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Original Articles

Online Family Problem-Solving Therapy (F-PST) for Executive and Behavioral Dysfunction After Traumatic Brain Injury in Adolescents

A Randomized, Multicenter, Comparative Effectiveness Clinical Trial

Kurowski, Brad G. MD, MS; Taylor, H. Gerry PhD; McNally, Kelly A. PhD; Kirkwood, Michael W. PhD; Cassedy, Amy PhD; Horn, Paul S. PhD; Stancin, Terry PhD; Wade, Shari L. PhD

Editor(s): Caplan, Bruce PhD, ABPP; Bogner, Jennifer PhD, ABPP; Brenner, Lisa PhD, ABPP; Malec, James PhD, ABPP

Author Information
Journal of Head Trauma Rehabilitation: May/June 2020 - Volume 35 - Issue 3 - p 165-174
doi: 10.1097/HTR.0000000000000545
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Abstract

TRAUMATIC BRAIN INJURY (TBI) is a worldwide health problem, one of the most common causes of acquired disability in youth and a source of significant morbidity and family burden.1–7 TBI results in 7843 deaths, 46 260 hospitalizations, and 1 083 122 emergency department visits in children and young adults yearly in the United States.6 Early injuries can have a life-long impact.8 TBI often results in deficits in cognition, behavior, and social development.9–11 Emerging behavior problems are common,12–14 yet many youth fail to receive treatment due to lack of identification and access.15,16 Linking youth with TBI to effective treatments could improve functional outcomes and reduce family burden.

Online family problem-solving therapy (F-PST) with therapist involvement has demonstrated efficacy in improving behavioral problems after pediatric TBI. F-PST, involving the adolescent with TBI, one or both parents and siblings when available, targets family-level problems with effective communication and problem-solving while providing the individual with TBI with an executive function heuristic for addressing deficits in inhibition (stop and think) and self-regulation.17 Results from 5 previous randomized controlled trials suggest that older children as well as those from families of lower socioeconomic status or with higher levels of behavior problems prior to treatment are more likely to have improved behavior and executive function relative to those who were assigned to receive access to online TBI resources only.17 Although some improvements were apparent immediately following treatment, other effects did not emerge for a full year.18

While these findings highlight the potential utility of online, therapist-guided F-PST for post-TBI behavior problems, they pose additional questions regarding how this treatment approach (online with therapist involvement) compares to traditional face-to-face or online treatment without therapist involvement. Electronic health approaches reduce barriers such as distance, time, and cost.19 However, their comparative effectiveness versus traditional face-to-face F-PST has not been tested. Moreover, the value of therapist support for skill implementation also remains untested. Identifying families who benefit from online F-PST without therapist involvement could significantly reduce costs and expand access. Thus, a critical next step is to evaluate the benefits of differing modes of F-PST in a typical clinical setting and to identify who benefits from each delivery mode.

We evaluated the comparative effectiveness of 3 delivery modes of F-PST for improvement of parent-reported executive functions and behavior. We anticipated that participants in all 3 groups would improve from pre- to posttreatment and that these improvements would be maintained at follow-up 3 months later. We were particularly interested in testing for noninferiority of the self-guided group compared with other groups. We further sought to identify moderators of treatment efficacy. Specifically, we hypothesized that individuals with greater social disadvantage (lower education, lower income, and single marital status) would benefit more from the greater intensity of the therapist-guided online intervention, which provided both web-based psychoeducation and synchronous therapy sessions; whereas those with greater resources would report equivalent benefit regardless of modality. We evaluated time since injury and injury severity as additional moderators given evidence that F-PST may be less effective20,21 during the acute recovery period22 and that children with severe TBI may benefit more.23 These primary study outcomes provide critically needed information about the optimal mode for delivery of online F-PST following pediatric TBI.

METHODS

Design

A multicenter, randomized clinical trial design was used to examine the comparative effectiveness of 3 versions of F-PST in improving/ameliorating patient- and caregiver-reported executive dysfunction and behavioral impairment.24 The 3 groups (face-to-face F-PST, therapist-guided online F-PST, and self-guided online F-PST) have equivalent content but vary in delivery mode and the degree of therapist involvement. Families were randomized based on their distance from the hospital. Patients who lived 25 miles or more from the hospital/clinic were randomly assigned to one of the 2 online arms (therapist-guided online F-PST and self-guided online F-PST). Patients who lived less than 25 miles were randomly assigned to 1 of the 3 arms (therapist-guided face-to-face F-PST, therapist-guided online F-PST, and self-guided online F-PST) in a 2-to-1 ratio, with a higher proportion assigned to the face-to-face arm. The study was conducted at 5 level I trauma centers at hospitals affiliated with academic institutions in Ohio and Colorado.

Participants

Participants included families of 150 youth aged 14 to 19 years with complicated, mild to severe TBI who were hospitalized for TBI and had evidence of behavior problems at enrollment. Potentially eligible children were identified based on trauma registry information from the previous 19 years, during an outpatient medical visit, or via referral from their medical providers. Consistent with prior research, severe TBI was defined by a lowest Glasgow Coma Scale (GCS) score of 8 or less and moderate TBI was defined by a GCS score of 9 to 12 or a higher GCS score accompanied by abnormalities on neuroimaging.18,24–26 Exclusionary criteria included primary language other than English, parent psychiatric hospitalization during the past year, or child psychiatric hospitalization prior to their TBI. Children with moderate-to-severe preinjury cognitive disability and those who had not recovered sufficiently to verbally participate were also excluded. We included children with nonblunt trauma or a history of child abuse. Participant enrollment and study participation are detailed in Figure 1 (CONSORT flow diagram).

Figure 1
Figure 1:
CONSORT flow diagram.

Screening assessment

During the recruitment call, research coordinators administered the Impact Scale of the Strengths and Difficulties Questionnaire (SDQ).27 Children rated by parents as having current behavior problems of more than 1-month duration that interfered with functioning “only a little” in 2 or more domains, or “a medium amount” or “a great deal” in at least one domain, were invited to enroll.

Baseline interview and assessment

Baseline assessment measures24 were administered by a research assistant naïve to group assignment either in the medical clinic or the family's home, depending on family preference. Randomization, via sealed envelope, was done after baseline assessments were completed.

Computer installation and orientation

Families without a computer and/or Internet services who were assigned to 1 of the 2 online arms received a tablet and/or Internet access for the program duration.

Interventions

Participants in all 3 treatment arms received 10 sequential core sessions providing training in staying positive/cognitive reframing, problem-solving, communication, and self-regulation/anger management.24 Core sessions were presented in the same order to all participants, with limited flexibility in emergent circumstances. For online participants, the entire family was encouraged to view website and complete the online activities together, and the family logged who participated on the website. Families in the face-to-face group received a family workbook with handouts that corresponded to the online content. Beginning in session 2, the youth with TBI and his/her family were encouraged to apply the problem-solving heuristic to a personal problem or goal at each subsequent session. In the 2 therapist-guided arms, therapists met with families for approximately 60 minutes to review didactic information, practice skills, and problem-solve around family aims. Based on individual family concerns, families in the therapist-guided arms could receive up to 4 additional meetings with the therapist.24 The online therapist- and self-guided arms could view all 11 supplemental sessions online. The face-to-face arm participants could complete up to 4 additional sessions with their therapist, with hand-outs for the additional, supplemental online session content available upon request.

Study therapists all had a PhD in clinical psychology, experience treating pediatric TBI, and training in cognitive behavioral therapy. They completed a 2-day F-PST training prior to delivering the intervention. Treatment was guided by a comprehensive treatment manual outlining session objectives (available on request from the last author). Fidelity was maintained through biweekly supervision calls and postsession fidelity checklists. The same therapist delivered both therapist-directed treatments ensuring good fidelity between the 2 approaches. Reminders of sessions were provided to all groups. To ensure similarity of reminders between the therapist-guided and self-guided groups when session were missed, families in the self-guided group who failed to log on or complete web modules also received reminders via phone, text, or e-mail. Thus, the self-guided online group received the same frequency and types of reminders as the therapist-directed groups.

Outcome measures

Parents and adolescents completed the Behavior Rating Inventory of Executive Function (BRIEF), a rating of the child's executive functioning abilities.27,28 The BRIEF provides a valid assessment of executive function in daily life and has good internal consistency, interrater reliability, and test-retest reliability.27,29–32 The Global Executive Composite (GEC) is an overall index of executive functioning.27,29–32 The Behavior Regulation Index (BRI) assesses the children's ability to shift cognitive set and appropriately modulate their behaviors and emotions.27,29–32 The Metacognition Index (MI) provides a rating of the child's planning, organization, and problem-solving behaviors.27,29–32 Higher scores indicate poorer executive function, and a score of 65 suggests clinical impairment.27,29–32 The SDQ is a parent rating of child behavior.33–35 The 25-item SDQ yields summary scores for Total, Externalizing and Internalizing symptoms. The SDQ has good validity and reliability.34–36 Higher scores are associated with more difficulties, with Total scores of 17 or greater indicating high difficulties.33

A priori sample size and power calculations

Power was calculated based on comparison of change from baseline to 6 months in the 2 online groups.24 Assuming a standard deviation of 7 units in the change scores from baseline to 6 months and a clinically relevant group difference of 5 units,37,38 a sample size of 43 per group was needed for 90% power at α = 0.05. Given our primary interest in the comparative efficacy of the 2 online arms, the study was powered for this comparison.

Analysis

Descriptive statistics were completed to characterize continuous and categorical variables. Parametric and nonparametric comparisons among groups were made when appropriate. To evaluate comparative treatment effects, repeated-measures mixed models were used. The dependent variables were the BRIEF GEC, BRI, and MI and SDQ Total, Internalizing, and Externalizing scores. Covariates included in all models were time since injury at baseline, site, race (Caucasian or not), and visit (ie, baseline, 6-month, or 9-month follow-up).39 The primary independent variables of interest were treatment group and the interaction of treatment group by visit. Within the mixed models, the trajectory of recovery was evaluated within each group. The outcomes were also compared among all 3 groups (face-to-face, online therapist-guided, and self-guided online). To determine individuals most likely to benefit from varying modes of F-PST, we evaluated the influence of parental education, income, marital status, time since injury, and injury severity as potential moderators. All interaction terms among treatment group, visit, and the moderator were included in these models. Post hoc analyses restricted to individuals who completed at least 5 sessions were done to explore whether more optimal treatment adherence analyses yielded similar findings to the intent-to-treat mixed model analysis. Significance was considered if the P value < .05, with effect sizes reported. The effect sizes reported here are derived from the mixed-model results and are similar to Cohen's d (and Hedge's g), with adjusted t-statistics for the pairwise differences.40 All statistical analyses were conducted using SAS statistical software version 9.4 (SAS Institute Inc, Cary, North Carolina).

RESULTS

One-hundred fifty participants provided informed consent, completed a baseline visit, and were randomized (see Figure 1). Of these, 34 were assigned to the face-to-face treatment, 56 to the therapist-guided online treatment, and 60 to self-guided online treatment (see Figure 1). These participants included 96 males with an average age at injury of 11.8 years and an age at enrollment of 16.4 years, 73 of whom had severe TBI and 124 of whom were white (see Table 1). There were no significant differences among treatment groups in demographic and injury characteristics, with the exception that a lower proportion of Caucasians were in the face-to-face group compared with the therapist- and self-guided online groups (see Table 1). Baseline assessments were similar among groups (see Table 1).

TABLE 1
TABLE 1:
Participant characteristics and baseline measuresa

Of the participants randomized, 24 in the face-to-face, 47 in the therapist-guided online, and 53 in the self-guided online received the allocated intervention and completed at least part of the 6 and/or 9-month assessments. A similar (P = .30) mean number of sessions were completed by participants in the face-to-face (7.0, SD = 4.5), therapist-guided online (7.7, SD = 4.3), and self-guided online groups (7.1, SD = 5.0).

Mixed-model analyses of comparative effectiveness failed to reveal differences among treatment groups on the parent- or self-report BRIEF scores or SDQ scales. Additionally, when restricting the analyses to individuals who completed at least 5 sessions, comparative analyses indicated that the groups were similar in their effectiveness.

However, in pairwise comparisons of treatment groups (face-to-face vs therapist-guided online; face-to-face vs self-guided online; and therapist-guided online vs self-guided online) using intent-to-treat mixed models, the self-guided group had better outcomes on the BRIEF MI at 6 months than the face-to-face group (t = 2.11, effect size = 0.59, P = .037), with this difference approaching significance at 9 months (t = 1.94, effect size = 0.51, P = .055).

Within-group analysis (see Table 2) demonstrated benefits of treatment on the parent BRIEF-GEC, MI, and BRI. Benefits on the parent BRIEF-GEC at 6 months were found for the therapist-guided (t = 1.95, effect size = 0.41, P = .053) and self-guided (t = 2.52, effect size = 0.50, P = .013) online groups, with the effects remaining significant and increasing in magnitude at 9 months for only the self-guided online group (t = 4.29, effect size = 0.86, P < .001). Improvement on the parent BRIEF BRI from baseline to 6 months was evident for the therapist and self-guided online groups (therapist-guided: t = 2.56, effect size = 0.53, P = .012; self-guided: t = 2.51, effect size = 0.50, P = .014), with the benefits of the therapist-guided intervention (t = 2.06, effect size = 0.42, P = .042) remaining relatively stable and benefits of the self-guided intervention (t = 3.83, effect size = 0.77, P < .001) increasing at 9 months. Benefits on the parent BRIEF MI were also found for the self-guided group at 9 months (t = 3.67, effect size = 0.73, P < .001). Analysis failed to reveal significant changes for any of the treatment groups on the self-report BRIEF GEC, BRI, or MI at either the 6- or 9-month visit (P all > .05).

TABLE 2
TABLE 2:
Within-group changes in outcomes from baseline to immediate posttreatment visit (6 months) and delayed posttreatment visit (9 months)

Scores for the Self-guided group significantly improved from baseline to 9 months on the SDQ Total (t=3.67, effect size = 0.73, P < .001), Externalizing (t = 3.20, effect size = 0.63, P = .002), and Internalizing (t = 2.85, effect size = 0.56, P = .005) scales. However, there were no significant improvements on these measures from baseline to 6 months or 9 months for the face-to-face or therapist-guided online groups.

Examination of potential moderators of differences in outcomes revealed that only marital status (married vs unmarried) was statistically significant and only for the SDQ Externalizing scale. Post hoc analyses indicated that this moderation effect was driven by differences within the self-guided online group. Specifically, married-caregiver status was associated with significant improvements in externalizing symptoms from baseline to 9 months with corresponding large effect sizes (t = 3.50, effect size = 0.95, P = .001), whereas unmarried participants in this and the other treatment groups did not.

DISCUSSION

This comparative effectiveness study of 3 modes of problem-solving suggests that effectiveness among varying treatment modalities is similar. Both self-guided online and therapist-guided online approaches were associated with improvements in parent-reported executive-function behaviors, with only the self-guided online found to improve on broad-based parent-reported behavior problems. Importantly, we found minimal/no support for the efficacy of the face-to-face approach in improving either parent- or self-reported outcomes. Although evidence of hypothesized moderation effects was limited, being married was associated with a better response to self-guided delivery mode on parent-reported behavioral outcomes, which is consistent with the expectation that families with more resources may benefit more readily from self-directed treatment.41 While confirming previous research supporting the effectiveness of problem-solving therapy for management of executive and behavioral dysfunction in individuals hospitalized with complicated mild to severe TBI,17,37,42 results from this study suggest that the current standard of care (ie, face-to-face intervention) may not be superior to online treatment delivery.

These findings also suggest that the benefits of problem-solving therapy may be equal or greater when families complete treatment independently of a therapist. The lack of significant changes in problem behaviors on the SDQ within the therapist-guided online group needs to be interpreted in the context of differences in the population enrolled and the measure (SDQ vs Child Behavior Checklist) examined in this study compared with prior research.42 Participants in the current study varied more widely in time since injury than in previous studies and included children with abusive head trauma. Additionally, eligibility criteria required parental concern about behavioral functioning. Importantly, the findings underscore the promise of self-guided online F-PST in this vulnerable population with identified behavioral impairments who often fail to receive needed behavioral treatments.

The lack of efficacy in the face-to-face group compared with online groups on these primary outcomes raises important questions regarding how we clinically address behavioral concerns with families following TBI. Despite identical content and providers and a similar number of session completed among groups, there was not significant improvement in the face-to-face arm on either parent- or self-reported executive function or problem behaviors. This may be due in part to differences in the population of those living closest to the participating hospitals (who were disproportionately represented in the face-to-face group). It may also have to do with how content is delivered, with both online treatments allowing participants to digest content at their own pace and review videos or pages as needed. Although the number of sessions completed did not differ significantly among groups, online participants may have had greater exposure due to their ability to review content again as desired. Adolescents are virtually constant consumers of online content and this approach to intervention delivery may more closely dovetail with their learning style and preferred modes of information consumption.43 Coming to the hospital for therapy may have also been associated with memories of the original hospitalization raising the potential for post-traumatic stress symptoms and expectations regarding complete recovery.44 These findings suggest the potential need to optimize how care is delivered to patients and their families and consider greater use of electronic health interventions as a first line of psychosocial care. There is high likelihood that this trend will emerge in adult rehabilitation care as well.45–47

Hypothesized heterogeneity in treatment effects was largely unsupported, specifically families with fewer resources did not benefit more from the therapist-involved treatments. Some families may require additional supports to derive optimal benefits from the self-guided F-PST. The finding of differing perceptions between parents and adolescents regarding improvements is consistent with prior research with this population and evidence that adolescents with TBI may have limited self-awareness of their deficits.23,48–50 In the latter case, improvements in self-awareness may result in ratings of more rather than fewer concerns after treatment.

Study limitations

Due to the randomization scheme that was stratified by distance, the face-to-face group was smaller than the other groups, which may have limited the power to detect differences between it and the other groups. Although assessors at baseline were naïve to group assignment and follow-up assessments were completed online, it was not possible to conceal group assignment from parents or adolescents. Due to the high proportion of individuals from large metropolitan areas in the face-to-face group and overall limited number of families from rural areas in the study, examination of urban versus rural residence as a moderator of treatment effects was precluded. However, a higher proportion of parents indicated that they preferred one of the online treatments prior to group assignment and this may have biased their perceptions of and participation in the face-to-face arm.51 Treatment sessions were not recorded and coded for fidelity; therefore, we are not able to provide more details on fidelity. We selected a briefer assessment (SDQ) of behavior problems in response to stakeholder input. However, it is possible that it was less sensitive to change than the Child Behavior Checklist, which was used in prior studies. Additionally, follow-up was limited to 3 months following treatment completion, precluding our ability to assess lagged effects.

CONCLUSION

This unique comparative effectiveness study supports the utility of both self- and therapist-guided online F-PST in improving executive function behaviors in adolescents who sustained a TBI. They provide exciting new evidence regarding the efficacy of online F-PST without therapist involvement suggesting a potentially fruitful and currently underutilized avenue for addressing behavioral needs in this underserved population. Given the rapidly evolving regulations regarding telehealth or e-health interventions, further work regarding clinical implementation and how best to integrate telehealth with ongoing rehabilitation care is warranted.

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Keywords:

adolescent; executive function; online; therapy; traumatic brain injury

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