Who is sponsoring NCT06125093?

NCT06125093 is sponsored by Fundació Sant Joan de Déu.

What drugs are being tested in NCT06125093?

Interventions in NCT06125093: Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®).

What condition does NCT06125093 study?

NCT06125093 studies Genetic Syndrome, Language Development, Autism or Autistic Traits, Parenting.

Is NCT06125093 still recruiting?

NCT06125093 is currently completed. Last updated 10 December 2025.

Last reviewed 2025-12-10 · How we verify

NCT06125093: The GAP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems

Completed NA Last updated 10 December 2025

What this trial tests

NA trial testing Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®) in Genetic Syndrome in 53 participants. Completed in 16 September 2024.

Timeline

14 March 2023

Primary endpoint
16 September 2024

16 September 2024

Quick facts

Lead sponsor	Fundació Sant Joan de Déu
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	14 March 2023
Primary completion	16 September 2024
Estimated completion	16 September 2024
Sites	3 locations across Spain

Drugs / interventions tested

Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)

Conditions studied

Genetic Syndrome — all drugs for Genetic Syndrome →
Language Development — all drugs for Language Development →
Autism or Autistic Traits — all drugs for Autism or Autistic Traits →
Parenting — all drugs for Parenting →

Sponsor

Fundació Sant Joan de Déu — full company profile →

Who can join

Adults 3 to 7, any sex, with Genetic Syndrome or Language Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The GAP study is a randomized controlled trial that aims to determine the feasibility and efficacy of the "Incredible Years Autism Spectrum and Language Delays" (IY-ASLD®) intervention for families of children with developmental problems from a genetic basis. It is a multicentric trial where families will randomly be assigned to the intervention group or to a control group (they will follow their usual treatment). The intervention will be carried out in an online format, and it will involve 22 weekly group sessions. The results of The GAP study will help clinicians and policy makers in guiding towards evidence-based treatment options for these particularly vulnerable group of infants.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): Study protocol for a pragmatic randomized controlled trial
Serrano M, Elias M, Llorens M, Bolasell M, et al · · 2024 · DOI 10.21203/rs.3.rs-4362581/v1
Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial.
Serrano M, Elias M, Llorens M, Bolasell M, et al · · 2024 · PMID 39033111 · DOI 10.1186/s13063-024-08278-4

Verify or expand the search:

Other recruiting trials for Genetic Syndrome

Currently open trials in the same condition.

NCT06666777 — Speech Therapy and Parenting for Early Socio-communicAtive sKills · NA · recruiting
NCT03967743 — Application of a Systematic Developmental Assessment to a Novel Population: Infants With Rare Genetic Disorders · recruiting

Other Fundació Sant Joan de Déu trials

Trials by the same sponsor.

NCT07508917 — Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation · Phase 1, PHASE2 · not yet recruiting
NCT06556251 — Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme · NA · recruiting
NCT06309121 — Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents · NA · active not recruiting
NCT07091344 — Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis · NA · recruiting
NCT06340555 — Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06125093 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundació Sant Joan de Déu
Last refreshed: 10 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06125093.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing