MedTrace Logo

Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders

NCT06303791 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-12-06

No results posted yet for this study

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 6-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).

Conditions

Interventions

BEHAVIORAL

Digital Psychosocial intervention

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).

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Principal Investigators

  • Carmen Berenguer, PhD · University of Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2024-11-17
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303791 on ClinicalTrials.gov