1. What were the results from the original PCORI study?
Among adolescents recovering from traumatic brain injuries (TBI), we compared the effectiveness of three approaches to delivering family problem-solving therapy (F-PST) to improve child behavior, child quality of life, and parent depression. Families of adolescents ages 14-19 who were hospitalized for a moderate to severe TBI and currently experiencing behavior problems were randomly assigned to: 1) face-to-face F-PST, 2) online therapist-guided F-PST, or 3) online self-guided F-PST. In all three treatment groups, families received 10 sessions providing education about the consequences of TBI and training in staying positive, problem-solving, self-regulation, and communication skills. Parents in all three groups reported statistically and clinically significant improvements in their child’s behavior and quality of life. Our study found that the inexpensive and easy to administer self-guided F-PST is as effective as receiving F-PST delivered by a therapist in an office; this could help the many children and families with TBI who currently do not have access to trained therapists. There are very few therapists trained in F-PST for TBI, leaving many families to deal with behavior problems without help. Since some families lack internet access or prefer face-to-face treatment, we will implement all three arms with minor adaptations giving all families access to the website and allowing them to contact a therapist with questions if necessary.
2. Why is this research finding important?
More than 150,000 children in the US experience persistent impairment due to TBI, with tens of thousands going
untreated. Given links between pediatric TBI and academic failure and increased risk of criminal offending, connecting children with evidence-based behavioral treatment is critically important. Our original PCORI study extended previous research by contrasting the innovative therapist-guided online F-PST (also known as telehealth) to the current standard of care (face-to-face therapy) and a less resource and cost-intensive option of online F-PST without therapist involvement. Our findings are noteworthy in that they continue to provide support for the therapist-guided online F-PST program while indicating that many adolescents and families may substantially benefit from accessing the same treatment independently, without therapist involvement. Given the dearth of interventions and lack of knowledgeable community providers to diagnose and treat problems in children with TBI, implementation of the self-guided online FPST through children’s hospitals and rehabilitation facilities has the potential to substantially increase access to care, reduce behavioral challenges, and improve quality of life.
3. What is the goal of this implementation project?
Our overarching objective is to facilitate the implementation of family choice F-PST (all three arms) in real-world practice at 10 children’s hospitals and rehabilitation facilities. Our efforts, guided by advisory panels of patients and families, clinicians, hospital administrators, third-party payers, and community advocacy groups, will address the following aims:
- Implement family choice F-PST into clinical practice at 10 children’s hospitals and rehabilitation centers and measure impact on patient/parent-reported adolescent behavior problems and quality of life
- Identify patient, therapist, health system, and community factors that facilitate or impede implementation or efficacy of family choice F-PST
- Evaluate maintenance of family choice F-PST by sites after 18 months.
4. What is the project team doing?
Using methods grounded in the RE-AIM Framework, we will implement family choice F-PST at 10 children’s hospitals and rehabilitation facilities across the country. We will educate care providers to identify and refer children ages 13-19 who are experiencing behavioral challenges following TBI to family choice F-PST. We will train 55 therapists to deliver F-PST, and certify trainers at each site who can use our online training program and manuals to train additional therapists. We plan to reach more than 400 families through the proposed project. Using methods grounded in the Model for Improvement and successfully employed in multiple multisite implementation projects by Cincinnati Children’s, we have set a shared implementation goal (20% increase in children with TBI receiving behavioral care) and will use monthly teleconferences, transparency on data, and senior leader commitment to implement family choice FPST at all sites. Monthly teleconferences will focus on discussion of pooled data from all sites on reach, efficacy, adoption, implementation, and maintenance and sharing strategies for implementation (“all teach all learn”). Improved health care and outcomes include increased capacity to recognize behavioral challenges following TBI, increased linkage of children to services, and increased capacity to effectively treat and manage TBI-related behavior problems.
5. How is the team evaluating this project?
We will track number of therapists trained and numbers of patients screened, referred, and receiving treatment as indices of reach. To assess fidelity, we will ask therapists to complete five-item post-session fidelity checklists and participate in monthly supervision calls. Data from the F-PST website will provide information regarding the time spent by families on modules. As part of Aim 2, we will identify patient, therapist, health system, and community factors that influence implementation and efficacy. We will use descriptive statistics to understand implementation and efficacy, stratifying by patient, therapist, health system, and community factors. We will evaluate impact on patients and families by examining satisfaction and improvements in key parent-reported outcomes (child behavior problems, child quality of life, parental depression). We will evaluate maintenance of implementation for six months after supports are withdrawn.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
We have included key stakeholders in all phases of this project. Jessica Aguilar, PhD, a survivor of a severe TBI in adolescence, is a co-investigator. Patients, families, medical providers, and therapists have informed proposal development and will guided implementation (through both qualitative interviews about their experiences with F-PST and through discussions in planning for the study). To ensure maintenance and scalability, we have engaged key regional and state organizations that provide information and referrals to families, and will engage state psychology boards and third-party payers.
7. How will this project help ensure future uptake and use of PCORI results?
We will develop a sustainability plan with each site to ensure that the infrastructure and processes from this PCORI-funded project remain part of day to day operations in each hospital after funding ends. On-site certified trainers and a training webinar will ensure ongoing training of additional therapists over time. Participating hospitals are national leaders, exerting influence in standard of care. These hospitals are also members in local, state, regional and national networks which offer opportunities for national scale.
Related PCORI-funded Research Project
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.