Long-term benefits of an early online problem-solving intervention for executive dysfunction after traumatic brain injury in children: a randomized clinical trial

Abstract

Importance: Executive dysfunction after traumatic brain injury (TBI) in children is common and leads to significant short- and long-term problems in functioning across multiple settings. We hypothesized that improvements in short-term executive function would be maintained to 24 months after injury and that improvements would increase over time in a counselor-assisted problem-solving (CAPS) intervention.

Objective: To evaluate the efficacy of a CAPS intervention administered within 7 months of complicated mild to severe TBI compared with an Internet resource condition in improving long-term executive dysfunction.

Design, setting, and participants: Multisite, assessor-blinded, randomized clinical trial at 3 tertiary pediatric hospitals and 2 tertiary general medical centers. Participants included 132 adolescents aged 12 to 17 years who sustained a moderate to severe TBI 1 to 7 months before study enrollment.

Intervention: Web-based CAPS intervention.

Main outcomes and measures: The primary outcome was the parent-reported Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function. Secondary outcomes included the Behavioral Regulation Index (BRI) and Metacognition Index (MI) of the GEC.

Results: In older (>14 to 17 years) adolescents, the CAPS intervention was associated with lower GEC ratings at 12 (β = -0.46; P = .03) and 18 (β = -0.52; P = .02) months after enrollment. Trends were also observed for older adolescents toward lower GEC ratings at 6 months (β = -0.40; P = .05), lower BRI ratings at 12 (β = -0.40; P = .06) and 18 (β = -0.47; P = .04) months, and lower MI ratings at 6 (β = -0.41; P = .05), 12 (β = -0.46; P = .03), and 18 (β = -0.50; P = .03) months. In younger (12-14 years) adolescents, no group differences were found on the GEC, BRI, or MI ratings.

Conclusions and relevance: Delivery of the CAPS intervention early after TBI in older adolescents improves long-term executive function. This trial is, to our knowledge, one of the few large, randomized clinical treatment trials performed in pediatric TBI to demonstrate the efficacy of an intervention for management of executive dysfunction and long-term benefits of an intervention delivered soon after injury. Use of the CAPS intervention clinically should be considered; however, further research should explore ways to optimize delivery.

Trial registration: clinicaltrials.gov Identifier: NCT00409448.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1. CONSORT Flow Diagram

Patients were randomized to the counselor-assisted problem-solving (CAPS) intervention or an Internet resource condition (IRC). Patients unavailable for follow-up could not be contacted.

Figure 2. Study Timeline

CAPS indicates counselor-assisted problem-solving; IRC, Internet resource condition.

Figure 3. Mixed-Model Contrasts of the Counselor-Assisted Problem-Solving (CAPS) vs Internet Resource Condition (IRC) Groups Stratified by Age With Global Executive Composite (GEC) as the Dependent Variable

Within the younger group (aged 12–14 years), no differences between the CAPS and IRC groups were seen at baseline (β = −0.15; P = .53) or at 6 (β = −0.23; P = .8), 12 (β = 0.04; P = .88), or 18 (β = 0.13; P = .62) months after the intervention. Within the older group (aged >14 to 17 years), no differences were seen at baseline between the CAPS and IRC groups (β = −0.34; P = .11) but were seen at 6 (β = −0.40; P = .05), 12 (β = −0.46; P = .03), and 18 (β = −0.52; P = .02) months after the intervention. Error bars represent SE.

Figure 4. Mixed-Model Contrasts of the Counselor-Assisted Problem-Solving (CAPS) vs Internet Resource Condition (IRC) Groups Stratified by Age With Global Executive Composite (GEC) Subscales as Dependent Variables

A, Behavioral Regulation Index (BRI) subscale of the GEC. B, Metacognition Index (MI) subscale of the GEC. Within the younger group (aged 12–14 years), no differences were seen between the CAPS and IRC groups at baseline (β = 0.03; P = .91) or 6 (β = −0.11; P = .63), 12 (β = 0.20; P = .41), or 18 (β = 0.29; P = .28) months after the intervention on the BRI or at baseline (β = −0.28; P = .27) or 6 (β = −0.16; P = .68), 12 (β = −0.05; P = .84), or 18 (β = 0.07; P = .8) months on the MI. Within the older group (aged >14 to 17 years), no differences were seen between the CAPS and IRC groups at baseline (β = −0.25; P = .24) or 6 months after the intervention (β = −0.32; P = .11) on the BRI or at baseline (β = −0.36; P = .09) on the MI. We found a trend for improvement in the CAPS group at 12 (β = −0.40; P = .06) and 18 (β = −0.47; P = .04) months after the intervention on the BRI and at 6 (β = −0.41; P = .05), 12 (β = −0.46; P = .03), and 18 (β = −0.50; P = .03) months on the MI. Error bars represent SE.