Effects of an individualized and goal-oriented intervention in the chronic phase of pediatric acquired brain injury: the Child in Context Intervention (CICI)—a randomized controlled trial

BACKGROUND: The objective was to investigate the effect of an individualized, goal-oriented intervention for children in the chronic phase of pediatric acquired brain injury (pABI). METHODS: A randomized controlled trial (RCT) of the Child in Context Intervention (CICI) with a 1:1 randomization to an intervention or treatment as usual control group. Children (6-16 years) with pABI ≥ 1 year before recruitment and pABI-related challenges in daily life were included with their parents and assessed at time point 1 (T1) and again after 6 months (T2) and 9 months (T3). The manualized rehabilitation intervention lasted 5 months and contained seven family sessions, four school sessions, and a parent seminar. Outcome assessors were blinded to group allocation. Preestablished primary outcomes were parent-reported brain injury symptoms in the children (Health and Behavior Inventory; HBI) and parenting self-efficacy (Tool to measure Parenting Self-efficacy; TOPSE/Teen TOPSE). Secondary outcomes assessed unmet health care needs, parental mental health, family functioning, quality of life, executive functioning, and severity of pABI-related main challenges in daily life. RESULTS: Fifty-eight children (30 boys) and 112 parents (53 fathers) participated. The median age of the children at T1 was 11.7 (range 6.3 -16.9) years. No significant mean between group effect was found from T1 to T3 on the primary outcomes. Significant mean between group effects in favor of the intervention group were found regarding unmet health care needs (FNQ-P: 0.42; 95% CI 0.15 to 0.69; p = .002), parental symptoms of anxiety (GAD-7: -1.83; 95% CI -3.32 to -0.35; p = .016) and depression (PHQ-9: -2.0; 95% CI -3.69 to -0.30; p = .021), and family functioning (FAD-GF: -0.20; 95% CI -0.32 to -0.07; p = .002) at the main end-point T3. CONCLUSIONS: Acknowledging that the success of an intervention is defined by interpretation of all available evidence, not just the primary outcome(s), results indicate that the CICI is effective and can help families in the chronic phase after pABI. This is the first RCT to our knowledge that offers an individualized and goal-oriented pABI-intervention to children in the chronic phase, while involving families and schools. TRIAL REGISTRATION: ClinicalTrials.gov NCT04798859, 2021-05-10 https://clinicaltrials.gov/study/NCT04798859?term=Child%20in%20Context%20Intervention&rank=1.