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IRCT2013120614338N1 IRCT 2013-12-06 Laurentian Universiry The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Children with Cancer The effectiveness of Modified Mindfulness-based Cognitive Therapy for hospitalized Children Hospitalized with Cancer compared to control group in attention problems and internalizing problems. 2013-09-01 anticipated 40 Complete https://irct.ir/trial/14018 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: We utilized simple randomization through the excel file of random numbers. The unit of randomization was individual. N/A Condition 1: cancer. Condition 2: anxiety. Condition 3: depression. Condition 4: somatic complaints. Condition 5: attention problems. Intervention 1: Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment as usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45 min. Sessions were conducted 5 times weekly for 4 weeks. Primary outcome measures were the Child Behavior Checklist, Parent Report and its companion instrument, and the Youth Self-Report (YSR). Data were collected at pre-intervention, post-intervention, and at 2 months following the intervention. Intervention 2: Forty youth were age and gender-matched, and then randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). Mahak hospital provided some welfare services and social work services. Welfare services as well as social work services was equal for both experimental and control group. Social workers were assigned to accompany the child and help the family to become acquainted with the cancer, available services, hospital procedure and personnel, and disjunctive treatment. Moreover, they facilitated a shared playroom that every child welcomed to join. They could use from various toys there and made friend with others. Parents could accompany their children there. And the group was lead by social workers. The room was open 2 hours daily from 2 pm to 4 pm. Children could use from snacks there and remaining there was not mandatory. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is we have not decided yet for sharing the data set.
public samaneh abedini najafabadi
866, prete st
sudbury Canada P3E 3Y1 +1 647-763-2962 sabedini_najafabadi@laurentian.ca Laurentian Universiry scientific Mojtaba Habibi
Shahid Beheshti University, Tehran, Evin
Tehran Iran (Islamic Republic of) 1983969411 +98 21 29901 babakhabibius@yahoo.com Shahid Beheshti University Iran (Islamic Republic of) Hospitalized patients were eligible to participate in the Mindfulness-Based Cognitive Therapy for Children (MBCT-C) program in addition to receiving TAU if they were (a) 11 to 13 years of age; (b) had at least average fluency in Persian; (c) had received the first diagnosis of any type of cancer except brain cancers; (d) were undergoing radiation therapy and/or chemotherapy through the hospital’s oncology division; and (e) had not received any psychological interventions or psychiatric medications in the six months preceding the study. Diagnostic inclusion criteria were: (f) a diagnosis of Autism spectrum disorder (ASD) (Diagnostic and Statistical Manual of Mental Disorders (IV) (DSM-IV (American Psychiatric Association, 2000); and (g) at least two comorbid diagnoses in any of four diagnostic categories (anxiety, depression, psychosomatic, or attention deficit disorders). Diagnoses were ascertained using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Persian version (K-SADS-PL-P). Additionally, patients needed to be: (h) in the borderline or clinical range for internalizing problems (T-score ≥ 60) and attention problems (T-score ≥ 57) on at least two of four subscales of the Child Behavior Checklist (CBCL) or Youth Self-Report (YSR )(depression/anxiety, withdrawal/depression, somatic complaints, and attention problems) at the screening assessment. 11 years 13 years Both Patients who were determined to (i) have a major cognitive dysfunction or developmental disability, or (j) was diagnosed with a terminal illness (defined as having a prognosis of fewer than six months) were excluded. Moreover, Brain cancers were excluded based on research suggesting that these may affect attention (Raghubar et al., 2017), a key outcome variable. F06.30 F06.4 F06.31 F06.4 F90 Mood disorder due to known physiological condition, unspecified Anxiety disorder due to known physiological condition Mood disorder due to known physiological condition with depressive features Anxiety disorder due to known physiological condition Attention-deficit hyperactivity disorders Treatment - Other Other Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment as usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45 min. Sessions were conducted 5 times weekly for 4 weeks. Primary outcome measures were the Child Behavior Checklist, Parent Report and its companion instrument, and the Youth Self-Report (YSR). Data were collected at pre-intervention, post-intervention, and at 2 months following the intervention. Forty youth were age and gender-matched, and then randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). Mahak hospital provided some welfare services and social work services. Welfare services as well as social work services was equal for both experimental and control group. Social workers were assigned to accompany the child and help the family to become acquainted with the cancer, available services, hospital procedure and personnel, and disjunctive treatment. Moreover, they facilitated a shared playroom that every child welcomed to join. They could use from various toys there and made friend with others. Parents could accompany their children there. And the group was lead by social workers. The room was open 2 hours daily from 2 pm to 4 pm. Children could use from snacks there and remaining there was not mandatory. Internalizing and attention problems. Timepoint: Before and 4 weeks after the treatment as well as 2-month follow-up. Method of measurement: CBCL and YSR. More cooperation in medical treatments in participants. Timepoint: Before and after the treatment as well as at follow-up point. Method of measurement: Interviews. The main researcher (samaneh abedini) Approved 2013-08-27 Shahid Beheshti University Shahid Beheshti University, Evin, Tehran. Tehran Tehran Iran (Islamic Republic of)