A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial.
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SUBMITTER: Martyn-Nemeth P
PROVIDER: S-EPMC6938021 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
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A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial.
Martyn-Nemeth Pamela P Duffecy Jennifer J Quinn Laurie L Park Chang C Mihailescu Dan D Penckofer Sue S
Trials 20191230 1
<h4>Background</h4>In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than o ...[more]
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Project description:ObjectiveTo evaluate the efficacy of a new video-based telehealth intervention to reduce hypoglycemia fear in parents of young children with type 1 diabetes.MethodsWe randomized 42 parents to either immediate treatment (reducing emotional distress for childhood hypoglycemia in parents, REDCHiP; n = 22) or a waitlist control (WAITLIST; n = 21) condition. REDCHiP parents completed a 10-session video-based telehealth intervention, while WAITLIST parents continued in usual care. After 14-weeks, WAITLIST parents completed the telehealth treatment. We examined for between group changes in parental hypoglycemia fear and parenting stress (n = 18 per condition), 3-month maintenance of treatment effects for parents randomized to REDCHiP (n = 15), and pre-post changes for the entire sample (n = 36).ResultsMostly mothers participated (97.6%). They reported a mean age of 35.2 ±?5.0?years at pre-treatment. Children were 4.4 ±?1.4?years old and 59.5% boys. Between group comparisons showed a significant reduction in hypoglycemia fear (P =?.04) and a trend toward reduction in parenting stress-frequency (P =?.092) for REDCHiP parents compared to WAITLIST parents. After the three-month maintenance period, REDCHiP parents reported significant reductions in hypoglycemia fear, parenting stress-frequency, and parenting stress-difficulty (P's <?.01) compared to pre-treatment. When all parents received the telehealth treatment, we also observed significant reductions in hypoglycemia fear, parenting stress-frequency, and parenting stress-difficulty (P's <?.001), and sensitivity analyses revealed a significant reduction in child glycated hemoglobin for children who entered the treatment above target (P <?.05).ConclusionOur new video-based telehealth intervention appears to reduce hypoglycemia fear and parenting stress and may help parents of very young children with T1D to better achieve optimal child glycemic control when children are above target.
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Project description: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.
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Project description:The purpose of this study was to explore perceptions of the first dose of a cognitive behavioral sleep self-management intervention (CB-sleep) among young adults aged 18 to 25 years with type 1 diabetes (T1D). We used a qualitative descriptive approach to conduct in-depth semi-structured focused interviews with a purposive sample of 16 young adults with T1D, transitioning from adolescence to early adulthood. Interviews were audio-recorded, transcribed verbatim, and analyzed using qualitative content analysis. Participants described their sleep knowledge (previous, new, and additional), sleep health goals, along with barriers and facilitators of the CB-sleep intervention. Based on these results, we suggest CB-sleep is a useful modality with the potential to support sleep self-management in young adults with T1D during this complex life transition. Furthermore, CB-sleep could be incorporated into an existing diabetes self-management education and support program after pilot testing and determining efficacy to improve sleep and glycemic health.
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Project description:BACKGROUND:Fear of hypoglycemia is common in parents of young children with type 1 diabetes (T1D), but little is known about the specific fears that parents most often experience. Hypoglycemia fear has been associated with poorer glycemic control in older children, though not yet studied in a large cohort of very young children. MATERIALS AND METHODS:Parents of 549 children <7?years (mean 5.2?±?1.2?years [19% <3?years]) with a mean diabetes duration of 2.4?±?1.0?years (range 1-6?years) and mean HbA1c 8.2%?±?1.1% (66?±?12?mmol/mol) registered in the T1D Exchange completed the worry scale of the Hypoglycemia Fear Survey modified for parents (HFS-P). RESULTS:Mean parental fear of hypoglycemia worry score was 36.1?±?23.1 (possible range 0-100), with most frequent worries related to the child having a low while asleep and the child not recognizing a low. The mean worry score was not associated with the child's age, glycemic control, or recent severe hypoglycemic event. Parental worries about lows while sleeping were significantly higher in pump users than non-users (61% vs. 45%; P?<?.001), and tended to be higher in CGM users than non-users (62% vs 51%; P?=?.02). CONCLUSIONS:The greatest worries of parents of young children with T1D were related to hypoglycemia during sleep and other times/circumstances during which it would be difficult to detect hypoglycemia. Using advanced diabetes technologies may be an effort to temper fears about hypoglycemia during sleep, though the directionality of this relationship is undetermined. Additional studies can clarify this association and leverage use of diabetes technologies to improve glycemic control.
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Project description:BackgroundThis study describes the process evaluation of an intervention developed to reduce fear of falling (FoF) after hip fracture, within an inpatient geriatric rehabilitation setting. This 'FIT-HIP intervention' is a multicomponent cognitive behavioral intervention, conducted by physiotherapists and embedded in usual care in geriatric rehabilitation in the Netherlands. A previous study (cluster randomized controlled trial) showed no beneficial effects of this intervention when compared to usual care. The aim of this study was to gain insight into factors related to the intervention process that may have influenced the effectiveness of the intervention.MethodsThis process evaluation was conducted using an observational prospective study design. Based on quantitative and qualitative data derived from session logs, evaluation questionnaires and interviews, we addressed: 1] recruitment and reach; 2] performance according to protocol; 3] patients' adherence; and 4] opinions of patients and facilitators on the intervention. Participants in this study were: a) patients from 6 geriatric rehabilitation units, who were invited to participate in the intervention (39 adults aged ≥65 years with hip fracture and FoF) and; b) intervention facilitators (14 physiotherapists and 8 psychologists who provide coaching to the physiotherapists).ResultsThirty-six patients completed the intervention during inpatient geriatric rehabilitation. Apart from cognitive restructuring and telephonic booster (which was not provided to all patients), the intervention was performed to a fair degree in accordance with protocol. Patients' adherence to the intervention was very good, and patients rated the intervention positively (average 8.1 on a scale 0-10). Although most facilitators considered the intervention feasible, a limited level of FoF (possibly related to timing of intervention), and physiotherapists' limited experience with cognitive restructuring were identified as important barriers to performing the intervention according to protocol.ConclusionsThe FIT-HIP intervention was only partly feasible, which may explain the lack of effectiveness in reducing FoF. To improve the intervention's feasibility, we recommend selecting patients with maladaptive FoF (i.e. leading to activity restriction), being more flexible in the timing of the intervention, and providing more support to the physiotherapists in conducting cognitive restructuring.Trial registrationNetherlands Trial Register: NTR5695 (7 March 2016).
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Project description:ObjectiveTo evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and sleepiness.Research design and methodsWe conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires.ResultsCaregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09).ConclusionsOur results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.
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Project description:PurposeThe authors examined associations between preschoolers' daily glycemic variability, parents' report of hypoglycemia fear, and preschoolers' daily moderate to vigorous physical activity (MVPA) and sedentary behavior (SB) in 25 families of preschoolers with type 1 diabetes.MethodsParents completed a valid measure of hypoglycemia fear, and their child wore an accelerometer for up to 7 days. Parents provided glucose data from their child's devices. The authors used multiple regression and multilevel modeling to analyze their data.ResultsPreschoolers (mean age 4.2 [1.7] y; 50% boys) engaged in a mean of 154.5 (59.6) and 339.2 (85.1) minutes of MVPA and SB per day, respectively, and parents reported relatively low levels of hypoglycemia worry and avoidance behaviors. Preschoolers' SB (r = .19, P = .02) and MVPA (r = -.20, P = .01) levels were significantly correlated with parental hypoglycemia worry scores but not with parents' hypoglycemia behavior scores (P = .15 and P = .92, respectively). While multilevel models did not show an association between MVPA and preschoolers' glycemic variability, preschoolers who engaged in more daily SB experienced higher glycemic variability (P = .04).ConclusionsResearch exploring MVPA, SB, and parental hypoglycemia fear in preschoolers with type 1 diabetes could have important clinical implications because it may reveal modifiable treatment targets that can impact preschoolers' health and activity patterns.
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Project description:IntroductionIt is crucial to understand psychosocial outcomes in children and adolescents with type 1 diabetes (T1D) and their families to provide optimal family-centered care. Hence, the aim of this study was to explore psychosocial outcomes in young people with T1D and their parents using currently available glucose monitoring devices in a real-life clinic setting.MethodsChildren and adolescents aged 2-18 years with T1D for more than 6 months and their parents were recruited into a cross-sectional study to complete the Hypoglycemia Fear Survey (HFS) and the Pediatric Quality of Life Inventory (PedsQL) Generic Score Scales, Diabetes Module and Family Impact Module. Demographics and diabetes-specific parameters were obtained from medicals records.ResultsFifty-nine children and adolescents (mean age 15.1 ± 3.0 years) and 49 parents of children (mean age of children 12.5± 3.3 years) of which 44 were child-parent dyads completed the questionnaires. Parents had a higher mean (SD) FOH total and worry subscore than children, total score was 37.9 (14.6) vs. 32.2 (11.9), p = 0.047 and worry subscore was 17.8 (10.4) vs. 12.8 (9.0), p = 0.01. Furthermore, lower parental diabetes-specific QoL score was observed in parents, 78.8 (12.2) vs. 82.7 (10.3), p=0.02. No difference in FOH and QoL between real-time continuous glucose monitoring (rtCGM) and intermittently scanned glucose monitoring (isCGM) users and users of devices with and without alerts was observed. In isCGM users (n=36 completing the child questionnaires, n=33 completing parent questionnaires), higher parental FOH and lower parental diabetes-specific QoL correlated with higher scanning frequency, r = 0.399, p = 0.021, and r = -0.464, p = 0.007 respectively. No significant correlation was documented between scanning frequency and child questionnaire scores.ConclusionsParents are more likely to perceive higher levels of psychosocial burden related to their child's diabetes than children and adolescents with T1D, especially parents of younger children. This highlights the need for family-based education and treatment resources to support parents in diabetes management in addition to rapidly advancing diabetes technology. In isCGM users, higher parental FOH and lower parent-perceived QoL correlated with a higher scanning frequency, indicating the potential impact of glucose monitoring modality on psychosocial outcomes or vice versa.
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Project description:BackgroundAlthough largely preventable through diet management and topical fluoride use, early childhood caries (ECC) often progresses to severity that necessitates surgical repair. Yet repair often fails to mitigate caries progression. Needed is an effective behavioral intervention to address underlying behavioral causes.MethodsThis randomized controlled trial will evaluate the efficacy of a behaviorally focused, family-centered intervention, the MySmileBuddy Program (MSB Program), to reduce ECC progression in high-risk preschoolers in New York City. Recruitment will target 858 children ages 24-71 months with ECC and their parents from primary care medical and dental clinics. The study aims to assess the MSB Program's efficacy to: (1) decrease ECC progression measured 12-months post-randomization; and (2) enhance adoption of a low cariogenic diet and twice-daily fluoridated toothpaste use compared to control group. Potential causal pathways (mediators and moderators) will be explored. The MSB Program equips community health workers (CHWs) with an app that facilitates multilevel risk assessment and provides motivational interviewing-based counseling to inform parents about the caries process, develop personalized goals, and create family-level action plans to achieve targeted behaviors. Social support from CHWs (4 interactions during the 6-month intervention, supplemented by up to 4 in-person/remote contacts throughout the 12-month study period, based on need) is bolstered by automated text messages. Participants will be randomized to a Control Group (paper-based educational handout plus toothbrushes and fluoridated toothpaste for the child) or Intervention Group (MSB Program, two tooth-brushing observations with feedback and instruction, and toothbrushes and toothpaste for the entire family). All children will receive visual ICDAS dental examinations and parents will complete study measures at baseline and 12-months. An incentive up to $150 plus round-trip transit cards ($5.50 value) will be provided.DiscussionThis study hypothesizes that the MSB Program can reduce ECC progression in a high-risk population. Sufficient incentives and a focus on establishing rapport between participants and CHWs are anticipated to mitigate recruitment and retention challenges. If successful, this study will advance the long-term goal of reducing pediatric oral health disparities by demonstrating the efficacy of an acceptable and feasible intervention that shifts attention from dental repair to behavioral risk mitigation.Trial registrationTrial registration was completed on 4/13/2021 through the U.S. National Library of Medicine ClinicalTrials.gov website (Identifier: NCT04845594).
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Project description:BackgroundElevated neck pain prevalence among skydivers is associated with exposure to repeated parachute opening shock (POS). A study is planned to evaluate a preventive free fall acrobatics intervention, but prior assessment of the protocol is necessary given the complex and safety-critical study environment.AimTo validate an intervention protocol to reduce POS neck loads.MethodsA protocol was developed based on observational data and theoretical calculations. Six experts rated each component of the protocol on a four-point Likert scale, regarding relevance, simplicity/feasibility and safety, and responded to open-ended questions. Two iterations were made, each followed by consensus panel protocol revisions. The content validity index (CVI) was used to quantify ratings. A measure of universal agreement (CVI/UA) was computed as the proportion of components that achieved a rating ?3 by all raters. For safety, a high-sensitivity CVI/UA was computed with a rating of no <4 (highest score) as acceptable.ResultsCVI/UA for relevance increased from 0.80 in the first assessment to 1.00 in the second; for simplicity from 0.50 to 0.63; and for safety from 0.70 to 1.00. High-sensitivity CVI/UA for safety increased from 0.10 to 0.75. Responses to open-ended questions included safety concerns for free fall stability, altitude awareness and concerns over comprehensibility.ConclusionsThe proposed protocol has been improved in assessed relevance, simplicity and safety, and is considered validated for the start of the empirical trial. To what degree complex interventions should be preceded by open prevalidation is discussed.
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