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

Parenting Clinical Trial

— The GAP  

Official title:

Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125093
• Other study ID #: PIC-168-22
• Secondary ID: 434/U/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Fundació Sant Joan de Déu
• Contact: Laia Villalta, MD, PhD
• Phone: +34936009751
• Email: laia.villalta[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Genetic Syndrome
• Language Development
• Parenting

Intervention

Behavioral:
• Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)
The IY-ASLD® program is a weekly group-based intervention for parents of children presenting neurodevelopmental problems (ASD symptoms, communication or language difficulties). The group is formed by 6-10 parents, and it is led by a group leader and a co-therapist, trained in the model. The intervention is manualized. It includes video modelling and emphasizes the importance of practice-based learning through role-playing. The IY-ASLD® program takes into consideration the different developmental levels of each child and pairs parents according to this variable in role-play and other one-to-one discussions. Weekly home tasks will be assigned to parents, and families will be phoned each week to encourage home-based practice. The intervention will be conducted online. Even though the IY-ASLD® original intervention comprises 14 sessions, the online format requires 22 weekly sessions. Fidelity to the intervention will be assessed in accordance with the regulations of the program.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Sant Joan de Deu	Esplugues De Llobregat	Barcelona
Spain	Hospital Universitari Parc Taulí	Sabadell

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Fundació La Marató de TV3, Hospital Universitari Vall d'Hebron Research Institute, Parc Taulí Hospital Universitari

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of parents engaging with and finishing the program	Parents' attendance at the sessions will be regeristered weekly with a sheet of attendance, with the aim to determine levels of compliance and engagement with the intervention. An attendance of at least 15/22 sessions is expected, with a minimum of 50% of parents finishing the program.	Attendance sheet completed weekly throughout treatment (22 weeks total)
Primary	Compliance and satisfaction throughout the study (Autism Program Parent Weekly Evaluation)	Parents' compliance and satisfaction with the intervention will be assessed weekly after each session with the questionnaire "Autism Program Parent Weekly Evaluation", which is part of the IY-ASLD® program materials.	Questionnaire administered to the intervention group weekly throughout treatment (22 weeks total)
Primary	Parents' acceptability and satisfaction with the program (evaluated with the Autism Program Parent Final Satisfaction Questionnaire)	Parents' acceptability and satisfaction with the program will be assessed with the Autism Program Parent Final Satisfaction Questionnaire (included within the IY-ASLD® program). Data will be collected after the last session of the intervention.	Administered to the intervention group at treatment completion (approximately 22 weeks after baseline)
Primary	Parents' overall experiences with the program (evaluated with individual interviews)	Individual interviews will be conducted after the last session of the intervention to explore from a qualitative perspective: (1) parents' acceptability, satisfaction and overall experience with the intervention, and (2) parents' perceived changes in their parenting skills and parental distress after the intervention.; Outcome measurements 3 and 4 will be combined to determine parents' experiences, acceptability and satisfaction with the program.	Interviews to the participants of the intervention group at treatment completion (approximately 22 weeks after baseline)
Secondary	Changes from baseline to post-intervention in Parent Stress Inventory-Short Form (PSI-SF)	The PSI-SF is a 36-item questionnaire that specifically focuses on assessing parental stress associated with the care of their offspring. It has three domains: parental distress, parent-child dysfunctional interaction, and difficult child, which combine to form a total stress scale. This tool will be administered before and after the intervention. It has shown good internal consistency.	Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
Secondary	Changes from baseline to post-intervention in Alabama Parenting Questionnaire-Preschool revision (APQ-Pr)	The APQ-Pr is a 32-item parent-reported questionnaire measuring parenting practices that are consistently associated with disruptive child behaviors. This version has 3 dimensions: positive parenting, inconsistent parenting, and punitive parenting. It will be collected before and after the intervention. This measure has shown good internal consistency and validity.	Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
Secondary	Changes from baseline to post-intervention in Beck Depression Inventory (BDI)	The BDI is a 21-item screening tool assessing the severity of depressive symptoms. It is a standardized and validated questionnaire, often used in mood disorder assessments. It will be collected before and after the intervention. It has good reliability.	Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
Secondary	Changes from baseline to post-intervention in Autism-Specific Five Minute Speech Sample (ASFMFSS)	ASFMFSS is a narrative 5-min interview used to measure parental-expressed emotions for children with ASD and related disorders. Parents are asked to speak about their child and the parent-child relationship. Speech samples are audiotaped, transcribed, and coded following four global categories: (a) initial statement, (b) warmth, (c) relationship, (d) emotional over-involvement, (e) critical comments, and (f) positive comments. Expressed emotions will be measured before and after the intervention. Inter-rater reliability and code-recode reliability of this measure have been shown to be good to excellent.	Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)
Secondary	Clinicians' experiences with the intervention delivered	Individual interviews will be conducted after the last session with clinicians who delivered the intervention.	Interviews to clinicians at treatment completion (approximately 22 weeks after baseline)