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Gaining Real-Life Skills Over the Web (GROW)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Parenting Intervention
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Parent-Child Relations, Parenting

Eligibility Criteria

0 Years - 4 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GROW Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Background & Family Information Form
Demographics rehabilitation services

Secondary Outcome Measures

Full Information

First Posted
August 30, 2021
Last Updated
March 7, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT05160194
Brief Title
Gaining Real-Life Skills Over the Web
Acronym
GROW
Official Title
Gaining Real-Life Skills Over the Web (GROW)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Parent-Child Relations, Parenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROW Intervention
Arm Type
Other
Arm Description
Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Positive Parenting Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression(CES-D) Scale Change
Description
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.
Time Frame
Pre-Intervention and Immediately Post-Intervention
Title
Parenting Stress Index (PSI) Change
Description
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.
Time Frame
Pre-Intervention and Immediately Post-Intervention
Title
Patient-Reported Outcomes Measurement Information System Change
Description
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.
Time Frame
Pre-Intervention and Immediately Post-Intervention
Title
Family Burden of Injury Interview (FBII) Change
Description
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.
Time Frame
Pre-Intervention and Immediately Post-Intervention
Title
MacArthur-Bates Communicative Development Inventories (MB-CDI) Change
Description
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.
Time Frame
Pre-Intervention and Immediately Post-Intervention
Title
Caregiver-Child Observation Change
Description
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.
Time Frame
Pre-Intervention and Immediately Post-Intervention
Title
GROW Satisfaction Survey
Description
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.
Time Frame
Immediately Post-Intervention
Title
Background & Family Information Form
Description
Demographics rehabilitation services
Time Frame
Pre-Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36240452
Citation
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.
Results Reference
derived

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Gaining Real-Life Skills Over the Web

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