NCT03243396.
| Study name | Building and Sustaining Interventions for Children: task‐sharing mental health care in low‐resource settings (BASIC) |
| Methods |
Study design: cluster‐RCT Country: Kenya |
| Participants | Children and adolescents (11 to 14 years) Inclusion criteria: a. child or young adolescent between the ages of 11 and 14 at the time of enrolment; b. child lost one or both parents to death at least 6 months ago or later, and when the child was 4 years old or older; c. lives in the community with at least one adult guardian (18 years old or older); d. experiencing borderline or clinically significant levels of post‐traumatic stress or childhood traumatic grief (as indicated by a score of 18 or higher on the Child Post‐traumatic Stress Scale, or a score of 35 or higher on the Inventory of Complicated Grief). Exclusion criteria: a. known developmental or cognitive disability; b. attends private school; c. child and family are about to move; d. children who lost a parent less than 6 months ago (since they may be experiencing a normal grief reaction and may not necessarily be in need of the treatment for CTG); e. caregiver of the child refuses to participate; f. lay counsellor is not literate; g. lay counsellor does not have a mobile phone; h. lay counsellor refuses to serve as a counsellor; i. site leader refuses to allow their site to participate in the study. Stated purpose: 1) identify actionable IPPs that predict adoption (delivery) and fidelity (high‐quality delivery) after 10 sites in each sector implement TF‐CBT (sequence 1). Use identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms. 2) Test mechanisms of implementation success in both sectors across all 7 sequences. 3) Test TF‐CBT effectiveness (i.e. mental health outcomes; functioning) and cost in both sectors |
| Interventions |
Intervention: Trauma‐focused cognitive behavioural therapy (Pamoja Tunaweza) ‐ Health (community health volunteer) sector These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of trauma‐focused cognitive behavioural therapy, in a community setting from community health volunteers. TF‐CBT intervention is composed of eight small‐group sessions, including eight children and one guardian for each child, and will meet separately, with joint activities in the final three sessions. TF‐CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting – with two lay counsellors leading the child group, and one leading the guardian group. Most TF‐CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2‐3 individual sessions mid‐group will be used for imaginal exposure (i.e. talking about/processing traumatic events). Control: Trauma‐focused cognitive behavioural therapy (Pamoja Tunaweza) ‐ Education (teacher) sector These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of trauma‐focused cognitive behavioural therapy, in their school setting from teachers employed by their school. |
| Outcomes |
Participants' outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (end of 8‐session treatment, assessed up to 18 weeks) |
| Starting date | 1 February 2018 |
| Contact information | Kathryn Whetten and Shannon Dorsey |
| Notes |
Source of funding: no clear specification for funding Prospective trial registration number: NCT03243396 |