Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems (The GAP)

Fundació Sant Joan de Déu

Status: Completed

Conditions: Autism or Autistic Traits; Parenting; Genetic Syndrome; Language Development

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06125093

434/U/2022 (Other Grant/Funding Number)

PIC-168-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Intervention group

Experimental group

Description:

Those in the intervention group will participate in a weekly group-based online intervention for approximately 6 months (Incredible Years-Autism Spectrum and Language Delays Parent Program, IY-ASLD®). Families allocated to the intervention group will also receive treatment as usual (TAU).

Treatment:

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

Treatment as usual (TAU) group

No Intervention group

Description:

The TAU condition involves outpatient appointments with different paediatric specialists in the hospitals of the 3 sites of the study. Depending on the patients' needs, some cases will be assisted in early years centers or child mental health centers based in the community.