]>
IRCT20260716070216N1 IRCT 2026-07-21 National University of Science and Technology, Islamabad Feasibility and Accessibility of Bounce Back Program for Managing Trauma in Pakistani Children: A Pilot Randomized Controlled Trials Bounce Back Program Trials Feasibility and Accessibility of Bounce Back Program for Managing Trauma in Pakistani Children: A Pilot Randomized Controlled Trials 2025-12-15 anticipated 500 Complete https://irct.ir/trial/91725 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Pilot randomized controlled trial with a pretest–posttest wait-list control design and follow-up assessment, Randomization description: Participants were randomly allocated to either the intervention group or the wait-list control group in a 1:1 allocation ratio using a computer-generated randomization sequence. The random allocation sequence was generated by an independent statistician who was not involved in participant recruitment, baseline assessment, or intervention delivery. Stratified randomization was performed separately within each participating school based on gender and grade level to ensure balanced allocation across groups. Allocation concealment was maintained until completion of baseline assessments. Following randomization, participants in the intervention group received the culturally adapted Bounce Back Program in a school-based group format, whereas participants in the wait-list control group continued receiving routine school support services and were offered the intervention after completion of the post-intervention assessment, Blinding description: Single-blind (blinded outcome assessment). Two independent outcome assessors, each holding an MS degree in Psychology, remained blinded to participants' group allocation throughout baseline, post-intervention, and follow-up assessments. The assessors were not involved in participant randomization or intervention delivery, thereby minimizing assessment bias. 1-2 Trauma Symptoms. Intervention 1: Intervention group: The intervention group received the culturally adapted Urdu version of the Bounce Back Program, a trauma-focused cognitive behavioral intervention for children aged 8–11 years experiencing trauma symptoms. The program consisted of 10 structured group sessions and 3 individual sessions delivered over approximately 10 weeks. Each session lasted approximately 45–60 minutes. The intervention was delivered by the principal researcher (clinical psychologist) who was trained in the Bounce Back intervention protocol. Two additional trained clinical psychologists were involved in monitoring treatment fidelity and ensuring adherence to the intervention manual. The intervention included psychoeducation about trauma, relaxation and coping skills, emotion identification and regulation, cognitive restructuring, trauma narrative activities, problem-solving skills, safety planning, and parent psychoeducation/home practice activities. Intervention 2: Control group: The control group was assigned to the wait-list condition. Participants continued their routine school activities and did not receive the Bounce Back intervention during the study period. They underwent the same assessment procedures as the intervention group at pre-test, post-test, and follow-up stages. After completion of the study assessments, participants in the wait-list control group were offered the intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is No. De-identified individual participant data will not be made publicly available due to ethical considerations, participant confidentiality, and institutional data protection policies.
public Dr Tamkeen Ashraf
10
Rawalpindi Pakistan 44000 +92 322 5028262 tamkeen.ashraf@s3h.nust.edu.pk NUST, DBS, S3H scientific Dr Tamkeen Ashraf
10
Rawalpindi Pakistan 44000 +92 322 5028262 tamkeen.ashraf@s3h.nust.edu.pk NUST, DBS, S3H Pakistan Had experienced one or more potentially traumatic events. Children between 8 and 11 years of age. Children who score 15 to 20 on CATS(Child and Adolescent Trauma Screen) screening scale Children enrolled in Grades 3, 4 and 5 of participating in school. 8 years 11 years Both any children with neuro-developmental disorder any children with PTSD any children on medication Reported sexual abuse as their primary traumatic experience F43.9 Reaction to severe stress, unspecified Behavior N/A Intervention group: The intervention group received the culturally adapted Urdu version of the Bounce Back Program, a trauma-focused cognitive behavioral intervention for children aged 8–11 years experiencing trauma symptoms. The program consisted of 10 structured group sessions and 3 individual sessions delivered over approximately 10 weeks. Each session lasted approximately 45–60 minutes. The intervention was delivered by the principal researcher (clinical psychologist) who was trained in the Bounce Back intervention protocol. Two additional trained clinical psychologists were involved in monitoring treatment fidelity and ensuring adherence to the intervention manual. The intervention included psychoeducation about trauma, relaxation and coping skills, emotion identification and regulation, cognitive restructuring, trauma narrative activities, problem-solving skills, safety planning, and parent psychoeducation/home practice activities. Control group: The control group was assigned to the wait-list condition. Participants continued their routine school activities and did not receive the Bounce Back intervention during the study period. They underwent the same assessment procedures as the intervention group at pre-test, post-test, and follow-up stages. After completion of the study assessments, participants in the wait-list control group were offered the intervention. Anxiety and Depression Symptoms. Timepoint: pre, post and follow-up. Method of measurement: Measured through approved questionnaires in Urdu-Language. Resilience, Behavioral Functioning and Emotional Regulation. Timepoint: Pre, Post and Follow-Up. Method of measurement: all measured through approved questionnaires. National University of Science and Technology, Islamabad Approved 2026-01-21 NUST Research Ethics Committee H12 Islamabad Islamabad Capital Territory Pakistan