This study is essential to examine the contextual challenges involved in this setting with this population and to identify any refinements required.Trial registrationISRCTN12765736 . Date of first registration: 2 February 2017.

Project description:IntroductionMost pregnant smokers report abruptly reducing their cigarettes per day (CPD) by ~50% after learning of pregnancy and making further smaller reductions over the remainder of their pregnancy. Laboratory and naturalistic studies with non-pregnant smokers have found that these types of reductions often lead to changes in smoking topography (i.e., changes in smoking intensity to maintain a desired blood-nicotine level). If pregnant women smoke more intensely, they may expose themselves and their offspring to similar levels of toxicants despite reporting reductions in CPD.MethodsPregnant and non-pregnant female smokers (n = 20 and 89, respectively) participated. At the experimental session, after biochemical confirmation of acute abstinence, participants smoked one usual brand cigarette ad lib through a Borgwaldt CReSS Desktop Smoking Topography device. Carbon monoxide (CO) and measures of nicotine withdrawal, craving, and reinforcement derived from smoking were also collected.ResultsThe two groups did not differ on demographic or smoking characteristics at screening, except nicotine metabolism rate, which as expected, was faster in pregnant smokers. Analyses suggest that none of the smoking topography parameters differed between pregnant and non-pregnant smokers, although pregnant smokers had a significantly smaller CO boost. Both groups reported similar levels of relief of withdrawal and craving after smoking, but other subjective effects suggest that pregnant smokers find smoking less reinforcing than non-pregnant smokers.ConclusionsPregnant smokers do not smoke cigarettes differently than non-pregnant women, but appear to find smoking comparatively less pleasurable.ImplicationsThis is the first study to assess smoking topography in pregnant women. Pregnant women appear to be at increased risk for smoking cigarettes with more intensity because of (1) their tendency to make significant abrupt reductions in the number of cigarettes they smoke each day after learning of pregnancy and (2) an increase in nicotine metabolism induced by pregnancy. Despite these changes, the present results suggest that pregnant women do not smoke cigarettes more intensely or in a way that causes more toxicant exposure, perhaps due to a reportedly less pleasurable smoking experience.

Project description:BackgroundImplementation of clinical health promotion (CHP) aiming at better health gain is slow despite its effect. CHP focuses on potentially modifiable lifestyle risks such as smoking, alcohol, diet, and physical inactivity. An operational program was created to improve implementation. It included patients, staff, and the organization, and it combined existing standards, indicators, documentation models, a performance recognition process, and a fast-track implementation model. The aim of this study was to evaluate if the operational program improved implementation of CHP in clinical hospital departments, as measured by health status of patients and staff, frequency of CHP service delivery, and standards compliance.MethodsForty-eight hospital departments were recruited via open call and stratified by country. Departments were assigned to the operational program (intervention) or usual routine (control group). Data for analyses included 36 of these departments and their 5285 patients (median 147 per department; range 29-201), 2529 staff members (70; 10-393), 1750 medical records (50; 50-50), and standards compliance assessments. Follow-up was measured after 1 year. The outcomes were health status, service delivery, and standards compliance.ResultsNo health differences between groups were found, but the intervention group had higher identification of lifestyle risk (81% versus 60%, p < 0.01), related information/short intervention and intensive intervention (54% versus 39%, p < 0.01 and 43% versus 25%, p < 0.01, respectively), and standards compliance (95% versus 80%, p = 0.02).ConclusionsThe operational program improved implementation by way of lifestyle risk identification, CHP service delivery, and standards compliance. The unknown health effects, the bias, and the limitations should be considered in implementation efforts and further studies.Trial registrationClinicalTrials.gov : NCT01563575. Registered 27 March 2012. https://clinicaltrials.gov/ct2/show/NCT01563575.

Project description:BACKGROUND:Community residential aftercare (step-down) services can ease the transition after a mental health hospital stay for patients with severe mental illness (SMI). AIMS:To investigate use of community and specialised mental health care services and costs in patients with SMI the first 12 months after discharge from a mental health hospital (MHH), comparing community residential aftercare (CRA) and treatment as usual. METHODS:An open parallel group randomised controlled trial with 41 participants. Data on use of specialist services (hospital, ambulant treatment and outpatient treatment) and community services (residential stays, home help, home care nursing, mental health consultation) were collected from specialist and community registers and health records. RESULTS:For the primary outcome, utilisation of community mental health services, the intervention group used, on average, 29% fewer hours (mean differences -?21.6 h, 95% CI -93.1 to 44.9, p?=?.096) with a cost saving of 29% (mean differences -?1845 EUR, 95% CI -8267 to 4171, p?=?.102), but the estimates were imprecise. For the secondary outcome, the study groups had the same total number of inpatient days (66 days), but the intervention group had on average of 13.4 fewer inpatient days in the mental health hospital (95% CI -29.9 to 0.9. p?=?.008). The number of inpatient admissions (mean difference?-?0.9 admissions, 95% CI -3.5 to 1.5, p?=?.224) and readmissions (-?0.8, 95% CI -2.5 to 0.9. p?=?.440) was lower in the intervention group. The intervention group had on average a total cost saving of 38.5% (mean differences -?23,071 EUR, 95% CI -45,450 to 3027. p?=?.057). A post hoc multivariable regression analysis controlling for baseline characteristics gave a reduction in total cost in favour of the intervention group of -?19,781 EUR (95% CI -44,072 to 4509, p=,107). CONCLUSION:In this study, it was not possible to draw a definite conclusion about the effect, due to the small sample and imprecision of the estimates. The direction of the results and size of the point estimate, in addition to findings in other studies, indicates that transferring patients ready for discharge from mental hospital to community residential aftercare can have the potential to reduce total consumption of health services and costs without increased hospital admissions. TRIAL REGISTRATION:Registered in clinicaltrials.gov ( NCT01719354 ).

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The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual.

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The Relevance of Infant Outcome Measures: A Pilot-RCT Comparing Baby Triple P Positive Parenting Program With Care as Usual.

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