Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Children in this group receive 30 sessions of neurofeedback

The children in this group receive 30 sessions of placebo feedback, based on muscular tension.

The siblings will be tested 1 time, they will function as a healthy control group.

30 sessions of neurofeedback will be given twice a week at the child's home. It will take about 15 weeks to complete the training.

Neurofeedback

Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.

Placebo feedback

Introduction:

The aim of this study is to investigate the efficacy of neurofeedback (NFB) to improve attention, memory and processing speed in children treated for a Brain Tumour (BT). In the Netherlands every year approximately 100 children are diagnosed with a BT. Nowadays over 65% of these children have a 5-year survival. Treatment for a BT consists of neurosurgery and / or local or craniospinal radiation and / or adjuvant chemotherapy. Neurotoxicity caused by radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of neurocognitive decline in Childhood Brain Tumour Survivors (CBTS).

Approach:

Studies have shown that NFB has the capacity to improve the brain systems mediating selective attention and response inhibition in children with Attention Deficit/Hyperactive Disorder (ADHD). The effectiveness is reported as comparable to methylphenidate (Ritalin) without side effects of medication. CBTS exhibit symptoms comparable to those of children with ADHD and positive response to methylphenidate has been found in CBTS. However, NFB has not been used as an intervention in CBTS yet. The effectiveness of NFB in children treated for a BT will be investigated in a randomized controlled trial. The intervention group of 30 patients will receive approximately 30 sessions of NFB; the control group will receive 30 session of placebo neurofeedback. Neuropsychological tests will be used to evaluate pre- and post-NFB intervention as well as at a 6-month follow-up.

Relevance:

If NFB proofs to be effective for CBTS this will be a great improvement for their (neuro-) psychological functioning and quality of life, without the disadvantage of the side effects of medication. The implementation of this intervention might increase cognitive and social functioning and thus facilitate integration of these children in society during childhood and school carrier as well as in adult life.

Pediatric Research on Improving Speed, Memory and Attention

The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial

Dutch Cancer Society

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Herbal and Botanical

All Drugs and Chemicals

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.

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).

Structured social skills training program, SSIP

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.

CG - social skills activities

Maru Barrera, MD

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).

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.

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

Measured by Social Skills Rating System (SSRS)\[37\]. The SSRS is a standardized instrument that has parent, teacher and child versions.

Quality of Life Inventory - PedsQL, generic\[38\] - Parent report

Quality of Life Inventory - PedsQL, generic\[38\] - Child self-report

Quality of Life Inventory - PedsQL, Brain Tumour Module\[38\] - parent report

Quality of Life Inventory - PedsQL, Brain Tumour Module\[38\] - Child self-report

subscale of the Behavior Assessment System for Children-Second Edition, BASC-2, completed by parents

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pediatric Research on Improving Speed, Memory and Attention	NCT00961922	Brain Tumors	Neurofeedback Placebo feedbac...	8 Years - 18 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Evaluating the Efficacy of a Group Social Skills Intervention	NCT02677142	Brain Tumours	Structured soci... CG - social ski...	8 Years - 16 Years	The Hospital for Sick Children

Spots Global Cancer Trial Database for childhood brain tumour survivors