Results Summary
What was the research about?
Violent bumps or blows to the head can cause traumatic brain injury, or TBI. Teens may develop TBI from accidents or sports injuries. People with TBI often have headaches, nausea, dizziness, confusion, and mood changes. Some TBIs cause physical, emotional, and behavioral problems that may last a long time and that may be stressful for families. Family problem-solving therapy, or F-PST, teaches skills to help families communicate, manage anger, and adjust to changes in daily life.
In this study, the research team wanted to learn if online F-PST was similar to in-person F-PST in reducing the effects of TBI for teens and their parents. The team compared three ways of offering F-PST to teens and their parents:
- Online F-PST with a therapist: hour-long video calls with a therapist and online materials, including videos and ways to practice skills learned during the calls
- Online F-PST without a therapist: access to online materials that teens and parents could go through on their own; this group didn’t meet with a therapist
- In-person F-PST: hour-long meetings with a therapist at a hospital or clinic and printed materials
What were the results?
In this study, the online and in-person F-PST options had similar results for teens and their parents. Comparing the different ways of offering F-PST, the teens in the three groups didn’t differ in
- Behaviors, such as mood swings or outbursts of anger
- Ability to get things done
- Quality of life
- TBI symptoms
- Depression
The study found no difference in parents’ depression or ability to deal with stress.
Who was in the study?
The study included 150 teens ages 14 to 19, treated at one of five TBI centers in Ohio and Colorado, and their parents. All teens had mild to severe TBI with lasting changes in behavior. Of these teens, 83 percent were white, 11 percent were African American, and 7 percent were another race or more than one race; 4 percent were Hispanic. The average age was 16, and 64 percent were teenage boys.
What did the research team do?
The research team assigned teens and their parents, by chance, to get F-PST in one of the three ways. In each approach, families could attend up to 10 sessions about staying positive, solving problems, and controlling emotions. The team offered up to four more sessions on topics such as how to handle a crisis.
Teens and their parents filled out surveys at the start of the study and again six and nine months later. Surveys asked about teens’ behaviors and ability to get things done. Surveys also included questions about quality of life, depression, and TBI symptoms.
Doctors, teens with TBI and their parents, and a web designer helped design and carry out the study.
What were the limits of the study?
After six months, 19 percent of teens and parents hadn’t completed treatment. The number of people who didn’t finish treatment was about the same in each group. On average, families completed only six sessions. Results might have been different if families attended more sessions. Problems with the website and with video calls may have kept teens and parents from viewing programs online or attending online therapy sessions.
Future research could test ways to help more people attend more sessions.
How can people use the results?
Doctors, teens with TBI, and their parents can use these results when considering different options for therapy.
Professional Abstract
Objective
To compare the effectiveness of online family problem-solving therapy (F-PST), either self-guided or therapist guided, versus traditional in-person F-PST for adolescents with traumatic brain injury (TBI) and their parents in improving adolescents’ behaviors and functioning
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 150 adolescents ages 14–19 with complicated mild to severe TBI and their parents |
| Interventions/ Comparators |
|
| Outcomes |
Primary: adolescents’ self-reported and parent-reported behaviors and executive functions, defined as behavior regulation and ability to stay on task Secondary: adolescents’ self-reported quality of life; self-reported adolescent and parent depression; adolescents’ self-reported and parent-reported cognitive, somatic, emotional, and behavioral symptoms of TBI; self-reported parental distress |
| Timeframe | 9-month follow-up for primary outcomes |
This randomized controlled trial compared three approaches to providing F-PST to adolescents with TBI and their parents. F-PST for TBI aims to build skills to improve the family's ability to cope with stress after TBI.
The research team randomly assigned adolescents and their parents to one of three treatment groups:
- Therapist-guided online F-PST. Adolescents and parents attended hour-long videoconference sessions with a therapist and viewed modules online, including videos and exercises for families to practice skills learned during the sessions.
- Self-guided online F-PST. Adolescents and parents accessed the same modules provided to the other online group, but without a therapist. At baseline, adolescents and parents scheduled dates to complete modules. They received reminders if they did not complete modules by their goal dates.
- Therapist-guided in-person F-PST. Adolescents and parents discussed their concerns about TBI during hour-long meetings with a therapist at a hospital or outpatient clinic and received written modules.
In each study group, the research team offered participants 10 family sessions about staying positive, solving problems, communicating, and managing anger. Sessions were weekly for the first month and then biweekly for the next three months. The team offered participants four supplemental sessions to address other concerns, such as marital communication, help for siblings, and crisis management.
The study included 150 adolescents ages 14 to 19 with complicated mild to severe TBI and persistent behavioral symptoms, treated at one of five TBI centers in Ohio and Colorado, and their parents. Of these adolescents, 83% were white, 11% were African American, and 7% were another race or more than one race; 4% were Hispanic. The average age was 16, and 64% were male.
The research team collected assessments in person at baseline and again at six and nine months after the study started.
Clinicians, adolescents with TBI and their parents, and a web designer worked with the research team on the content and development of the interventions.
Results
Overall, the three study groups did not differ significantly in adolescents’ executive function, behaviors, quality of life, depression, and TBI symptoms or in parental depression and distress.
Limitations
At six months, 19% of participants had not completed treatment; attrition did not differ significantly by group. Across treatment groups, the mean number of sessions attended was about six, which was below the intended number of 10 to 14 sessions. Technical difficulties with the website and videoconferencing may have interfered with participants’ abilities to view modules or attend therapy sessions online. Results might have differed with higher adherence or if participants had attended more sessions.
Conclusions and Relevance
This study found no difference among groups receiving F-PST online versus in person, suggesting that in-person therapist involvement may not be necessary for some adolescents with TBI and their families. However, the low adherence rate to F-PST across groups in this study makes this conclusion uncertain.
Future Research Needs
Future research could find ways to improve adherence to family therapy, whether online or in person, in all study groups.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers questioned whether study participants received the same level of therapist involvement in the face-to-face and the therapist-guided online delivery of family problem solving treatment. The researchers confirmed that participants spent an equivalent amount of time in both delivery conditions with the therapist, reviewing content and developing plans to address their problems. The researchers revised the report to clarify this fact.
- Reviewers asked for additional substantiation for the criterion that attendance at 3 or more sessions out of 10-14 in the face-to-face condition constituted program participation. The researchers explained that three sessions were sufficient for the family to receive training in cognitive reframing and problem-solving skills, the focus of the treatment. As additional confirmation, the researchers ran their analysis model with sessions completed as a continuous variable and found no significant differences based on the number of sessions completed.
- Reviewers asked that the report better address how the researchers handled missing data in analyses. The researchers revised the analytical and statistical approaches portion of the methods section to explain that when they examined the utility of multiple imputation to account for missing data, they found minimal differences between the models with and without multiple imputation for the primary outcomes. Given that multiple imputation on repeated measures of outcomes fails to capture time-specific orderings also, the researchers used mixed models without imputation.
- Reviewers asked how the researchers determined that the effect size of 0.5 indicated a minimally clinically important difference (MCID) for the primary outcomes. The researchers explained the 0.5 was equivalent to half a standard deviation change on the primary outcome measures, which is the MCID seen in many clinical studies.