CompletedNot Applicable

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

United States7 participantsStarted 2018-04-01

Plain-language 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.

Who can participate

Age range

3 Months – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.

Timeframe: 6 months

Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.

Timeframe: 6 months

Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.

Trial details

NCT IDNCT03447899

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

View on ClinicalTrials.gov More Non-Accidental Traumatic Head Injury to Child trials

Plain-language summary

Who can participate

Age range

3 Months – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.

Timeframe: 6 months

Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.

Timeframe: 6 months

Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.

Timeframe: 6 months

Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.