Clinical trial · Interventional
Evaluating the Efficacy of a Group Social Skills Intervention
A Randomized Control Trial to Evaluate the Efficacy of a Group Social Skills Intervention for Childhood Survivors of Brain Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumours | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CG - social skills activities | Behavioral | — | UNRESOLVED |
| Structured social skills training program, SSIP | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Attention Control Group (CG)
- 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.
- interventionNames
- Behavioral: CG - social skills activities
- type
- EXPERIMENTAL
- label
- Experimental Group (EG)
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDButler 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
- BACKGROUNDReddick 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
- BACKGROUNDCopeland 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
- BACKGROUNDButler 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
- BACKGROUNDRadcliffe 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
- BACKGROUNDVannatta 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
- BACKGROUNDSchulte 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
- 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.