CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled / 90 target
Drug / intervention
Digital Psychosocial interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06303791
NCT06303791N/ACompletedHigh Momentum (2.0/mo)Completion was 28mo ago

Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders: a Randomized Control Trial

University of Valencia·interventional·Posted Mar 12, 2024·Updated Jun 11, 2026

In Brief

A clinical study evaluating Digital Psychosocial intervention for Autism Spectrum Disorder and Attention Deficit Hyper Activity. Completed, enrolled 90 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 12, 2024
Enrollment StartSep 7, 2022
Primary CompletionFeb 17, 2024
Study CompletionSep 5, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 2.3 years ago

Arms & Interventions

Digital Psychosocial Intervention groupexperimental

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.

Behavioral: Digital Psychosocial intervention
Control groupno_intervention

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.

Interventions

Digital Psychosocial interventionbehavioral

The psychosocial program with digital support has been developed by combining different theoretical perspectives on intervention in children with ASD without intellectual disabilities and children with ADHD. The contents of the program are based on three main approaches, each of which has separately demonstrated evidence in the treatment of these neurodevelopmental disorders: psychoeducation and stress management, cognitive behavioral techniques, and techniques in social and communication skills (Dahl et al., 2020; DuPaul et al., 2020; Tan-MacNeill et al., 2021).