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

NCT ID: NCT03447899

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-06-30

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.

Conditions

Non-Accidental Traumatic Head Injury to Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ABC Intervention

The investigators will deliver the "Attachment and Biobehavioral Catch-up (ABC)" in the home weekly using live, in-room coaching, to give caregivers feedback as they use targeted skills during interactions with the child. The intervention will last 10 sessions. Study participants in both groups will complete study measures at baseline, 1 month, 3 months, post-intervention, 6 months, and 12 months.

Group Type: EXPERIMENTAL

Attachment and Biobehavioral Catch-up (ABC)

Intervention Type: BEHAVIORAL

Attachment and Biobehavioral Catch-up (ABC) is an in-home, 10-session, manualized parent-training program for children ages 6 months through 2 years who have experienced early adversity. ABC utilizes parent-child interactions to enhance positive interactions with the child through live coaching with particular focus on nurturing behaviors, following the child's lead, non-frightening behaviors. These behaviors include appropriate soothing and comforting when a child is distressed, responding to or imitating a child in a contingent way, and displaying warmth.

Standard of Care

Subjects will receive normal standard of care without the "Attachment and Biobehavioral Catch-up (ABC)".

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Attachment and Biobehavioral Catch-up (ABC)

Attachment and Biobehavioral Catch-up (ABC) is an in-home, 10-session, manualized parent-training program for children ages 6 months through 2 years who have experienced early adversity. ABC utilizes parent-child interactions to enhance positive interactions with the child through live coaching with particular focus on nurturing behaviors, following the child's lead, non-frightening behaviors. These behaviors include appropriate soothing and comforting when a child is distressed, responding to or imitating a child in a contingent way, and displaying warmth.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terri H Lewis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

IHEA101376

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

17-1221

Identifier Type: -

Identifier Source: org_study_id