Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma

Completed · Not applicable

Conditions studied: Non-Accidental Traumatic Head Injury to Child

In brief

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.

Key facts

Study ID

NCT03447899

Run by

University of Colorado, Denver

People needed

7

Starts

2018-04-01

Expected to finish

2020-06-30

Last updated by the study team

2020-09-10

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Those with significant disability that would inhibit participation in the intervention,
• Those scoring below 6 months on developmental measures will not be eligible.

Where it is running

• Children's Hospital of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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