Process evaluation of 'Brains Ahead!': an intervention for children and adolescents with mild traumatic brain injury within a randomized controlled trial.

OBJECTIVE: To investigate whether the 'Brains Ahead! Intervention for children and adolescents with mild traumatic brain injury' was implemented as intended. In addition, involvement in and satisfaction with the intervention among patients, caregivers and professionals delivering the intervention were studied. DESIGN: Mixed methods, prospective study. PARTICIPANTS: Children with mild traumatic brain injury and their caregivers, allocated to the intervention group of the randomized controlled trial in the 'Brains Ahead!' study, and the two professionals providing the intervention. INTERVENTION: The intervention consists of a standardized and individualized psychoeducational session with written take-home information, and follow-up telephone call(s). MAIN MEASURES: Registration forms, evaluation questionnaires for patients and caregivers and semi-structured interviews for professionals. DATA ANALYSIS: Qualitative data were categorized based on content. Quantitative data were reported as descriptive statistics. RESULTS: Fifty-five patients and caregivers out of 60 study-participants attended both sessions. All elements of the intervention were delivered to 53 study-participants. Evaluation questionnaires were completed by 21 of the 31 patients aged 12 years and older, and by 41 caregivers. Overall, the sessions were considered useful by 19 patients, 40 caregivers and both professionals. Reassurance, creating a better understanding and recognition of symptoms were rated as important aspects. On a scale from 1 to 10, the intervention was rated by children, caregivers and professionals with 7.6 (SD 1.2), 8.1 (SD .9) and 8.0 (SD .0), respectively. CONCLUSION: The 'Brains Ahead!' intervention was largely implemented as intended and the process evaluation revealed that it is considered feasible according to patients, caregivers and professionals.

Effectiveness of the Brains Ahead! Intervention: 6 Months Results of a Randomized Controlled Trial in School-Aged Children With Mild Traumatic Brain Injury.

OBJECTIVE: To examine the effectiveness of Brains Ahead!, a psychoeducational intervention aimed to prevent long-term problems with activities and participation in children after mild traumatic brain injury (mTBI). PARTICIPANTS: In total, 124 children, aged 6 to 18 years, diagnosed with mTBI and their caregivers. METHOD: After randomization, participants in the intervention group received a face-to-face psychoeducational session with written take-home information and follow-up telephone call(s). Participants in the control group received usual care, consisting of a concise information brochure. PRIMARY OUTCOME MEASURES: Activities and participation (Child and Adolescent Scale of Participation [CASP]). SECONDARY OUTCOMES: fatigue, postconcussive symptoms (PCSs), posttraumatic stress symptoms (PTSSs), and quality of life (QOL). RESULTS: Generalized Estimated Equation analyses showed that both groups improved over the first 6 months post-mTBI, but the intervention group did not differ significantly on the CASP. Mann-Whitney U tests showed that the intervention group reported significantly less fatigue, PCSs, and PTSSs and better QOL compared with the control group at 6 months post-MTBI. CONCLUSIONS: The Brains Ahead! intervention resulted in significant improvements compared with usual care in reducing fatigue, PCSs, and PTSSs and improving QOL. Lack of an effect on activities and participation may be due to the ceiling effect of the CASP.

Activities and Participation in the First 6 Months After Mild Traumatic Brain Injury in Children and Adolescents.

OBJECTIVE: To investigate the natural course of activities and participation of children up to 6 months after a mild traumatic brain injury (mTBI). METHODS: A prospective longitudinal cohort study with complete data sets of 231 children diagnosed with mTBI and their caregivers. MAIN MEASURES: Activities and participation assessed with the Child and Adolescent Scale of Participation (CASP) and the Children's Assessment of Participation and Enjoyment (CAPE) measured at 2 weeks, 3 months, and 6 months post-mTBI. Because of a ceiling effect, the primary outcome measure (CASP) was divided into deviant (not maximum score) or full functioning. RESULTS: Friedman's, Cochran's Q, and McNemar's tests (CASP) and repeated-measures analyses of variance (CAPE) showed significant increases in activities and participation between 2 weeks and 3 and 6 months after mTBI. Based on the parents' perspective, 67% of the children returned to full functioning at 6 months postinjury, with only 38% of the children describing themselves as functioning at their premorbid level. DISCUSSION: Findings indicate that most children return to maximum level of activities and participation over time after mTBI. In a substantial number of children, however, the level of activities and participation at 6 months postinjury is evaluated as lower than that of peers. The importance of investigating predictors for child and caregiver perspectives is emphasized.

Predictors of activities and participation six months after mild traumatic brain injury in children and adolescents.

OBJECTIVE: This study aimed to identify predictors of long-term consequences for activities and participation in children and adolescents with mild traumatic brain injury (mTBI). METHODS: A multicentre prospective longitudinal cohort study was conducted. The primary outcome measure was activities and participation measured with the Child and Adolescent Scale of Participation - CASP and completed by children (N = 156) and caregivers (N = 231) six months post-mTBI. The CASP items were categorized into home, community, school, and environment. Predictors were categorized according to the International Classification of Functioning, Disability and Health for Children and Youth. Predictors included pre-injury personal- and environmental factors, injury-related factors, symptoms, and resumption of activities in the first two weeks after mTBI. Univariate and multivariate logistic regression analyses were used to determine the predictive value of these factors. RESULTS: Results show that predictors differ across settings and perspectives (child or caregiver). Decreased activities and participation in children with mTBI can be predicted by adverse pre-injury behavioral functioning of the child (p < .000 - p = .038), adverse pre-injury family functioning (p = .001), lower parental SES (p = .038), more stress symptoms post-injury (p = .017 - p = .032), more post-concussive symptoms (p = .016 - p = .028) and less resumption of activities (p = .006 - p = .045). DISCUSSION: Pre-injury factors, more symptoms post-injury and less resumption of activities should be considered when children are screened for unfavorable outcomes. Additional factors may add to the prediction, but injury-related factors do not. It is recommended that future research explores psychosocial factors, such as coping styles, emotion-regulation, personality traits, social support, and other comorbid problems of both children and caregivers.

The Brains Ahead! intervention for children and adolescents with mild traumatic brain injury and their caregivers: rationale and description of the treatment protocol.

PURPOSE:: Approximately 20% of the children and adolescents after mild traumatic brain injury will not fully recover. They suffer long-term postconcussive symptoms and may experience limitations in activities and participation. Research suggests that early psychoeducational interventions may prevent long-term postconcussive symptoms. The Brains Ahead! intervention was developed to prevent long-term symptoms and, furthermore, to establish a more successful return to activities and participation after mild traumatic brain injury in children and adolescents. The intervention is currently being evaluated in a multicenter randomized controlled trial. RATIONALE:: Providing individualized information and personal advice in addition to standardized information about the injury and possible consequences early after the injury may enable patients and caregivers to recognize and anticipate on relevant symptoms at an early stage and to prevent problems in activities and participation. THEORY INTO PRACTICE:: The Brains Ahead! intervention is a psychoeducational intervention for children and adolescents who sustained a mild traumatic brain injury and for their caregivers. The patients will receive a partially standardized and partially individualized psychoeducational session and a telephone follow-up within the first two to eight weeks after the injury.

Activities and participation of children and adolescents after mild traumatic brain injury and the effectiveness of an early intervention (Brains Ahead!): study protocol for a cohort study with a nested randomised controlled trial.

BACKGROUND: Approximately 20 % of children and adolescents who have sustained mild traumatic brain injuries may experience long-term consequences, including cognitive problems, post-traumatic stress symptoms and reduced load-bearing capacity. The underestimation and belated recognition of these long-term consequences may lead to chronic and disruptive problems, such as participation problems in school and in social relationships. The aim of this study is to examine the level of activities and participation of children and adolescents up to 6 months after a mild traumatic brain injury and to identify possible outcome predictors. Another aim is to investigate the effectiveness of an early psychoeducational intervention and compare the results with those obtained with usual care. METHODS/DESIGN: This paper presents the Brains Ahead! study design, a randomised controlled trial nested within a multicentre, longitudinal, prospective cohort study. The eligible participants include children and adolescents between 6 and 18 years of age who have experienced a mild traumatic brain injury within the last 2 weeks. The cohort study will include 500 children and adolescents with a mild traumatic brain injury and their caregivers. A subset of 140 participants and their caregivers will be included in the randomised controlled trial. Participants in the randomised controlled trial will be randomly assigned to either the psychoeducational intervention group or the usual care control group. The psychoeducational intervention involves one face-to-face contact and one phone contact with the interventionist, during which the consequences of mild traumatic brain injury and advice for coping with these consequences to prevent long-term problems will be discussed. Information will be provided both verbally and in a booklet. The primary outcome domain is activities and participation, which will be evaluated using the Child and Adolescent Scale of Participation. Participants are evaluated 2 weeks, 3 months and 6 months after the mild traumatic brain injury. DISCUSSION: The results of this study will provide insight into which children with mild traumatic brain injury are at risk for long-term participation problems and may benefit from a psychoeducational intervention. TRIAL REGISTRATION: Netherlands Trial Register identifier NTR5153 . Registered on 17 Apr 2015.