Evaluating the Efficacy of a Group Social Skills Intervention

NCT02677142 | Completed

• 1 other identifier: 1000014297
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

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).

Conditions

Brain Tumours

Keywords

pediatric; Childhood Brain Tumour Survivors; Social Skills Rating System; social skills intervention program (SSIP)

Outcome Measures

Primary Outcomes (2)

• 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.

  day 1, 8 weeks later, and 6 months after day 1

• 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.

  day 1, 8 weeks later, and 6 months after day 1

Secondary Outcomes (5)

• Quality of life ratings - general, parental assessment of change across three time points

  day 1, 8 weeks later, and 6 months after day 1

• Quality of life ratings - general, child assessment of change across three time points

  day 1, 8 weeks later, and 6 months after day 1

• Quality of life ratings - brain tumour module, parent assessment of change across three time points

  day 1, 8 weeks later, and 6 months after day 1

• Quality of life ratings - brain tumour module, child assessment of change across three time points

  day 1, 8 weeks later, and 6 months after day 1

• Child's social functioning - assessment of change across three time points

  day 1, 8 weeks later, and 6 months after day 1

Study Arms (2)

Attention Control Group (CG)

ACTIVE COMPARATOR

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: CG - social skills activities

Experimental Group (EG)

EXPERIMENTAL

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.

Behavioral: Structured social skills training program, SSIP

Interventions

Structured social skills training program, SSIP BEHAVIORAL

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).

Experimental Group (EG)

CG - social skills activities BEHAVIORAL

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.

Attention Control Group (CG)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (3)

Alberta Childrens Hospital

Calgary, Alberta, Canada

Location

BC Women and Children's Hospital

Vancouver, British Columbia, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

Related Publications (9)

• Butler RW, Mulhern RK. Neurocognitive interventions for children and adolescents surviving cancer. J Pediatr Psychol. 2005 Jan-Feb;30(1):65-78. doi: 10.1093/jpepsy/jsi017.

  PMID: 15610986 BACKGROUND

• 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.

  PMID: 12733151 BACKGROUND

• 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.

  PMID: 10550145 BACKGROUND

• 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.

  PMID: 11843068 BACKGROUND

• 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.

  PMID: 8863462 BACKGROUND

• 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.

  PMID: 9782676 BACKGROUND

• 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.

  PMID: 20680353 BACKGROUND

• 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.

  PMID: 16130127 BACKGROUND

• 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.

  PMID: 15020603 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maru Barrera, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: February 9, 2016
• Study Start: April 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

CA (3)