TbiNCT02368366
Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
A study testing Therapist Guided Face to Face Family Problem Solving, Therapist Guided Online Family Problem Solving and Self-Guided Online Family Problem Solving in people with Tbi and Intracranial Edema, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
Trial summary
Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Tbi, Intracranial Edema, Brain Edema
- What is being tested?
- Therapist Guided Face to Face Family Problem Solving, Therapist Guided Online Family Problem Solving and Self-Guided Online Family Problem Solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Moderate to severe TBI
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Who cannot join
- Child does not live with parents or guardian
- Child or parent has history of hospitalization for psychiatric problem
- Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
- Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Case Western Reserve University
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Children's Hospital
Denver, Colorado, 80045
About this study
Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction. The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST.
Read the detailed description
Background: Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction.
Methods: The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST. The efficacy of face-to-face and online F-PST in reducing behavior problems following TBI has been established. However, their comparative acceptability and effectiveness are unknown and it is unclear if families could also benefit from online F-PST without therapist support. To identify which patients benefit most from each intervention, participants will be stratified by distance from the clinic with patients living more than 20 miles or 60 minutes from the clinic randomized to one of the two online arms and others equally randomized among three arms. Patient-reported outcomes pertaining to child, caregiver, and family functioning along with patient treatment preferences will be assessed: prior to treatment initiation, at treatment completion, and at a follow-up 3 months later. Stakeholder input (adolescents with TBI and their caregivers) will guide measurement selection and refinements to the treatment protocols. Each treatment modality consists of 10-14 sessions addressing TBI education, problem-solving, self-regulation, and family communication, but varies in the nature and extent of therapist involvement. Participants will include families of 120 adolescents age 14-18 recruited from four metropolitan TBI centers. Mixed models analyses will be used to examine group differences in improvements in child behavior/functioning, caregiver distress, and family burden. Moderators of comparative effectiveness including socioeconomic status, prior technology use, and patient preferences will be examined.
Anticipated Impact: Results will elucidate the relative effectiveness of face-to-face versus online and self-directed versus therapist-supported online modes of treatment including patient and family preferences. They will also provide information about how these programs can be delivered and disseminated through existing head injury follow-up clinics. These data could potentially be translated to other patient populations of youth with psychological symptoms arising from neurological conditions.
- Conditions
- Tbi, Intracranial Edema, Brain Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic
- Being tested
- Therapist Guided Face to Face Family Problem Solving, Therapist Guided Online Family Problem Solving, Self-Guided Online Family Problem Solving
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema, Craniocerebral Trauma, Brain Hemorrhage, Traumatic, Hematoma, Subdural, Brain Concussion, Head Injuries, Closed, Hematoma, Epidural, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist Guided Face to Face Family Problem SolvingBehavioural
Families assigned to this arm will meet with the therapist in person at the medical center TBI clinic. Sessions will last approximately 60 minutes and cover didactic content using printed handouts provided as part of a family workbook.
Therapist Guided Online Family Problem SolvingBehavioural
Families assigned to this arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. Each session of online F-PST consists of a self-guided online portion providing didactic content regarding the desired skill (i.e., problem-solving), video clips showing individuals and families modeling the skill, and exercises and assignments giving the family an opportunity to practice the skill. During synchronous, videoconference sessions with the therapist, the family will review the online materials and practice the problem-solving process.
Self-Guided Online Family Problem SolvingBehavioural
Families in the self-guided, online F-PST arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. They will receive access to the same web-modules as the therapist-guided group, but will review them on their own without therapist support. Participants in this group will be encouraged to complete web modules at the same schedule as participants in the other groups. If the family fails to log on or complete web modules, they will receive reminders via phone, text, or e-mail.
| Study group | Role | What they receive |
|---|---|---|
| Therapist Guided Face to Face FPST | Experimental | Therapist Guided Face to Face Family Problem Solving Families assigned to this arm will meet with the therapist in person at the medical center TBI clinic. Sessions will last approximately 60 minutes and cover didactic content using printed handouts provided as part of a family workbook. Receives: Behavioral: Therapist Guided Face to Face Family Problem Solving |
| Therapist Guided Online FPST | Experimental | Therapist Guided Online Family Problem Solving Families assigned to this arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. Each session of online F-PST consists of a self-guided online portion providing didactic content regarding the desired skill (i.e., problem-solving), video clips showing individuals and families modeling the skill, and exercises and assignments giving the family an opportunity to practice the skill. During synchronous, videoconference sessions with the therapist, the family will review the online materials and practice the problem-solving process. Receives: Behavioral: Therapist Guided Online Family Problem Solving |
| Self-Guided Online FPST | Experimental | Self-Guided Online Family Problem Solving Families in the self-guided, online F-PST arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. They will receive access to the same web-modules as the therapist-guided group, but will review them on their own without therapist support. Participants in this group will be encouraged to complete web modules at the same schedule as participants in the other groups. If the family fails to log on or complete web modules, they will receive reminders via phone, text, or e-mail. Receives: Behavioral: Self-Guided Online Family Problem Solving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Function (BRIEF)
Measured: Baseline, post-intervention and 3 months post-intervention
Secondary outcomes (6)
Center for Epidemiology Scale for Depression (CES-D)
Measured: Baseline, post-intervention and 3 months post-intervention
Health and Behavior Inventory (HBI)
Measured: Baseline, post-intervention and 3 months post-intervention
Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
Measured: Baseline
Brief Symptom Inventory (BSI)
Measured: Baseline, post-intervention and 3 months post-intervention
Strengths and Difficulties Questionnaire (SDQ)
Measured: Baseline, post-intervention and 3 months post-intervention
Pediatric Quality of Life Inventory (PedsQL)
Measured: Baseline, post-intervention and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TbiStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Children's Hospital Colorado, MetroHealth Medical Center, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Shari Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368366
- Sponsor's protocol ID
- CER-1306-02435
- Status last verified
- Jan 2018
- First submitted
- 27 Oct 2014
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wade SL, Cassedy AE, Taylor HG, McNally KA, Kirkwood MW, Stancin T, Horn PS, Kurowski BG. Adolescent quality of life following family problem-solving treatment for brain injury. J Consult Clin Psychol. 2019 Nov;87(11):1043-1055. doi: 10.1037/ccp0000440. Epub 2019 Sep 26.
PubMed 31556652
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
- ClinicalTrials.gov ID
- NCT02368366
- Acronym / sponsor ID
- CER-1306-02435
- Conditions
- Tbi, Intracranial Edema, Brain Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Children's Hospital Colorado, MetroHealth Medical Center, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction. The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST.
Detailed description
Background: Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction.
Methods: The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST. The efficacy of face-to-face and online F-PST in reducing behavior problems following TBI has been established. However, their comparative acceptability and effectiveness are unknown and it is unclear if families could also benefit from online F-PST without therapist support. To identify which patients benefit most from each intervention, participants will be stratified by distance from the clinic with patients living more than 20 miles or 60 minutes from the clinic randomized to one of the two online arms and others equally randomized among three arms. Patient-reported outcomes pertaining to child, caregiver, and family functioning along with patient treatment preferences will be assessed: prior to treatment initiation, at treatment completion, and at a follow-up 3 months later. Stakeholder input (adolescents with TBI and their caregivers) will guide measurement selection and refinements to the treatment protocols. Each treatment modality consists of 10-14 sessions addressing TBI education, problem-solving, self-regulation, and family communication, but varies in the nature and extent of therapist involvement. Participants will include families of 120 adolescents age 14-18 recruited from four metropolitan TBI centers. Mixed models analyses will be used to examine group differences in improvements in child behavior/functioning, caregiver distress, and family burden. Moderators of comparative effectiveness including socioeconomic status, prior technology use, and patient preferences will be examined.
Anticipated Impact: Results will elucidate the relative effectiveness of face-to-face versus online and self-directed versus therapist-supported online modes of treatment including patient and family preferences. They will also provide information about how these programs can be delivered and disseminated through existing head injury follow-up clinics. These data could potentially be translated to other patient populations of youth with psychological symptoms arising from neurological conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapist Guided Face to Face FPST | Experimental | Behavioral: Therapist Guided Face to Face Family Problem SolvingTherapist Guided Face to Face Family Problem Solving Families assigned to this arm will meet with the therapist in person at the medical center TBI clinic. Sessions will last approximately 60 minutes and cover didactic content using printed handouts provided as part of a family workbook. |
| Therapist Guided Online FPST | Experimental | Behavioral: Therapist Guided Online Family Problem SolvingTherapist Guided Online Family Problem Solving Families assigned to this arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. Each session of online F-PST consists of a self-guided online portion providing didactic content regarding the desired skill (i.e., problem-solving), video clips showing individuals and families modeling the skill, and exercises and assignments giving the family an opportunity to practice the skill. During synchronous, videoconference sessions with the therapist, the family will review the online materials and practice the problem-solving process. |
| Self-Guided Online FPST | Experimental | Behavioral: Self-Guided Online Family Problem SolvingSelf-Guided Online Family Problem Solving Families in the self-guided, online F-PST arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. They will receive access to the same web-modules as the therapist-guided group, but will review them on their own without therapist support. Participants in this group will be encouraged to complete web modules at the same schedule as participants in the other groups. If the family fails to log on or complete web modules, they will receive reminders via phone, text, or e-mail. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Moderate to severe TBI
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Key exclusion criteria (4 listed)
- Child does not live with parents or guardian
- Child or parent has history of hospitalization for psychiatric problem
- Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
- Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist Guided Face to Face Family Problem SolvingFamilies assigned to this arm will meet with the therapist in person at the medical center TBI clinic. Sessions will last approximately 60 minutes and cover didactic content using printed handouts provided as part of a family workbook. | Behavioural | Therapist Guided Face to Face FPST |
| Therapist Guided Online Family Problem SolvingFamilies assigned to this arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. Each session of online F-PST consists of a self-guided online portion providing didactic content regarding the desired skill (i.e., problem-solving), video clips showing individuals and families modeling the skill, and exercises and assignments giving the family an opportunity to practice the skill. During synchronous, videoconference sessions with the therapist, the family will review the online materials and practice the problem-solving process. | Behavioural | Therapist Guided Online FPST |
| Self-Guided Online Family Problem SolvingFamilies in the self-guided, online F-PST arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. They will receive access to the same web-modules as the therapist-guided group, but will review them on their own without therapist support. Participants in this group will be encouraged to complete web modules at the same schedule as participants in the other groups. If the family fails to log on or complete web modules, they will receive reminders via phone, text, or e-mail. | Behavioural | Self-Guided Online FPST |
Primary outcome
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline, post-intervention and 3 months post-intervention
6 secondary outcomes
Center for Epidemiology Scale for Depression (CES-D)
Time frame: Baseline, post-intervention and 3 months post-intervention
Health and Behavior Inventory (HBI)
Time frame: Baseline, post-intervention and 3 months post-intervention
Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
Time frame: Baseline
Brief Symptom Inventory (BSI)
Time frame: Baseline, post-intervention and 3 months post-intervention
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, post-intervention and 3 months post-intervention
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline, post-intervention and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Derived from this study: PubMed 31556652Wade SL, Cassedy AE, Taylor HG, McNally KA, Kirkwood MW, Stancin T, Horn PS, Kurowski BG. Adolescent quality of life following family problem-solving treatment for brain injury. J Consult Clin Psychol. 2019 Nov;87(11):1043-1055. doi: 10.1037/ccp0000440. Epub 2019 Sep 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari Wade, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist Guided Face to Face Family Problem Solving, Therapist Guided Online Family Problem Solving and Self-Guided Online Family Problem Solving in people with Tbi and Intracranial Edema, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Function (BRIEF) (time frame: Baseline, post-intervention and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.