Nervous System Diseases

Symptoms and General Pathology

All Conditions

Gait Disorders, Neurologic

Neurologic Manifestations

One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks.

Horse-Assisted Rehabilitation

Jordi Esquirol Caussa, PhD, MD

Teresa Xipell Prunés, PT

Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.

Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.

Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.

Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics

Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).

Pediatric Quality of Life Inventory - Parent-Proxy Report (PedsQL-PC) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).

Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).

State Trait Ansiety IInventory for children (STAI-CH) - norm-referenced scores (T scores and percentile ranks) for each one of the two subscales: Anxiety-Trait \& Anxiety-State (scores 0-60 in each subscale, higher = worse).

Childhood Depression Inventory (CDI), self report long version (28 items) to assess the presence and severity of depressive symptoms in children. Scores range from 0-56, with higher scores indicating higher levels of depression.

Behavior Assessment System for Children - Parent Rating Scale (BASC-PRS), second version (BASC-2) - BASC-2 is parent-reported, well-established scale for externalizing/internalizing problem of children and adolescents. Scoring manual and software is provided by the assessment developers; norm-referenced scores (T scores and percentile ranks) are available in the score reports, as are interpretations of strengths and weaknesses and target behaviors for intervention (mean of 50 and standard deviation of 10; for the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic).

PedsQL-C (subscale Health and Activities: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

PedsQL-PC (subscale Physical Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

PedsQL-C (subscale Feelings: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

PedsQL-C (subscale Get Along with Others: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

Pediatric Balance Scale (PBS: 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks; Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The highest score in PBS is 56, higher is better).

Sitting Assessment Scale (Sitting Assessment Scale (SAS) is a standardized observational instrument designed for assessment of sitting in children with cerebral palsy (CP); the scale is composed of five items evaluating head, trunk and foot control and arm and hand function, where each item is assessed with a score from 1 to 4 (1 =none; 2=poor; 3=fair; 4=good) and each score (1,2,3,4) has specific decriptors of each item of the SAS).

Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07: the DCDQ is a brief questionnaire designed to screen for coordination disorders in children, aged 5 to 15 years, and consists of 15 items grouped into three distinct factors (motor control during movement, fine motor and handwriting and general coordination; to reach scores, sum each column to compute the numbers onto the Score Sheet, and add all factor scores to compute a Total Score: 0-75, higher is better).

Heart Rate Variability (HRV, low/high frequency (LH/FH) power ratio; modulation of heart rate variability assessed through analysis of data collected by HRV wireless monitorisation and PolarH7(R) thoracic band (medical device), following the American and European Cardiological Societies).

Hospital Vall d'Hebron

Hospital Sant Joan de Deu

Escoles Universitaries Gimbernat

Neoplasms

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

Dermatologic Agents

All Drugs and Chemicals

Sunscreening Agents

Only "I am Protecting my Child From the Sun" program was given.

The "I am Protecting my Child From the Sun" program was given. After the program, an SMS message was sent on Wednesday and Saturday for 12 weeks. A total of 25 SMS messages were sent to remind the subject and applications.

No attempt was made by the researcher during the study. Only data collection was carried out. At the end of the research, the "I am Protecting my Child From the Sun" program was given..

The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks.

Intervention groups received Sun Protection Guide for Parents, Developmental, Characteristics of 3-6 Age Group Children Brochure, Melanoma Brochure, Video, Frame, Key chain, Magnet, Puzzle, Sunscreen product, T-shirt, hat and UV testing wristband.

I Am Protecting My Child from the Sun

While the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week.

SMS for sun protection

Selma Öncel, PhD, RN, Professor

This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. The "I Am Protecting My Child from the Sun" program, based on Social Cognitive Theory, and the sending of short reminder messages had positive effects on the parents' behaviors related to protecting themselves and their children from the sun.

This study aimed to examine the effect of the "I Am Protecting My Child from the Sun" program, based on social cognitive theory, on parents' sun-protection product use and sun avoidance behaviors. Organized as a randomized controlled experimental study conducted on three groups with a pre- and post-test follow-up design, the study was carried out in Manavgat between April 2018 and October 2018 and included the participation of 185 parents, of which 63 were in the education group, 62 were in the education+SMS group, and 60 were in the control group. The parents in the intervention group were administered the "I Am Protecting My Child from the Sun" program for a period of six weeks, while the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week. Data were collected using the Parent Information Form, Skin Cancer Risk Perception Form, Skin Cancer and Sun Knowledge Scale, Parental Self-Efficacy Scale, Parental Sun Protection Scales, and Parent Behaviors Regarding Protecting Themselves and Their Children from The Sun Question Form.

I am Protecting my Child From the Sun Program

Effect of the "I am Protecting my Child From the Sun" Program Based on Social Cognitive Theory, on Parent Behaviors

I want to share "I am Protecting my Child From the Sun" program protocol with other researchers.

The Self-Efficacy of the Use of Sunscreen Products consists of 5 items, Norms/Attitudes for the Use of Sunscreen Products consists of 6 items, Expectancies for the Use of Sunscreen Products consists of 6 items and Impediments to the Use of Sunscreen Products consists of 3 items in products; The Self - Efficacy of Sun Avoidance consists of 5 items, Norms/Attitudes for Sun Avoidance consists of 4 items, Tanning Expectancies consists of 4 items and Expectancies for Sun Avoidance consists of 5 items in Parental Sun Protection Scales. To calculate the scores of the scale, the items are numbered from 1 to 5. Each subscale will be evaluated within itself in the scales and it is expected that the scales of Impediments to the Use of Sunscreen Products and Tanning Expectancies scales have low scores and the other scales have high scores.

The questionnaire is prepared according to the literature and consists of Sun Protection Applications of Parents for Themselves and Sun Protection Applications of Parents for Child's sections and five questions. It questions the sun protection practices for sunscreen, long-sleeved clothing, hat, sunglasses and shade. Answers to questions range from "never", " sometimes" and "always".

The Skin Cancer and Sun Knowledge Scale consists of 25 items and evaluates information about five fields: the indications of sun protection, suntanning, skin cancer risk factors, prevention of skin cancer, and skin cancer. The items consist of 15 correct-incorrect and 10 multiple-choice questions. For each item, correct answers are symbolized by (1) and incorrect by (0). Total points are 0-25 on the scale. The higher the score obtained, the higher the knowledge level.

In the Skin Cancer Risk Perception questionnaire, there is a question that questions parents' risk of developing skin cancer, and two questions that question the possibility of developing skin cancer over the next 10 years and their lives. Parents' skin cancer risk perception was grouped between "very low" and "very high" and evaluated between 1 and 10 points, respectively. The increase in the score obtained is interpreted as high risk perception.

Parental Competence Scale consists of 11 items and one dimension to evaluate parents' parenting skills. The lowest 11 points and the highest 77 points can be obtained from the scale.

Skin self-examination practices were obtained by asking.

Akdeniz University

Principal Investigator

Wounds and Injuries

Rare Diseases

Brain Neoplasms

Brain Injuries

Brain Diseases

Brain Injury, Chronic

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Brain Damage, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Brain Tumor, Childhood

Seven individualized meetings with the family (7 sessions whereof most will be videoconferences, with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 meetings (three videoconferences and one phone call) with school and local care providers during a period of 4-5 months.

Based on target outcomes areas noted by children and parents, individual goals will be established (2-5 per family). Strategies to meet goals will be established for each goal, and goal attainment scaling will be used to quantify goal attainment.

Usual health care and rehabilitation services provided in the municipality, including school.

Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family

Family centered in-home rehabilitation

Control

Marianne Løvstad, PhD

Children with acquired brain injury (ABI) often struggle with complex impairments, including cognitive (such as memory and attention), social, emotional and behavioral challenges. There is a lack of evidence-based knowledge about rehabilitation for children with ABI in the chronic phase. The current study, the CICI Study, is a randomized controlled trial (RCT) directed towards children with ABI and their families in the chronic phase.

The study will be conducted in close collaboration with schools and local health care providers. The CICI Study focuses on the child's and parents' individually identified target outcome areas and rehabilitation goals. The intervention aims to enhance everyday functioning in the home and school environment by attaining rehabilitation goals in areas noted as challenging by the participants. The efficacy of the CICI-intervention will be measured in terms of goal attainment, burden of brain injury related symptoms, parenting self-efficacy, unmet health care needs, as well as several aspects of child, parent and family functioning.

There is considerable knowledge about how to help children with ABI during the first, acute and post-acute stages. Yet, impairments are often long lasting and, due to the vulnerability of children's developing brain, new problems may emerge or become increasingly problematic over time. Children with ABI may struggle at school and with peers, which can lead to or increase emotional difficulties, and reduce quality of life, affecting the children and their families. The local communities and the children's schools are, together with the families, often left responsible for dealing with the chronic challenges of pABI. Parents may experience considerable stress and develop emotional symptoms when a child suffers an ABI. As a result, the entire family may experience impaired functioning, which in turn may affect the long-term prognosis of the child with ABI.

Eighty families will be included in the study: 40 in the intervention group and 40 in the control group. The children will have a clinical ABI diagnosis, verified injury related intracranial abnormalities, and be at least one year post injury at inclusion. The children and/or their families must report enduring cognitive, emotional, social or physical challenges related to the brain injury. The intervention will be conducted in collaboration with the children's families, schools and their local health care providers. It consists of individualized goal-oriented strategies adapted to the home- and school-setting. Goal attainment scaling will be applied. In addition, psychoeducation will be provided to the family and school/local care providers on topics related to the child's injury. A parent group session will be held for discussions and knowledge transfer concerning family challenges after pABI, such as communication skills and parenting. The intervention will include 7 individualized meetings with the family (7 sessions whereof most will be videoconferences, but with the possibility of 1-2 of the sessions being home visits), one parent group seminar and 4 sessions with school and local health care providers during a period of 4-5 months.

Assessments will be conducted at baseline (T1), at the end of the intervention (T2, 4-5 months after inclusion) and one year after inclusion (T3). Baseline assessment includes a brief neuropsychological assessment of the children in addition to the outcome measures at T2 and T3. Outcome assessors will ble blinded to group allocation. Primary outcomes are change in parent-reported brain injury symptoms of the children and change in parenting self-efficacy. Secondary outcomes include change in child-rated severity of brain injury symptoms, change in unmet healthcare needs of the family, change in children's executive functioning in the home and school environment as assessed by parents, children and teachers, change in children's quality of life assessed by parents and children, change in family functioning, change in caregiver emotional symptoms, an evaluation of the intervention completed by parents, children and teachers in the intervention group, change in the perceived severity of the individually defined target outcome areas completed by children and parents, and change in goal attainment scaling in the intervention group.

The findings of this study will contribute to enhanced clinical expertise within pABI-rehabilitation on a specialist health care level, and will also be relevant for a wide array of health care professionals in the community as well as the educational system and parents of children with ABI.

Independent Outcome Assessor(s) will be blinded to group allocation. Participants will be provided with new IDs in final database, blinding researchers to which group is the intervention group during analysis.

The Child in Context Intervention Study

Treating Chronic Symptoms of Pediatric Acquired Brain Injury - The Child In Context Intervention Study

Assessed with the Health and Behavior Inventory (HBI) on a scale from 0 (Never) to 3 (Often), where higher score indicates more severe symptoms.

The Tool to measure Parenting Self-Efficacy (TOPSE) is rated on a scale from 0 (completely disagree) to 10 (completely agree). Higher total score on the questionnaire indicates higher parenting self-efficacy.

Assessed with the Family Needs Questionnaire - Pediatric version - FNQ-P on a scale from 1 (the need is not at all met) to 5 (completely met). Higher total score indicates higher level of met needs.

Assessed with the Behavior Rating Inventory of Executive Function 2 - BRIEF-2 on a 3-point scale: Never a problem, sometimes a problem or often a problem. Higher scaled score indicates higher level of problems with executive functioning.

Assessed with the Pediatric Quality of Life Inventory - Peds-QL scored on a scale from 0 (never a problem) to 4 (almost always a problem). Higher scaled score indicates higher quality of life.

Assessed with the family Assessment Device - FAD on a 4-point scale: Strongly agree, agree, disagree and strongly disagree. Lower total scaled score represents better family functioning.

Assessed with the Patient Health Questionnaire 9 - PHQ-9 on a scale from 0 (not at all) to 3 (almost every day). Higher mean score reflects a higher level of depressive symptoms.

Generalized Anxiety Disorder 7 - GAD-7 on a scale from from 0 (not at all) to 3 (almost every day). Higher mean score reflects a higher level of anxiety symptoms.

A custom-made evaluation questionnaire for the CICI Study will be completed by parents, children and teachers in the intervention group, as well as therapists. The Evaluation form is rated on a 5-point scale from "completely disagree" to "completely agree". Higher scaled score indicates higher degree of satisfaction.

Each of the participating family members (parent(s) and child) nominate their three most important problems (target outcome areas) and how difficult they find them on a scale from 0 (not at all difficult) to 4 (very difficult), where . changes in the difficulty scores are evaluated. A negative change indicates a decrease in perceived difficulty.

Goal Attainment Scaling (GAS) is assessed by GAS-scaling of individually defined goals (scale from 1 to 5). A higher positive change reflects higher level of goal attainment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects	NCT04070131	Cancer Child, Only Child Behavior Neurologic Gait... Neurologic Comp...	Horse-Assisted ...	4 Years - 18 Years	Escoles Universitaries Gimbernat
I am Protecting my Child From the Sun Program	NCT04251598	Skin Neoplasms Parents Behavior and Be... Child Behavior Health Behavior	I Am Protecting... SMS for sun pro...	-	Akdeniz University
The Child in Context Intervention Study	NCT04798859	Rehabilitation Brain Injuries Brain Injury, C... Brain Diseases Family Childhood Brain... Child Behavior Parenting	Family centered... Control	6 Years - 16 Years	Sunnaas Rehabilitation Hospital
The Child in Context Intervention Study	NCT04798859	Rehabilitation Brain Injuries Brain Injury, C... Brain Diseases Family Childhood Brain... Child Behavior Parenting	Family centered... Control	6 Years - 16 Years	Sunnaas Rehabilitation Hospital

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