Clinical trial NCT02677142: Evaluating the Efficacy of a Group Social Skills Intervention
Official title: A Randomized Control Trial to Evaluate the Efficacy of a Group Social Skills Intervention for Childhood Survivors of Brain Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumours
Keywords: pediatric
Childhood Brain Tumour Survivors
Social Skills Rating System
social skills intervention program (SSIP)
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 95
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly, treatment strategies vary widely depending on child's age, tumour location, its resectability and histology. As a group, however, the survival rate of childhood brain tumors has improved in recent years, resulting in an increased number of survivors returning to school and reintegrating into their communities. Survival for many of them, however, has also come with severe costs such as neurocognitive and academic difficulties. Cognitive rehabilitation strategies to address these deficits have been a major focus of recent research. Evidence is now also mounting for social competence deficits among this population which may persist into late adolescence and adulthood, thereby negatively affecting long-term survivorship. Thus, there is an urgency to identify psychosocial interventions, such as social skills programs, that can reduce the social competence deficits in childhood brain tumor survivors and, therefore, modify the course of these outcomes to ensure that survivors thrive and become productive members of society. To date, no rigorous social skills intervention trials have been undertaken to address the social difficulties of these survivors. The current proposal is the first study that aims to address this gap by evaluating the efficacy of an innovative, manualized, social skills intervention program developed for this population using a multi-centre Randomized Control Trial (RCT).

Detailed description: Children and adolescents who are treated for brain tumours are faced with a variety of problems that affect the way they live their lives: one of the biggest problems is limited contact with friends and peers. This study aims to help kids and teens deal with this problem. The purpose of this study is to give kids who are treated for brain tumors opportunities to meet with other kids with similar experiences by participating in one of two social skills groups to improve how they related to one another. Investigators are assessing if these programs are beneficial to kids who have had brain tumours and which group is best. Kids will be assigned randomly to one of two groups. In both groups kids will meet with the other participants and with the facilitators for two hours once a week for 8 weeks. Kids in both groups will have introductions, group rules and group purpose (learn to relate with one another) through fun with games and arts and crafts. In one group, the games and crafts will be used for learning social skills. In the other group, arts and crafts and playing will be the focus of the activities, with the goal for each session determined by creating a craft or playing a game where everyone can win. One parent and all kids will complete questionnaires before the group starts, after the last group session as well as 6 months following the group. The questionnaires will ask questions about feeling, actions and getting along with others. Investigators also plan to visit the child's school so that the child, classmates and teachers will fill out questionnaires about friendships.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with a brain/spinal tumour
2. off treatment for at least 3 months or on maintenance chemotherapy but medically stable, e.g., low grade gliomas
3. between 8 and 16 years of age at the time of enrollment
4. have sufficient fluency in English for active group participation
5. attending school regularly and in a regular classroom for at least 50% of a school day

Exclusion Criteria:

1. Severe cognitive deficits, as defined by enrollment in full-time special classroom, which will prevent them from participating fully
2. a diagnosis of conduct disorder or any other condition that may interfere with group activities. Survivors and parents who have some difficulties reading (i.e., English is their second language) will be assisted by a research assistant (RA) in completing the questionnaires.

Primary outcomes:
measure: Parent-rated social skills - assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
measure: Child-rated social skills -- assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
Secondary outcomes:
measure: Quality of life ratings - general, parental assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
measure: Quality of life ratings - general, child assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
measure: Quality of life ratings - brain tumour module, parent assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
measure: Quality of life ratings - brain tumour module, child assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
measure: Child's social functioning - assessment of change across three time points
timeFrame: day 1, 8 weeks later, and 6 months after day 1
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Childrens Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Women and Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Maru Barrera, MD
role: PRINCIPAL_INVESTIGATOR
References:
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