Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders (NCT06303791) | Clinical Trial Compass
CompletedNot Applicable
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
Spain90 participantsStarted 2022-09-07
Plain-language summary
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:
1. Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills),
2. Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning).
3. 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).
Who can participate
Age range
7 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on parents of children with autism spectrum disorder or ADHD — given my child's specific diagnosis, would a digital psychosocial program like this one be appropriate for our situation, or is there something better suited to where we are right now?
2The trial measured parental stress using a tool called the PSI-SF — my stress levels are definitely something I'm struggling with, so can you tell me whether the results from this completed study suggest this kind of digital program actually helped parents feel less stressed?
3Since this trial also tracked social support and coping skills as outcomes, does that mean the program involved coaching or community connection, and is there any similar program you could refer me to now that this trial is finished?
4This trial was completed — does that mean the results have been published or reviewed, and if so, can we look at the findings together to decide whether a digital intervention makes sense as part of our family's care plan?
5Because this was a digital-based intervention, I want to understand the real-world demands — how much time and tech access would something like this typically require, and would it realistically work alongside everything else we're managing right now?'
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation
Timeframe: Baseline and week 12 and week 24
2
Social support: The Social Functional Support Questionnaire Duke-UNC