Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs

NCT05750095 | Recruiting

• 1 other identifier: 2899
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

Autism spectrum disorders (ASD) are disabling and impairing conditions affecting 1% of children in Norway. ASD is hallmarked by severe social deficit and lack of independence causing reliance on supportive systems throughout life. Parents are usually the primary caretakers and support, often throughout life. Normal parenting skills are however often ineffective due to the social dysfunction of the child with ASD. This causes high stress as the demands exceed the resources and capability of the parent. The high stress is associated to increased risk for mental health problems, divorce, unemployment and reduced quality of life. High parent stress may also reduce the effect of interventions in ASD. However, although the need is great and parental follow-up is an integral part of health care for ASD children, there is a lack of evidence for such interventions. The current project aims to evaluate a specific parent program that is in clinical use - the Incredible Years for children with ASD - compared with a standardised treatment as usual (TAU) composed of clinical parent workshops ("first aid for parents"). The aim is to evaluate parenting interventions and promote evidence-based practice in a clinical setting. The investigators will perform a randomized controlled trial and qualitative interviews to compare the effectiveness of treatment as usual (TAU) versus a manualized parent program (IY-ASLD). The study aims to investigate if the parental program may reduce parent stress and improve parental competence and self-efficacy. Secondary goals are to investigate whether the parent program may improve quality of life for the parent and the child and have an impact on long-term child functioning and service use.

Conditions

Autism Spectrum Disorder

Keywords

Stress; Parenting; Autism

Outcome Measures

Primary Outcomes (3)

• Parenting Stress Index - 4 Short Form

  The PSI SF is a 36-item parental self-report questionnaire that assesses the stress related to interaction with the child, in relationship to the parents' personal situation and well-being. It has good psychometric properties and is one of the most commonly used questionnaires globally and is used in the corresponding studies of parental programs. To be filled in individually by all participating adults.

  Change from Baseline Parent Stress at 6 months

• Parenting Stress Index - 4 Short Form

  The PSI SF is a 36-item parental self-report questionnaire that assesses the stress related to interaction with the child, in relationship to the parents' personal situation and well-being. It has good psychometric properties and is one of the most commonly used questionnaires globally and is used in the corresponding studies of parental programs. To be filled in individually by all participating adults.

  Change from Baseline Parent Stress at 18 months

• Parenting Stress Index - 4 Short Form

  The PSI SF is a 36-item parental self-report questionnaire that assesses the stress related to interaction with the child, in relationship to the parents' personal situation and well-being. It has good psychometric properties and is one of the most commonly used questionnaires globally and is used in the corresponding studies of parental programs. To be filled in individually by all participating adults.

  Change from Baseline Parent Stress at 30 months

Secondary Outcomes (10)

• The Vineland Adaptive Behavior Scales - Second Edition

  Change from Baseline daily function of child at 18 months

• The Vineland Adaptive Behavior Scales - Second Edition

  Change from Baseline daily function of child at 30 months

• The Pediatric Quality of Life Inventory (PedsQL)

  Change from baseline child quality of life at 6 months

• The Pediatric Quality of Life Inventory (PedsQL)

  Change from baseline child quality of life at 18 months

• The Pediatric Quality of Life Inventory (PedsQL)

  Change from baseline child quality of life at 30 months

Study Arms (2)

Incredible Years Autism Spectrum and Language Delay Programme

EXPERIMENTAL

Incredible Years Autism Spectrum and Language Delay Programme is a manualised group based intervention in 13 weekly 2-hour sessions. The programme targets parents of children aged 2-6 years, with autism spectrum disorder or language delay.

Behavioral: Incredible Years Autism Spectrum and Language Delay Programme

First Aid for Parents

ACTIVE COMPARATOR

"First Aid for Parents" is a program consisting of three full day work-shops targeting communication, interaction and daily living skills for parents of children with autism spectrum disorders

Behavioral: First Aid for Parents

Interventions

Incredible Years Autism Spectrum and Language Delay Programme BEHAVIORAL

Incredible Years Autism Spectrum and Language Delay Programme is a manualised group based intervention in 13 weekly 2-hour sessions. The programme targets parents of children aged 2-6 years, with autism spectrum disorder or language delay.

Incredible Years Autism Spectrum and Language Delay Programme

First Aid for Parents BEHAVIORAL

"First Aid for Parents" is a program consisting of three full day work-shops targeting communication, interaction and daily living skills for parents of children with autism spectrum disorders

First Aid for Parents

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent of child diagnosed with an autism spectrum disorder, age 2-6

You may not qualify if:

• Level of Norwegian insufficient to benefit from a parental program without the use of an interpreter
• Ongoing major crisis in the family or major disabling condition in the participating parent
• Ongoing participation in another manualized (any) parent program

Sponsors & Collaborators

• University of Bergen: collaborator
• Norwegian University of Science and Technology: collaborator
• NORCE Norwegian Research Centre AS: collaborator
• Haukeland University Hospital: lead
• Helse Fonna: collaborator
• St. Olavs Hospital: collaborator

Study Sites (3)

Haukeland University Hospital

Bergen, Norway

RECRUITING

Helse Fonna

Haugesund, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

Related Publications (11)

• Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.

  PMID: 25898050 BACKGROUND

• Bieleninik L, Posserud MB, Geretsegger M, Thompson G, Elefant C, Gold C. Tracing the temporal stability of autism spectrum diagnosis and severity as measured by the Autism Diagnostic Observation Schedule: A systematic review and meta-analysis. PLoS One. 2017 Sep 21;12(9):e0183160. doi: 10.1371/journal.pone.0183160. eCollection 2017.

  PMID: 28934215 BACKGROUND

• Buescher AV, Cidav Z, Knapp M, Mandell DS. Costs of autism spectrum disorders in the United Kingdom and the United States. JAMA Pediatr. 2014 Aug;168(8):721-8. doi: 10.1001/jamapediatrics.2014.210.

  PMID: 24911948 BACKGROUND

• Cappe E, Wolff M, Bobet R, Adrien JL. Quality of life: a key variable to consider in the evaluation of adjustment in parents of children with autism spectrum disorders and in the development of relevant support and assistance programmes. Qual Life Res. 2011 Oct;20(8):1279-94. doi: 10.1007/s11136-011-9861-3. Epub 2011 Feb 12.

  PMID: 21312064 BACKGROUND

• Osborne LA, McHugh L, Saunders J, Reed P. Parenting stress reduces the effectiveness of early teaching interventions for autistic spectrum disorders. J Autism Dev Disord. 2008 Jul;38(6):1092-103. doi: 10.1007/s10803-007-0497-7. Epub 2007 Nov 20.

  PMID: 18027079 BACKGROUND

• Reinfjell T, Diseth TH, Veenstra M, Vikan A. Measuring health-related quality of life in young adolescents: reliability and validity in the Norwegian version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales. Health Qual Life Outcomes. 2006 Sep 14;4:61. doi: 10.1186/1477-7525-4-61.

  PMID: 16972987 BACKGROUND

• 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.

  PMID: 31961490 BACKGROUND

• Varni JW, Burwinkle TM, Seid M. The PedsQL as a pediatric patient-reported outcome: reliability and validity of the PedsQL Measurement Model in 25,000 children. Expert Rev Pharmacoecon Outcomes Res. 2005 Dec;5(6):705-19. doi: 10.1586/14737167.5.6.705.

  PMID: 19807613 BACKGROUND

• Kaminski JW, Valle LA, Filene JH, Boyle CL. A meta-analytic review of components associated with parent training program effectiveness. J Abnorm Child Psychol. 2008 May;36(4):567-89. doi: 10.1007/s10802-007-9201-9. Epub 2008 Jan 19.

  PMID: 18205039 BACKGROUND

• Lebersfeld JB, Swanson M, Clesi CD, O'Kelley SE. Systematic Review and Meta-Analysis of the Clinical Utility of the ADOS-2 and the ADI-R in Diagnosing Autism Spectrum Disorders in Children. J Autism Dev Disord. 2021 Nov;51(11):4101-4114. doi: 10.1007/s10803-020-04839-z. Epub 2021 Jan 21.

  PMID: 33475930 BACKGROUND

• Chatham CH, Taylor KI, Charman T, Liogier D'ardhuy X, Eule E, Fedele A, Hardan AY, Loth E, Murtagh L, Del Valle Rubido M, San Jose Caceres A, Sevigny J, Sikich L, Snyder L, Tillmann JE, Ventola PE, Walton-Bowen KL, Wang PP, Willgoss T, Bolognani F. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II. Autism Res. 2018 Feb;11(2):270-283. doi: 10.1002/aur.1874. Epub 2017 Sep 21.

  PMID: 28941213 BACKGROUND

Related Links

• Norwegian government document recommending parent programs for ASD follow-up

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

First Aid

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Officials

• Maj-Britt Posserud, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maj-Britt Posserud, MD, PhD

CONTACT

+479764183; maj-britt.rocio.posserud@helse-bergen.no

Trine Leikanger

CONTACT

trine.leikanger@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All measures are parent reported
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 1, 2023
• Study Start: January 10, 2022
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)