protocolSection identificationModule nctId: NCT06303791, orgStudyIdInfo id: 1905517, briefTitle: Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders, acronym: INPSYD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-07, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: 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 outcomesParents 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)., conditionsModule conditions: Autism Spectrum Disorder, conditions: Attention Deficit Hyper Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To test the proposed objectives, a design will be used with a between-groups factor (type of therapy) and a intra-groups with pre-treatment (T0), post-treatment (T1) and follow-up measurements at 6 months (T2). Participants will be randomly assigned (1:1) to the two conditions; a group that will receive the intervention of the structured psychosocial program with digital support (experimental group) and an active control group. The experimental group will undergo an evaluation prior to the intervention, one immediately after it, and a third follow-up evaluation. In the case of the control group, it will be evaluated through the pretest phases, posttest and follow-up., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Digital Psychosocial intervention, outcomesModule primaryOutcomes measure: Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation, primaryOutcomes measure: Social support: The Social Functional Support Questionnaire Duke-UNC, primaryOutcomes measure: Coping Skills using The Brief COPE, primaryOutcomes measure: Children's social problems using Strengths and Difficulties Questionnaire (SDQ), primaryOutcomes measure: Daily life executive functioning using the BRIEF, secondaryOutcomes measure: Children Sleep problems: using The Sleep Disturbance Scale for Children (SDSC), secondaryOutcomes measure: Behavioral problems using The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P), secondaryOutcomes measure: Children Learning Behavior using Learning behavior scale (LBS), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False