An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.
ABSTRACT: Background: Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. Materials and Methods: Forty-three families of a young child with T1D (1-6 years of age; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention. We assessed intervention feasibility with rates of attrition, intervention attendance, and fidelity to the treatment manual. We assessed acceptability with treatment satisfaction surveys and qualitative interviews (from a subset of completers; n?=?10) about intervention acceptability, facilitators, and challenges. Results: Study attrition was 21%, including long-term follow-up (16% before or during the treatment phase). On average, parents attended 94% of intervention sessions and fidelity to the treatment manual was 89%. Intervention completers reported high satisfaction with the treatment groups (89% average satisfaction rating). Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support, whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members. Conclusions: The REDCHiP intervention demonstrated initial feasibility and acceptability. Next steps include determining the intervention's impact on objective parent and child outcomes (e.g., glycemic control, parental FH, and parental stress/distress) as well as large-scale efficacy testing.
Project description:BACKGROUND:Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information. OBJECTIVE:The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice. METHODS:The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1). RESULTS:Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26%, n=32). As such, 24% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59%) unique users, divided into 12 (38%) frequent users, 9 (28%) incidental users, and 11 (34%) low-frequent users. Of the total of 44 professionals, 34 (77%) logged in, and 32 (73%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents' frequency of logging on (?=.282, P=.03) and page-views (?=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F3,101=.49, P=.49). CONCLUSIONS:The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested. TRIAL REGISTRATION:Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6).
Project description:Problems with adherence are common among adolescents with type 1 diabetes (T1D), who must follow a complex treatment regimen. Positive psychology interventions increase adherence and improve health outcomes in adults with chronic conditions; however, they have not been translated to pediatric populations. We evaluated the acceptability and feasibility of Check It!, a positive psychology intervention to improve adherence in adolescents with T1D. Adolescents with T1D and their parents were randomized to a positive psychology intervention (via phone or text message) or an attention control (education) group. Exit interviews and satisfaction surveys were conducted with adolescents (n=63) and parents (n=55) to assess the acceptability and feasibility of Check it! from a representative sample of each group. Chi-square, t-tests, ANOVA and content analysis methods were used to analyze data. Parents and adolescents indicated interest in the intervention, and enrollment numbers support feasibility. In terms of intervention delivery, we identified challenges in implementing the positive psychology reminders to adolescents, particularly in the phone group. Parents in the positive psychology group appreciated the reminders to provide affirmations to their children, and adolescents enjoyed the affirmations and reported using the positive psychology exercises. Regarding acceptability, participants in both groups reported high satisfaction with the intervention overall. Participants reported favorable experiences with Check It!, and findings indicate that text messages are more feasible than phone calls for interventions with adolescents. Overall, a positive psychology intervention delivered with automated text messages is feasible and acceptable to adolescents with T1D and their parents.
Project description:BACKGROUND:Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE:Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN:Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS:Two National Health Service health trusts and local authority children's social care. PARTICIPANTS:Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION:HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES:Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES:(i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES:child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS:Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95%?CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION:HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER:ISRCTN14573230.
Project description:This study aims to test an evidence-based parenting program offered in churches among Filipino-American parents and estimate effect size for a fully powered trial.Twenty-two parents of children aged 6 to 12 years were randomly assigned to either an intervention or a waiting-list control group. Parents' perceptions of child behavior, parenting practices, and parenting stress were obtained at baseline. Parents in the experimental group attended The Incredible Years School Age Program, which consisted of 12 weekly 2-hour sessions. A follow-up assessment was performed after the intervention and 12 weeks later. The intervention was subsequently repeated with the control group. Satisfaction was assessed with a 40-item measure. Analysis of covariance was used to compare the intervention group postintervention versus the control group. Paired t-tests compared mean parenting practices, parenting stress, and child behavior outcomes. Satisfaction was assessed descriptively.Twenty-two parents completed all assessments and the intervention. Analysis of variance comparing intervention and control groups with repeated measures (pre- and post-test measures) revealed that the program has a positive impact on parenting stress, parenting practices (physical punishment, positive verbal discipline), and parent's perception of their child's behavior (internalizing symptoms, externalizing symptoms, and number of problematic behaviors). Analyses of all participants comparing pre- and post intervention revealed improvements in parenting stress, positive verbal discipline, and child externalizing and total problem behaviors. Families reported high satisfaction with the content and format of the intervention.Results support the feasibility of providing an evidence-based parenting program to Filipino parents in churches to prevent future behavioral health problems.
Project description:OBJECTIVE:To assess the feasibility and acceptability of using digital technology for Proactive Assessment of Obesity Risk during Infancy (ProAsk) with the UK health visitors (HVs) and parents. DESIGN:Multicentre, pre- and post-intervention feasibility study with process evaluation. SETTING:Rural and urban deprived settings, UK community care. PARTICIPANTS:66 parents of infants and 22 HVs. INTERVENTION:ProAsk was delivered on a tablet device. It comprises a validated risk prediction tool to quantify overweight risk status and a therapeutic wheel detailing motivational strategies for preventive parental behaviour. Parents were encouraged to agree goals for behaviour change with HVs who received motivational interviewing training. OUTCOME MEASURES:We assessed recruitment, response and attrition rates. Demographic details were collected, and overweight risk status. The proposed primary outcome measure was weight-for-age z-score. The proposed secondary outcomes were parenting self-efficacy, maternal feeding style, infant diet and exposure to physical activity/sedentary behaviour. Qualitative interviews ascertained the acceptability of study processes and intervention fidelity. RESULTS:HVs screened 324/589 infants for inclusion in the study and 66/226 (29%) eligible infants were recruited. Assessment of overweight risk was completed on 53 infants and 40% of these were identified as above population risk. Weight-for-age z-score (SD) between the infants at population risk and those above population risk differed significantly at baseline (-0.67 SD vs 0.32 SD). HVs were able to collect data and calculate overweight risk for the infants. Protocol adherence and intervention fidelity was a challenge. HVs and parents found the information provided in the therapeutic wheel appropriate and acceptable. CONCLUSION:Study recruitment and protocol adherence were problematic. ProAsk was acceptable to most parents and HVs, but intervention fidelity was low. There was limited evidence to support the feasibility of implementing ProAsk without significant additional resources. A future study could evaluate ProAsk as a HV-supported, parent-led intervention. TRIAL REGISTRATION NUMBER:NCT02314494 (Feasibility Study Results).
Project description:There 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.This 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.Although 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.ISRCTN12765736 . Date of first registration: 2 February 2017.
Project description:Preterm birth affects 8% to 11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positive impact on early motor and cognitive development and on parental well-being. However, these programs are often difficult to implement in a real-life setting due to lack of resources. Hence, our multidisciplinary team developed Mieux Agir au Quotidien (MAQ) to teach developmentally supportive care to parents of preterm infants with the goal of improving child development and parental outcomes. Our intervention included 3 in-person workshops that occurred prior to hospital discharge and a Web-based platform with written and videotaped materials that addressed 5 main themes: (1) infant behavioral cues, (2) flexion positioning; (3) oral feeding support, (4) parent-infant interactions, and (5) anticipation of developmental milestones.This study aimed to test the feasibility and acceptability of the intervention by parents of preterm infants and assess clinical benefits on child neurodevelopment and parental outcomes during the first year of life.A total of 107 infants born at <30 weeks and admitted to Sainte-Justine Hospital neonatal intensive care unit and their parents were enrolled in a nonrandomized controlled before-and-after interventional study (intervention n=55, comparison n=52). Acceptability of the program was assessed with a user satisfaction questionnaire. When the infants were at 4 months' corrected age, all parents completed questionnaires on infant temperament, parenting stress, sense of competence, and parenting satisfaction. At 12 months' corrected age, neurodevelopmental testing was performed on infants using the Alberta Infant Motor Scale and the Bayley Scales of Infant and Toddler Development, Third Edition. Comparisons between the 2 groups were done using independent t tests, Wilcoxon rank-sum tests, and Fisher exact tests.The majority of parents (43/45) were satisfied with the intervention program and all would recommend MAQ to others. MAQ met their need for evidence-based information that proved useful to support their child development. No difference in parental or child neurodevelopmental outcomes was detected in this pilot study for most outcomes except for higher median scores for parental coercive behaviors in the intervention group, although proportions scoring in the coercive range did not differ.Acceptability of the program was high among parents thus supporting the relevance of such intervention. A larger study using a randomized controlled trial design is needed to better document impact on parent and children and investigate how Web-based technologies can efficiently complement individualized intervention to alleviate the burden on health care resources.
Project description:Background:Untreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH. Methods:A two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population. Discussion:This trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial. Trial registration:ISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.
Project description:Objective To conduct a single-arm pilot study assessing the feasibility and acceptability of a 30-day parent-focused mindfulness and psychosocial support mobile app intervention for parents of children with chronic pain. Methods Thirty parents completed the intervention, which included a mindfulness curriculum, peer support videos, and written psychoeducational content. Twelve healthcare providers also assessed the app and provided feedback. Feasibility was assessed by server-side documented usage on ?50% of the days in the intervention period and completion of ?70% of the mindfulness content. Parent and provider acceptance were assessed by ?70% of participants rating each acceptance test question as ?5 on a 7-point Likert scale. Parents completed measures of solicitousness, stress, mindful parenting, and resilience prior to and following the intervention. Results Feasibility results were mixed: parents completed mindfulness content on an average of 11.2?days during the intervention period, slightly under the pre-established criterion. However, parents completed an average of 72.1% of the content, which met feasibility criterion. Acceptance criteria were met for the majority of parent acceptance test questions and all of the provider acceptance test questions. Exploratory analyses of the psychosocial measures revealed significant decreases in parental solicitous behavior and perceived stress, and a significant increase in mindful parenting. Conclusions The current study extends the emerging body of research on mindfulness-based interventions for parents of children with chronic illness and suggests that it may be acceptable to deliver this content through a mobile device. Future research is needed to assess the intervention's efficacy compared to standard of care.
Project description:Objective:To develop a Therapist-assisted Online Parenting Strategies (TOPS) program that is acceptable to parents whose adolescents have anxiety and/or depressive disorders, using a consumer consultation approach. Methods:The TOPS intervention was developed via three linked studies. Study 1 involved content analysis of feedback from participants (N?=?56) who received a web-based preventive parenting intervention called Partners in Parenting (PiP), as part of a randomised controlled trial. Study 2 involved stakeholder consultations with: (i) parents of adolescents aged 12-17?years (N?=?6), and (ii) mental health professionals (N?=?28), to identify adaptations to PiP that are required to make it appropriate for parents of adolescents with anxiety and depressive disorders. Study 3 was a pilot of the resulting TOPS program with professionals (N?=?10) and a small sample of parents (N?=?3) to assess the acceptability of the program content and format that involved online modules and videoconferencing coaching. Results:Study 1 indicated a need for an enhanced program for parents whose adolescents are experiencing anxiety and depressive disorders, while findings from Study 2 informed the content of the new TOPS program. In Study 3, mental health professionals endorsed the structure and content, while parents affirmed the acceptability of the TOPS program. Feedback from Studies 2 and 3 indicated that the therapist-coach was a valuable resource to (i) provide parents with strategies that are associated with the alleviation of adolescent anxiety and depression, (ii) discuss difficulties in implementing these strategies, (iii) assist parents with overcoming these difficulties; and (iv) support the development of a relapse prevention plan. Professionals felt that the TOPS program would broaden parental knowledge about how to recognise and respond to symptoms of clinical anxiety and depression in their adolescent. Conclusions:This study provided preliminary support for the feasibility, acceptability and perceived usefulness of the TOPS program.