Efficacy of Psychological Intervention for Children With Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorPakistan Institute of Medical Sciences
About this trial
The study will be conductued at the Pediatric Oncology Department of the Children's Hospital, PIMS Islamabad, over the peroid of six months. This single-blinded, two-arm RCT study will involve 80 children aged 8 to 16 years with maligancies recieving chemotherapy. Participants will be randomly allocated to either interventional or CBT group which will recieve weekly five sessions of Cognitive Behaviour Therapy (CBT) or the control group, which will recieve the usual care. CBT session will be contducted by Clinical Psychologist will last 30-35 minutes. Outcomes will be measured at Baseine and one month post intervention using Revised Child Anxiety and Depression Scale (RCADS) and Pediatric Quality of Life Generic Core Score 4.0.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 16-18 years
Diagnosed with malignancy
Recieving chemotherapy at the Pediatric Oncology Department of PIMS Islamabad
Able to understand and participate in CBT sessions
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Interventiion or CBT Group
BehavioralThis RCT aims to evaluate the effect of Cognitive Behavioral Therapy (CBT) compared to usual care (UC) in pediatric oncology patients. We hypothesize that those receiving CBT will report lower depression and anxiety and improved QoL six months post-enrollment.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Interventional GroupExperimental treatment 1 intervention
Group B: Control or Usual Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Revised Child Anxiety and Depression Scale (RCADS)
The RCADS is a standardized, self reported scale measuring anxiety and depression symptoms among children aged 8-18 years.
Time frame
Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)Secondary outcomes
1
Pediatric QoL
It evaluates physical, emotional, social and school funtioning.
Time frame
Baseline and one month post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: