Clinical trial NCT06125093: Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems
Official title: Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genetic Syndrome
Language Development
Autism or Autistic Traits
Parenting
Keywords: early intervention
parenting
randomized controlled trial
pragmatic
genetic syndromes
mental health
development
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Vall d'Hebron Research Institute
name: Parc Taulí Hospital Universitari
name: Fundació La Marató de TV3
First posted: 2023-11-09
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Children born with genetic abnormalities have higher risk of presenting developmental and mental health problems. Their parents tend to express higher anxiety levels, as parenting children with developmental problems can be a stressful challenge for many families. These infants can present important behaviour, emotion regulation and social interaction problems. These problems usually have a complex clinical presentation determined by their genetic abnormality. Despite many of their impairing symptoms can overlap with the characteristics of the Autism Spectrum Disorder (ASD), in many cases they do not meet criteria for a full-blown ASD diagnosis. These patients are placed in a double disadvantaged situation, as on top of suffering a genetic disease, they do not usually enter the ASD care-pathways and do not have access to effective therapies for their impairing symptoms. This problem should be addressed, as there is wide scientific evidence on early parenting programs that improve infants' developmental problems and parents' mental health. These parenting programs are structured interventions that provide parenting skills to improve the acquisition of children's social and emotion regulation abilities. Such interventions have been widely implemented internationally, but unfortunately, most families treated within our mental health system still do not have access to them. A good example is the parenting program "Incredible Years Autism Spectrum and Language Delays (IY-ASLD®)", focused on improving young children's development and parental stress levels. Recently, the feasibility and acceptability of implementing this program in different areas of the national territory has been studied, with high satisfaction levels expressed by participant families (parents of children with language delays or ASD). However, the scientific evidence is very limited for children with developmental problems from a genetic basis, particularly for those with dysfunctional symptoms' that do not meet diagnostic threshold for an ASD diagnosis.

The GAP study aims to determine, for the first time, the feasibility and efficacy of the IY-ASLD® intervention for families of children with developmental problems from a genetic basis. It is a multicentric randomized controlled trial where families will randomly be assigned to the intervention group or to a control group (they will follow their usual treatment). As genetic abnormalities are rare, clinicians will carry out the intervention in an online format (22 weekly sessions), reaching out all affected families that live scattered throughout the national territory. 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.

Eligibility criteria: Inclusion Criteria:

1. Children aged 3.0 - 7.11 years at recruitment
2. Children with a diagnosis or in diagnostic process for high suspicion of a genetic abnormality
3. For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\> 65) AND/OR pervasive developmental problems (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\> 65) AND/OR socialization difficulties (defined as Vineland-III scores below 1SD in the socialization subdomains).
4. For children over 6 years with social problems (defined as CBCL/6-18 scores above the borderline clinical range, T-score\> 65) AND/OR thought problems (defined as CBCL/6-18 scores above the borderline clinical range, T-score\> 65) AND/OR socialization difficulties (defined as Vineland-III scores below 1SD in the socialization subdomains).
5. Parents/caregivers showing good understanding of the Spanish or Catalan language
6. Parents/caregivers consenting to take part in the study and signing the informed consent

Exclusion Criteria:

1. Children diagnosed with an Autism Spectrum Disorder
2. Children scoring above diagnostic cut-off for Autism or Autism Spectrum Disorder in the ADOS-2.
3. Attending another structured parenting program
4. Children in the care of their local authority

Primary outcomes:
measure: Percentage of parents engaging with and finishing the program
timeFrame: Attendance sheet completed weekly throughout treatment (22 weeks total)
measure: Compliance and satisfaction throughout the study (Autism Program Parent Weekly Evaluation)
timeFrame: Questionnaire administered to the intervention group weekly throughout treatment (22 weeks total)
measure: Parents' acceptability and satisfaction with the program (evaluated with the Autism Program Parent Final Satisfaction Questionnaire)
timeFrame: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline)
measure: Parents' overall experiences with the program (evaluated with individual interviews)
timeFrame: Interviews to the participants of the intervention group at treatment completion (approximately 22 weeks after baseline)
Secondary outcomes:
measure: Changes from baseline to post-intervention in Parent Stress Inventory-Short Form (PSI-SF)
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
measure: Changes from baseline to post-intervention in Alabama Parenting Questionnaire-Preschool revision (APQ-Pr)
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
measure: Changes from baseline to post-intervention in Beck Depression Inventory (BDI)
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
measure: Changes from baseline to post-intervention in Autism-Specific Five Minute Speech Sample (ASFMFSS)
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
measure: Clinicians' experiences with the intervention delivered
timeFrame: Interviews to clinicians at treatment completion (approximately 22 weeks after baseline)
Other outcomes:
Locations:
city: Esplugues De Llobregat
country: Spain
facility: Sant Joan de Deu
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
Study officials:
affiliation: Hospital Sant Joan de Déu. Fundació Privada per a la Recerca i la Docència Sant Joan de Déu
name: Laia Villalta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Vall d'Hebron Institut de Recerca
name: Anna Maria Cueto-González, MD
role: STUDY_CHAIR
affiliation: Parc Taulí Hospital Universitari
name: Carmen Manso, MD
role: STUDY_CHAIR
affiliation: Hospital Sant Joan de Deu
name: Mercedes Serrano, MD, PhD
role: STUDY_CHAIR
References:
citation: Valencia F, Urbiola E, Romero-Gonzalez M, Navas I, Elias M, Garriz A, Ramirez A, Villalta L. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD(R) program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Trials. 2021 Apr 20;22(1):291. doi: 10.1186/s13063-021-05229-1.
citation: Landa RJ. Efficacy of early interventions for infants and young children with, and at risk for, autism spectrum disorders. Int Rev Psychiatry. 2018 Feb;30(1):25-39. doi: 10.1080/09540261.2018.1432574. Epub 2018 Mar 14.
citation: Morel A, Peyroux E, Leleu A, Favre E, Franck N, Demily C. Overview of Social Cognitive Dysfunctions in Rare Developmental Syndromes With Psychiatric Phenotype. Front Pediatr. 2018 May 3;6:102. doi: 10.3389/fped.2018.00102. eCollection 2018.
citation: Richards C, Jones C, Groves L, Moss J, Oliver C. Prevalence of autism spectrum disorder phenomenology in genetic disorders: a systematic review and meta-analysis. Lancet Psychiatry. 2015 Oct;2(10):909-16. doi: 10.1016/S2215-0366(15)00376-4. Epub 2015 Sep 1.
citation: Webster-Stratton C, McCoy KP. Bringing The Incredible Years(R) Programs to Scale. New Dir Child Adolesc Dev. 2015 Fall;2015(149):81-95. doi: 10.1002/cad.20115.
citation: Williams ME, Hastings RP, Hutchings J. The Incredible Years Autism Spectrum and Language Delays Parent Program: A Pragmatic, Feasibility Randomized Controlled Trial. Autism Res. 2020 Jun;13(6):1011-1022. doi: 10.1002/aur.2265. Epub 2020 Jan 21.