Gaining Real-Life Skills Over the Web

NCT05160194 | Completed

• 1 other identifier: 90IFDV0003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Parent-Child Relations; Parenting

Outcome Measures

Primary Outcomes (8)

• Center for Epidemiologic Studies Depression(CES-D) Scale Change

  Measuring caregiver psychological distress, the CES-D consists of 20 items that are rated on a 4-point likert scale (from 1: rarely or none of the time to 4: most or all of the time). Scores range from zero to sixty. Higher scores indicated a higher frequency of depressive symptoms during the last week.

  Pre-Intervention and Immediately Post-Intervention

• Parenting Stress Index (PSI) Change

  The study team used the 36 item short form PSI to measure caregiver stress. Using a 4-point likert scale, the stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.

  Pre-Intervention and Immediately Post-Intervention

• Patient-Reported Outcomes Measurement Information System Change

  The study team used only the Sleep, Stress, and Anxiety Measures which are rated on a 5-point likert scale. Each measure has a range in score from 7 to 35 with higher scores indicating greater severity.

  Pre-Intervention and Immediately Post-Intervention

• Family Burden of Injury Interview (FBII) Change

  The FBII measures family burden. Open-ended answers are coded Yes/No and are given a stress rating of 0 (not at all)-5(extremely stressful). Caregiver responses are averaged to provide an index of injury-related family burden.

  Pre-Intervention and Immediately Post-Intervention

• MacArthur-Bates Communicative Development Inventories (MB-CDI) Change

  Using the short form MB-CDIs to measure child language abilities, the scoring scale is a minimum of 0- maximum of 310 with greater scores showing better language abilities.

  Pre-Intervention and Immediately Post-Intervention

• Caregiver-Child Observation Change

  Using the Parent/Child Toy Play Ratings in the Play and Learning Strategies (PALS) manual, 6 domains (warmth, contingent responsiveness, demonstration/physical teaching, verbal stimulation/scaffolds, restrictions, and negativity/intrusiveness) are rated on scales of 1 to 5 with 1 being the worst rating and 5 being the best.

  Pre-Intervention and Immediately Post-Intervention

• GROW Satisfaction Survey

  Satisfaction with intervention measured in both 5-point likert scale ratings (with higher values showing greater satisfaction) and open-ended feedback about participant experience in the program.

  Immediately Post-Intervention

• Background & Family Information Form

  Demographics rehabilitation services

  Pre-Intervention

Study Arms (1)

GROW Intervention

OTHER

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

Behavioral: Positive Parenting Intervention

Interventions

Positive Parenting Intervention BEHAVIORAL

The highly interactive GROW Program consists of 5 core modules and 1 optional, supplemental session. Each session is expected to take 15-20 minutes to complete, and at the end of each module, parents record a 5 minute "special play time" video interacting with their child to demonstrate the skills they learned in the session. Each online module is followed by a meeting with a trained therapist who will discuss their "special play time" video and the skills they are learning. Parents make their way through the 5 core modules sequentially before accessing the supplemental session that may be relevant to them.

GROW Intervention

Eligibility Criteria

• Age: 0 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Does not reside with the caregiver at least half-time
• The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
• English is not the primary language spoken in the home
• Families of children who are non-responsive or in a persistent vegetative state will also be excluded
• Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Maggard BL, Gies LM, Sidol CA, Moscato EL, Schmidt M, Landry SH, Makoroff KL, Rhine TD, Wade SL. Online Intervention for Caregivers of Children with Early Traumatic Brain Injury: Pilot Trial. J Pediatr Psychol. 2023 Mar 20;48(3):205-215. doi: 10.1093/jpepsy/jsac080.

  PMID: 36240452 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: December 16, 2021
• Study Start: September 30, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 21, 2022

Record last verified: 2021-09

Locations

US (1)