Clinical trial NCT03447899: Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma
Official title: Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Accidental Traumatic Head Injury to Child
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 7
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.
timeFrame: 6 months
measure: Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.
timeFrame: 6 months
measure: Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual.
timeFrame: 6 months
measure: Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.
timeFrame: 9 months
measure: Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.
timeFrame: 12 months
measure: Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.
timeFrame: 9 months
measure: Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.
timeFrame: 12 months
measure: Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
measure: Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual.
timeFrame: 9 months
measure: Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation clusters of patient and family characteristics that benefit most from a parenting intervention component
timeFrame: 1 month, 3 month, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Terri H Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References: