Gaining Real-Life Skills Over the Web (GROW)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Positive Parenting Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05160194

90IFDV0003

Details and patient eligibility

About

Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries. GROW is designed to promote family and child coping and adjustment for caregivers.

Full description

This project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and their families. The incidence of TBI peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period. To address the unmet need of caregivers of infants and toddlers with TBI, the project uses a three-phase development process to generate proof of concept and initial proof of product. Phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight). During Phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing. Phase 3 involves a pilot of the GROW program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.

Enrollment: 18 patients

Sex: All

Ages: Under 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age at injury and enrollment: ages 0-4, inclusive
2. Overnight hospitalization for traumatic brain injury
3. Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
4. Language: English must be the primary spoken language in the home

Exclusion criteria

1. Does not reside with the caregiver at least half-time
2. The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
3. English is not the primary language spoken in the home
4. Families of children who are non-responsive or in a persistent vegetative state will also be excluded
5. Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
6. If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

GROW Intervention

Other group

Description:

Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.

Treatment:

Behavioral: Positive Parenting Intervention