Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any - 2 |
Updated: | 5/18/2018 |
Start Date: | April 1, 2018 |
End Date: | February 1, 2020 |
Contact: | Matthew J Steinbeiss, BA |
Email: | matthew.steinbeiss@childrenscolorado.org |
Phone: | 720-777-4800 |
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 utilizes a randomized
controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to
improve outcomes for families and children with AHT. The investigators will examine outcomes
in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and
service usage over time compared to patients not receiving the intervention. The
investigators will then examine characteristics of patients and families that are best suited
for this behavioral health intervention.
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 utilizes a randomized
controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to
improve outcomes for families and children with AHT. The investigators will examine outcomes
in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and
service usage over time compared to patients not receiving the intervention. The
investigators will then examine characteristics of patients and families that are best suited
for this behavioral health intervention.
60 children (ages 6 months to 2 years) and their caregiver referred to the Non-Accidental
Brain Injury Care Clinic at the Children's Hospital Colorado (CHCO) will recruited for
participation in the study. Consenting patients will be randomized to receive care as usual
or to receive the Attachment and Biobehavioral Catch-up (ABC) intervention. Data for all
participants will be collected at 1 month, 3 months, 6 months, 9 months, and 12 months.
Outcomes in multiple dimensions, will be assessed including clinical recovery, cognitive,
language, and motor functioning, family functioning, caregiver mental health including
anxiety, depression, competency, and stress. The investigators will also examine service use
over time. Analyses will first assess trajectories of recovery for both groups using data for
all time points. Analyses assessing the intervention will focus on caregiver mental health
features, family functioning, service use, and child scores on language motor, cognitive, and
socio-emotional measures. Finally, injury, initial family, and child functioning data will be
aggregated in a latent class approach to assess what family and child characteristics may be
most amenable to improvement in general and for the intervention group in particular.
Brain Injury Care Clinic at the Children's Hospital Colorado (CHCO) will recruited for
participation in the study. Consenting patients will be randomized to receive care as usual
or to receive the Attachment and Biobehavioral Catch-up (ABC) intervention. Data for all
participants will be collected at 1 month, 3 months, 6 months, 9 months, and 12 months.
Outcomes in multiple dimensions, will be assessed including clinical recovery, cognitive,
language, and motor functioning, family functioning, caregiver mental health including
anxiety, depression, competency, and stress. The investigators will also examine service use
over time. Analyses will first assess trajectories of recovery for both groups using data for
all time points. Analyses assessing the intervention will focus on caregiver mental health
features, family functioning, service use, and child scores on language motor, cognitive, and
socio-emotional measures. Finally, injury, initial family, and child functioning data will be
aggregated in a latent class approach to assess what family and child characteristics may be
most amenable to improvement in general and for the intervention group in particular.
Inclusion Criteria:
- Children who have experienced AHT as determined by the CHCO Child Protection Team
- Caregivers who speak English
- Families who live in the Denver Metro area and,
- Child-victim age between 3 months and 2 years of age
Exclusion Criteria:
- Those with significant disability that would inhibit participation in the
intervention,
- Those scoring below 6 months on developmental measures will not be eligible.
We found this trial at
1
site
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials