Dataset Information

Online Intervention for Caregivers of Children with Early Traumatic Brain Injury: Pilot Trial.

ABSTRACT:

Objective

To assess the feasibility and acceptability of an online parenting-skills program for caregivers of young children with traumatic brain injury (TBI). Positive parenting contributes to recovery following early TBI and social and emotional development in typically developing children. Yet, few interventions have been designed to support psychosocial recovery and subsequent development after early TBI.

Methods

This study protocol was registered with clinicaltrials.gov (NCT05160194). We utilized an academic hospital's Trauma Registry to recruit caregivers of children, ages 0-4 years, previously hospitalized for TBI. The GROW intervention integrated six online learning modules with videoconference meetings with a coach to review and practice skills while receiving in vivo coaching and feedback. Interactive modules addressed strategies for responsive parenting, stimulating cognition, and managing parenting stress. Enrollment and retention rates served as feasibility metrics and satisfaction surveys assessed acceptability.

Results

18 of 72 families contacted (25%) consented, and 11 of 18 (61%) completed the intervention and follow-up assessments. All participants rated the intervention as helpful and indicated that they would recommend the intervention to others. All endorsed a better understanding of brain injury and how to optimize their child's recovery and development. Both coaches rated intervention delivery as comparable to traditional face-to-face treatment.

Conclusions

Low levels of uptake and initial engagement underscore the challenges of intervening with caregivers following early TBI, which likely were exacerbated due to the COVID-19 pandemic. High levels of acceptability and perceived benefit support the potential utility of GROW while highlighting the need to improve accessibility and early engagement.

SUBMITTER: Maggard BL

PROVIDER: S-EPMC9619775 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Online Intervention for Caregivers of Children with Early Traumatic Brain Injury: Pilot Trial.

Maggard Brianna L BL Gies Lisa M LM Sidol Craig A CA Moscato Emily L EL Schmidt Matthew M Landry Susan H SH Makoroff Kathi L KL Rhine Tara D TD Wade Shari L SL

Journal of pediatric psychology 20230301 3

<h4>Objective</h4>To assess the feasibility and acceptability of an online parenting-skills program for caregivers of young children with traumatic brain injury (TBI). Positive parenting contributes to recovery following early TBI and social and emotional development in typically developing children. Yet, few interventions have been designed to support psychosocial recovery and subsequent development after early TBI.<h4>Methods</h4>This study protocol was registered with clinicaltrials.gov (NCT0 ...[more]

PMID: 36240452

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Project description:ImportanceExecutive dysfunction after traumatic brain injury (TBI) in children is common and leads to significant short- and long-term problems in functioning across multiple settings. We hypothesized that improvements in short-term executive function would be maintained to 24 months after injury and that improvements would increase over time in a counselor-assisted problem-solving (CAPS) intervention.ObjectiveTo evaluate the efficacy of a CAPS intervention administered within 7 months of complicated mild to severe TBI compared with an Internet resource condition in improving long-term executive dysfunction.Design, setting, and participantsMultisite, assessor-blinded, randomized clinical trial at 3 tertiary pediatric hospitals and 2 tertiary general medical centers. Participants included 132 adolescents aged 12 to 17 years who sustained a moderate to severe TBI 1 to 7 months before study enrollment.InterventionWeb-based CAPS intervention.Main outcomes and measuresThe primary outcome was the parent-reported Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function. Secondary outcomes included the Behavioral Regulation Index (BRI) and Metacognition Index (MI) of the GEC.ResultsIn older (>14 to 17 years) adolescents, the CAPS intervention was associated with lower GEC ratings at 12 (β = -0.46; P = .03) and 18 (β = -0.52; P = .02) months after enrollment. Trends were also observed for older adolescents toward lower GEC ratings at 6 months (β = -0.40; P = .05), lower BRI ratings at 12 (β = -0.40; P = .06) and 18 (β = -0.47; P = .04) months, and lower MI ratings at 6 (β = -0.41; P = .05), 12 (β = -0.46; P = .03), and 18 (β = -0.50; P = .03) months. In younger (12-14 years) adolescents, no group differences were found on the GEC, BRI, or MI ratings.Conclusions and relevanceDelivery of the CAPS intervention early after TBI in older adolescents improves long-term executive function. This trial is, to our knowledge, one of the few large, randomized clinical treatment trials performed in pediatric TBI to demonstrate the efficacy of an intervention for management of executive dysfunction and long-term benefits of an intervention delivered soon after injury. Use of the CAPS intervention clinically should be considered; however, further research should explore ways to optimize delivery.Trial registrationclinicaltrials.gov Identifier: NCT00409448.

Project description:BackgroundTraumatic brain injury (TBI) outcomes are dependent on patients' biological sex (e.g., hormone levels) and sociocultural gender (e.g., norms, responsibilities). Informal caregivers additionally experience disruptions to identity and roles post-TBI. However, information on this topic remains largely unavailable to patients and caregivers.PurposeThis study aimed to determine the effectiveness of a one-time educational intervention on sex and gender influences in TBI for patients and informal caregivers.Materials and methodsWe conducted a pilot pre-test/post-test randomized control-group design study. Groups (i.e., passive, active and control) consisted a total of 16 persons with TBI and caregivers (75% persons with TBI, 63% women). Individual and group learning gains, and group-average normalized gain, were computed for three learning domains: knowledge, attitude, and skill. An intervention with an average normalized gain of ≥30% was considered effective. Educational intervention evaluation and qualitative comments post-participation were summarized.ResultsThe passive group demonstrated the highest average normalized gain across the three learning domains, including 100% for knowledge, 40% and 61% for attitude, and 37% for skill. The remaining groups did not reach an average normalized gain of ≥30%, except for the attitude domain of the control group (33% and 32%). Two key categories were identified qualitatively: (1) gendered self-expectations post-injury and (2) implications of gender stereotypes in rehabilitation, including the need for rehabilitation treatment to look beyond sex and gender. The post-participation educational session evaluation conveyed high appraisal of content, organization, and usability of the intervention.ConclusionA one-time passive educational intervention on sex and gender in TBI may improve knowledge, attitude, and skill on the topic of sex and gender among adults with TBI and caregivers. Obtaining knowledge and skill on sex and gender effects in TBI can potentially help persons with TBI and caregivers adapt to changes in roles and behaviours post-injury.

Project description:BackgroundGlobally, traumatic brain injury (TBI) is recognized as one of the most significant contributors to mortality and disability. Most of the patients who have experienced TBI will be discharged home and reunited with their families or primary caregivers. The degree of severity of their reliance on caregivers varies. Therefore, the task of delivering essential care to the patients becomes demanding for the caregivers. A significant proportion of caregivers expressed considerable burden, distress, and discontentment with their lives. Therefore, it is critical to comprehend the dynamic of TBI and caregivers to optimize patient care, rehabilitation, and administration. The effectiveness of the Brain Injury Family Intervention (BIFI) program tailored for caregivers of patients with TBI has been widely proven in Western countries. However, the impact is less clear among caregivers of patients with TBI in Malaysia.ObjectiveThis study aims to assess the effectiveness of BIFI in reducing emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of caregivers of patients with TBI at government hospitals in Malaysia.MethodsThis is a 2-arm, single-blinded, randomized controlled trial. It will be conducted at Hospital Rehabilitasi Cheras and Hospital Sungai Buloh. In total, 100 caregivers of patients with TBI attending the neurorehabilitation unit will be randomized equally to the intervention and control groups. The intervention group will undergo the BIFI program, whereas the control group will receive standard treatment. Caregivers aged ≥18 years, caring for patients who have completed >3 months after the injury, are eligible to participate. The BIFI program will be scheduled for 5 sessions as recommended by the developer of the module. Each session will take approximately 90 to 120 minutes. The participants are required to attend all 5 sessions. A total of 5 weeks is needed for each group to complete the program. Self-reported questionnaires (ie, Beck Depression Inventory, Positive and Negative Affect Schedule, Caregiver Strain Index, Satisfaction With Life Scale, and Family Needs Questionnaire) will be collected at baseline, immediately after the intervention program, at 3-month follow-up, and at 6-month follow-up. The primary end point is the caregivers' emotional distress.ResultsThe participant recruitment process began in January 2019 and was completed in December 2020. In total, 100 participants were enrolled in this study, of whom 70 (70%) caregivers are women and 30 (30%) are men. We are currently at the final stage of data analysis. The results of this study are expected to be published in 2024. Ethics approval has been obtained.ConclusionsIt is expected that the psychological well-being of the intervention group will be better compared with that of the control group after the intervention at 3-month follow-up and at 6-month follow-up.Trial registrationIranian Registry of Clinical Trials IRCT20180809040746N1; https://irct.behdasht.gov.ir/trial/33286.International registered report identifier (irrid)RR1-10.2196/53692.

Project description:BackgroundThe antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.MethodsSeverely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month.ResultsA total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.ConclusionBased on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

Project description:ObjectivesNew clinical practice guidelines for the management of mild traumatic brain injury (mTBI) emphasise that family physicians should proactively screen and initiate treatment for depression/anxiety, insomnia and headaches. This study aimed to evaluate the feasibility of delivering an implementation intervention to family physicians.DesignPilot cluster randomised controlled trial.SettingSpecialty outpatient clinic (recruitment) and primary care (implementation).Participants114 primary care clinics were randomised. These clinics were associated with 137 unique family physicians caring for 148 adult patients who sustained an mTBI within the previous 3 months and were seeking care for persistent symptoms.InterventionsPatients completed self-report screening measures for depression/anxiety, insomnia and headaches. A tailored letter that incorporates the patient's screening test results and associated treatment algorithms was sent to their family physician (or walk-in clinic). Physicians at clinics assigned to the control condition received a generic letter, without the screening test results.Primary outcome measuresFeasibility outcomes included the frequency of primary care follow-up, retention rates and reliability of patient recall of their physicians' actions (primary mechanistic outcome). The primary efficacy outcome was the Rivermead Post-Concussion Symptom Questionnaire (RPQ).ResultsMost patients (97.8%; 128 of 131) followed up at the primary care clinic they planned to. Retention rates were 88% (131 of 148) and 78% (116 of 148) at the 1-month and 3-month assessments, respectively. Agreement between patient recall of their physicians' actions and medical chart audits was moderate (intraclass correlation coefficient=0.48-0.65). Patients in the experimental group reported fewer symptoms on the RPQ compared with those in the control group, whose physician received a general letter (B=-4.0, 95% CI: -7.3 to -0.7).ConclusionsA larger trial will need to address minor feasibility challenges to evaluate the effectiveness of this guideline implementation tool for improving mTBI clinical outcomes and confirm the mechanism(s) of intervention benefit.Trial registration numberNCT03221218.

Dataset Information

Online Intervention for Caregivers of Children with Early Traumatic Brain Injury: Pilot Trial.

Objective

Methods

Results

Conclusions

Publications

Online Intervention for Caregivers of Children with Early Traumatic Brain Injury: Pilot Trial.

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