Non-Accidental Traumatic Head Injury to Child Clinical Trial
Official title:
Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma
Family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (AHT). However, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with AHT. The study was initially designed as a randomized controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with AHT. However, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with IRB approval). At that time, there were five participants and only one had been assigned to the intervention arm. Only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention. The investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention. The investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.
27 children (ages 3 months to 2 years) and their caregiver referred to the Non-Accidental Brain Injury Care Clinic at the Children's Hospital Colorado (CHCO) were recruited for participation in the study, 7 families consented. One family received the Attachment and Biobehavioral (ABC) intervention. One family discontinued participation. The data collection schedule was 1 month post-injury, 3 months, 6 months, 9 months, and 12 months. Outcomes in multiple dimensions, were assessed including clinical recovery, cognitive, language, and motor functioning, family functioning, caregiver mental health including anxiety, depression, competency, and stress. The investigators also examined service use over time. Analyses will assess trajectories of recovery for both groups using data for all time points. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06330831 -
Intensive Group Based CIMT for Young Children
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N/A |