Background
Background and objectives
Methods
Trial design
Participants
Recruitment and informed consent
Manualized family intervention
Week | Session (topic) | Topic of discussion | Facilitator |
---|---|---|---|
1 | Introduction | Information about the study; consent to participation; completion of baseline questionnaires; randomization; The homework assignment is given (90 min) | Nurse. If the family is randomized to the intervention group at the end of the session, the neuropsychologist will present the homework assignment |
2 | Making meaning | Presentation of the study and the individual sessions; expectations to the participants and the facilitator; making meaning of TBI/tSCI and psychoeducation; the homework assignment is reviewed and a new given; session rating scale (90 min) | Neuropsychologist |
3 | Shifting focus | The relationship between thoughts, feelings, and behaviour; the homework assignment is reviewed and a new given; session rating scale (90 min) | |
4 | Managing emotions | Learning to identify signs indicating an escalation of emotions and techniques to handle emotions; strategies for overcoming negative emotions; the homework assignment is reviewed and a new given; session rating scale (90 min) | |
5 | Communicating effectively | Talk-listening techniques and communication improving strategies; communication danger sings; the homework assignment is reviewed and a new given; session rating scale (90 min) | |
6 | Finding solutions | From problem-talk to solution-talk; problem-solving strategies; the homework assignment is reviewed and a new given; session rating scale (90 min) | |
7 | Boundary making | Understanding the importance of boundaries in the family; self-care; healthy family dynamics; the homework assignment is reviewed and a new given; session rating scale (90 min) | |
8 | Conclusion and farewell | Summary of learned skills; the homework assignment is reviewed; session rating scale; completion of post-intervention questionnaires (the facilitator leaves the room) (90 min) | |
34 (6 months after session 8) | Follow up | Completion of the follow-up questionnaires. The families receive the questionnaires in a stamped envelope. The families return the questionnaires to the nurse. They will receive a reminder if they forget to return the questionnaires and a follow up by phone if no answer | Nurse |
Control group
Outcomes
Questionnaires
Domain | Assessment | Test tool (outcome measure) | Administered by |
---|---|---|---|
Quality of life (QoL) | Generic QoL | All participants | |
The patient’s disease-specific QoL | QoL after Brain Injury (Qolibri) [54] | Participants with TBI | |
International Spinal Cord Injury QoL Basic Data Set [55] | Participants with tSCI | ||
Self-perceived burden | General burden, isolation, disappointment, emotional involvement, environment | Caregivers | |
Physical, emotional and financial burden | Self-Perceived Burden Scale (SPB) [57] | Participants with TBI or tSCI | |
Family dynamic | Flexibility | Family Adaptability and Cohesion Evaluation Scales-IV (FACES-IV) [58] | All participants |
Cohesion | |||
Communication | |||
Problem-solving abilities | Confidence | Problem-Solving Inventory (PSI) [59] | All participants |
Personal control | |||
Approach-avoidance | |||
Mental health | Depression | Patient Health Questionnaire-9 (PHQ-9) [60] | All participants |
Anxiety | Generalized Anxiety Disorder-7 (GAD-7) [61] | ||
Satisfaction with life | Satisfaction with Life Scale (SWLS) [62] | ||
Relationship | Relationship to relatives | All participants if a dyad | |
Resilience | Resilience and robustness | The Resilience Scale for Adults (RSA) [66] | All participants |