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Evaluating the Efficacy of a Group Social Skills Intervention

Primary Purpose

Brain Tumours

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Structured social skills training program, SSIP
CG - social skills activities
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumours focused on measuring pediatric, Childhood Brain Tumour Survivors, Social Skills Rating System, social skills intervention program (SSIP)

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alberta Childrens Hospital
  • BC Women and Children's Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Attention Control Group (CG)

Experimental Group (EG)

Arm Description

Behavioural: CG: Social Skills Activities: Participants in this arm will experience an 8-week manualized intervention program with activities and games. Sessions will NOT be designed around a specific social skill and activities and games will NOT have a specific focus. Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.

Behavioral: Structured social skills training program, SSIP. Participants in this arm will experience an 8-week manualized intervention program that addresses six major social skills, one per session, starting with easier skills (Social Initiation and Friendship Making, Cooperation) and moving towards more complex skills (Managing Teasing and Bullying, Conflict Resolution, Empathy, and Assertion). Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.

Outcomes

Primary Outcome Measures

Parent-rated social skills - assessment of change across three time points
Measured by Social Skills Rating System (SSRS)[37]. The SSRS is a standardized instrument that has parent, teacher and child versions.
Child-rated social skills -- assessment of change across three time points
Measured by Social Skills Rating System (SSRS)[37]. The SSRS is a standardized instrument that has parent, teacher and child versions.

Secondary Outcome Measures

Quality of life ratings - general, parental assessment of change across three time points
Quality of Life Inventory - PedsQL, generic[38] - Parent report
Quality of life ratings - general, child assessment of change across three time points
Quality of Life Inventory - PedsQL, generic[38] - Child self-report
Quality of life ratings - brain tumour module, parent assessment of change across three time points
Quality of Life Inventory - PedsQL, Brain Tumour Module[38] - parent report
Quality of life ratings - brain tumour module, child assessment of change across three time points
Quality of Life Inventory - PedsQL, Brain Tumour Module[38] - Child self-report
Child's social functioning - assessment of change across three time points
subscale of the Behavior Assessment System for Children-Second Edition, BASC-2, completed by parents

Full Information

First Posted
December 14, 2015
Last Updated
May 6, 2016
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02677142
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumours
Keywords
pediatric, Childhood Brain Tumour Survivors, Social Skills Rating System, social skills intervention program (SSIP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control Group (CG)
Arm Type
Active Comparator
Arm Description
Behavioural: CG: Social Skills Activities: Participants in this arm will experience an 8-week manualized intervention program with activities and games. Sessions will NOT be designed around a specific social skill and activities and games will NOT have a specific focus. Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
Arm Title
Experimental Group (EG)
Arm Type
Experimental
Arm Description
Behavioral: Structured social skills training program, SSIP. Participants in this arm will experience an 8-week manualized intervention program that addresses six major social skills, one per session, starting with easier skills (Social Initiation and Friendship Making, Cooperation) and moving towards more complex skills (Managing Teasing and Bullying, Conflict Resolution, Empathy, and Assertion). Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
Intervention Type
Behavioral
Intervention Name(s)
Structured social skills training program, SSIP
Intervention Description
Detailed, session by session, in the manual written for this purpose. It addresses six major social skills, one per session, starting with easier skills (Social Initiation and Friendship Making, Cooperation) and moving towards more complex skills (Managing Teasing and Bullying, Conflict Resolution, Empathy, and Assertion).
Intervention Type
Behavioral
Intervention Name(s)
CG - social skills activities
Intervention Description
Sessions will not be designed around a specific social skill and activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
Primary Outcome Measure Information:
Title
Parent-rated social skills - assessment of change across three time points
Description
Measured by Social Skills Rating System (SSRS)[37]. The SSRS is a standardized instrument that has parent, teacher and child versions.
Time Frame
day 1, 8 weeks later, and 6 months after day 1
Title
Child-rated social skills -- assessment of change across three time points
Description
Measured by Social Skills Rating System (SSRS)[37]. The SSRS is a standardized instrument that has parent, teacher and child versions.
Time Frame
day 1, 8 weeks later, and 6 months after day 1
Secondary Outcome Measure Information:
Title
Quality of life ratings - general, parental assessment of change across three time points
Description
Quality of Life Inventory - PedsQL, generic[38] - Parent report
Time Frame
day 1, 8 weeks later, and 6 months after day 1
Title
Quality of life ratings - general, child assessment of change across three time points
Description
Quality of Life Inventory - PedsQL, generic[38] - Child self-report
Time Frame
day 1, 8 weeks later, and 6 months after day 1
Title
Quality of life ratings - brain tumour module, parent assessment of change across three time points
Description
Quality of Life Inventory - PedsQL, Brain Tumour Module[38] - parent report
Time Frame
day 1, 8 weeks later, and 6 months after day 1
Title
Quality of life ratings - brain tumour module, child assessment of change across three time points
Description
Quality of Life Inventory - PedsQL, Brain Tumour Module[38] - Child self-report
Time Frame
day 1, 8 weeks later, and 6 months after day 1
Title
Child's social functioning - assessment of change across three time points
Description
subscale of the Behavior Assessment System for Children-Second Edition, BASC-2, completed by parents
Time Frame
day 1, 8 weeks later, and 6 months after day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with a brain/spinal tumour off treatment for at least 3 months or on maintenance chemotherapy but medically stable, e.g., low grade gliomas between 8 and 16 years of age at the time of enrollment have sufficient fluency in English for active group participation attending school regularly and in a regular classroom for at least 50% of a school day Exclusion Criteria: Severe cognitive deficits, as defined by enrollment in full-time special classroom, which will prevent them from participating fully 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maru Barrera, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Childrens Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
BC Women and Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15610986
Citation
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Results Reference
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PubMed Identifier
12733151
Citation
Reddick WE, White HA, Glass JO, Wheeler GC, Thompson SJ, Gajjar A, Leigh L, Mulhern RK. Developmental model relating white matter volume to neurocognitive deficits in pediatric brain tumor survivors. Cancer. 2003 May 15;97(10):2512-9. doi: 10.1002/cncr.11355.
Results Reference
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PubMed Identifier
10550145
Citation
Copeland DR, deMoor C, Moore BD 3rd, Ater JL. Neurocognitive development of children after a cerebellar tumor in infancy: A longitudinal study. J Clin Oncol. 1999 Nov;17(11):3476-86. doi: 10.1200/JCO.1999.17.11.3476.
Results Reference
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PubMed Identifier
11843068
Citation
Butler RW, Copeland DR. Attentional processes and their remediation in children treated for cancer: a literature review and the development of a therapeutic approach. J Int Neuropsychol Soc. 2002 Jan;8(1):115-24.
Results Reference
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PubMed Identifier
8863462
Citation
Radcliffe J, Bennett D, Kazak AE, Foley B, Phillips PC. Adjustment in childhood brain tumor survival: child, mother, and teacher report. J Pediatr Psychol. 1996 Aug;21(4):529-39. doi: 10.1093/jpepsy/21.4.529.
Results Reference
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PubMed Identifier
9782676
Citation
Vannatta K, Gartstein MA, Short A, Noll RB. A controlled study of peer relationships of children surviving brain tumors: teacher, peer, and self ratings. J Pediatr Psychol. 1998 Oct;23(5):279-87. doi: 10.1093/jpepsy/23.5.279.
Results Reference
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PubMed Identifier
20680353
Citation
Schulte F, Barrera M. Social competence in childhood brain tumor survivors: a comprehensive review. Support Care Cancer. 2010 Dec;18(12):1499-513. doi: 10.1007/s00520-010-0963-1. Epub 2010 Aug 1.
Results Reference
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PubMed Identifier
16130127
Citation
Barrera M, Shaw AK, Speechley KN, Maunsell E, Pogany L. Educational and social late effects of childhood cancer and related clinical, personal, and familial characteristics. Cancer. 2005 Oct 15;104(8):1751-60. doi: 10.1002/cncr.21390.
Results Reference
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PubMed Identifier
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Citation
Zebrack BJ, Gurney JG, Oeffinger K, Whitton J, Packer RJ, Mertens A, Turk N, Castleberry R, Dreyer Z, Robison LL, Zeltzer LK. Psychological outcomes in long-term survivors of childhood brain cancer: a report from the childhood cancer survivor study. J Clin Oncol. 2004 Mar 15;22(6):999-1006. doi: 10.1200/JCO.2004.06.148.
Results Reference
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Evaluating the Efficacy of a Group Social Skills Intervention

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