Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Social support: The Social Functional Support Questionnaire Duke-UNC
研究概览
简要总结
The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD). The main questions it aims to answer are:
- Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills),
- Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning).
- Treatment outcomes will be assessed at pre-test, post-test, and 3-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomes
Parents and teachers will complete different questionnaires to see if there are improvements on parent's and children outcomes.
Researchers will compare intervention group and control group to see if there are improvements on parent's domains (parenting stress, coping skills, social support) and children's dysfunctional outcomes (daily life functioning, social behavioral variables, and executive functioning).
详细描述
AIMS The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD).
The specific aims of this study are:
- to analyze whether a digital-based psychosocial program for parents of children with ASD and children with ADHD leads to an improvement of parent's outcomes (level of stress, coping skills, and perceived social support), in comparison with an active control group
- to examine whether a digital-based psychosocial program for parents of children with ASD and children with ADHD will lead to improvement of children outcomes, such as social difficulties, daily executive disfunctions, and sleep or learning problems, in comparison with an active control group
- Treatment outcomes will be assessed at pre-test, post-test, and 3-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomes
METHODOLOGY
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Families/children who meet the inclusion criteria will be randomly assigned to one of the two conditions (intervention group or control group) using a controlled design. Block randomization will be applied to each of the diagnostic groups (ASD, ADHD) to ensure that participants were of approximately similar size (1:1 ratio) in the treatment and control conditions. After determining the size of each block in the sample (#ASD and #ADHD) the treatment allocation of each individual participant will be done randomly.A blind procedure will be used: participating families will not know the group to which participants will be assigned, and the researchers who will collect and enter the data will also have no knowledge of the condition to which the families will be assigned.
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) diagnosis of ASD according to Autistic Diagnostic Interview-Revised (ADI-R; Rutter at al., 2006), and/or the Autism Diagnostic Observation Schedule, Generic (ADOS G; Lord et al., 2000) confirmed by child psychologist or ADHD any presentation according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition DSM-V; APA, (2013)] for parents and teachers
- •2) IQ> 80
- •3) age of children between 7 and 11 years, either sex
- •4) informed consent of the parents and the children available
- •5) parents' age greater than or equal to 18 years
- •6) responsibility and legal capacity in parents and access to internet.
排除标准
- •Exclusion criteria included subjects with any medical or psychiatric condition, an IQ of less than 80, motor or sensorial deficits, and children whose families had received any psychosocial treatment before.
研究组 & 干预措施
Digital Psychosocial Intervention group
The intervention group will be made up of five successive groups of 8 to 10 families that will receive 12 weekly 90-minute sessions in a synchronous virtual mode by zoom platform The integrity of the sessions will be guaranteed by a digital manual that clearly outlined all the procedures to be used in the intervention. Additionally, sessions will be audiotaped and reviewed by a team member through a checklist to ensure groups receive equivalent set of information.
干预措施: Digital Psychosocial intervention (Behavioral)
Control group
The control group of parents will be made up of another five successive groups of 8 to 10 families who will receive 12 sessions weekly 90 minutes. In these sessions these families will be encouraged to discuss their thoughts and share their experiences in a non-directive environment. The therapist will not be allowed to provide specific psychotherapy, psychoeducation or psychosocial techniques, nor any additional comments or information, but rather to guide the groups and allow everyone to express and give their personal point of view. The use of an active control group will ensure that the observed benefits are primarily due to the digitally supported psychosocial program only.
结局指标
主要结局
Social support: The Social Functional Support Questionnaire Duke-UNC
时间窗: Baseline and week 12 and week 36
The Social Functional Support is a validated parent report Questionnaire that measures the subjects' perception of the availability of help from family and friends in difficult situations. The instrument comprises 11 questions with a Likert-type scale ranging from 1 = "much less than I would like" to 5 = "as much as I would like". Scores of less than 32 indicate low perceived social support. The questionnaire presents good psychometric properties
Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation
时间窗: Baseline and week 12 and week 36
The parental distress subscale is a validated parent questionnaire that measures the level of distress a parent experiences due to personal factors. The scale provides a measure of total stress by adding up the scores on the 36 items, with a total score above 90 being clinically significant. The PSI-SF presents good psychometric properties
Children's social problems using Strengths and Difficulties Questionnaire (SDQ)
时间窗: Baseline and week 12 and week 36
The SDQ is a validated parent report questionnaire. This questionnaire has 25 items and is designed for children from 4 to 16 years old. The items are divided into 5 subscales: Emotional symptoms, Behavioral problems, Hyperactivity, Peer relationship problems, and Prosocial behaviors. In addition, it has a total difficulty score of behavioral problems obtained by adding together all the subscales except prosocial behavior. The items are scored on a Likert-type scale from 1 (not true) to 3 (completely true). On all the scales, a higher score implies greater difficulty, except the prosocial behavior scale, where a higher score is more positive than a lower one. The questionnaire presents good psychometric properties
Coping Skills using The Brief COPE
时间窗: Baseline and week 12 and week 36
The Brief COPE is a validated parent questionnaire that measures the usage frequencies of broad-based maladaptive and adaptive coping strategies. Items are rated on a four-point rating scale ranging from 1= 'I haven't been doing this at all' to 4= 'I've been doing this a lot'. The psychometric properties of the Brief COPE are good
Daily life executive functioning using the BRIEF
时间窗: Baseline and week 12 and week 36
The Behavioral Rating Inventory of Executive Function (BRIEF-2 Family report is a questionnaire completed by a relative/caregiver, which assesses daily executive functions. It consists of 63 items that are answered on a frequency scale (never, sometimes, and frequently). The raw scores are transformed into age-corrected T-scores. A score greater than 70 on any of the scales indicates clinically significant difficulties. Very high internal consistency has been reported
次要结局
- Behavioral problems using The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P)(Baseline and week 12 and week 36)
- Children Learning Behavior using Learning behavior scale (LBS)(Baseline and week 12 and week 36)
- Children Sleep problems: using The Sleep Disturbance Scale for Children (SDSC)(Baseline and week 12 and week 36)
研究者
Carmen Berenguer-Forner
Profesor Permanent Lecturer - Department of Developmental and Educational Psychology
University of Valencia