- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160194
Gaining Real-Life Skills Over the Web (GROW)
March 7, 2022 updated by: Children's Hospital Medical Center, Cincinnati
Gaining Real-Life Skills Over the Web (GROW)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 4 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: GROW Intervention
Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiologic Studies Depression(CES-D) Scale Change
Time Frame: Pre-Intervention and Immediately Post-Intervention
|
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.
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Pre-Intervention and Immediately Post-Intervention
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Parenting Stress Index (PSI) Change
Time Frame: Pre-Intervention and Immediately Post-Intervention
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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.
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Pre-Intervention and Immediately Post-Intervention
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Patient-Reported Outcomes Measurement Information System Change
Time Frame: Pre-Intervention and Immediately Post-Intervention
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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.
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Pre-Intervention and Immediately Post-Intervention
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Family Burden of Injury Interview (FBII) Change
Time Frame: Pre-Intervention and Immediately Post-Intervention
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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.
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Pre-Intervention and Immediately Post-Intervention
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MacArthur-Bates Communicative Development Inventories (MB-CDI) Change
Time Frame: Pre-Intervention and Immediately Post-Intervention
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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.
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Pre-Intervention and Immediately Post-Intervention
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Caregiver-Child Observation Change
Time Frame: Pre-Intervention and Immediately Post-Intervention
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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.
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Pre-Intervention and Immediately Post-Intervention
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GROW Satisfaction Survey
Time Frame: Immediately Post-Intervention
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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.
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Immediately Post-Intervention
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Background & Family Information Form
Time Frame: Pre-Intervention
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Demographics rehabilitation services
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Pre-Intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2017
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
August 30, 2021
First Submitted That Met QC Criteria
December 3, 2021
First Posted (Actual)
December 16, 2021
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90IFDV0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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