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Evaluation of a Home-based Parenting Support Program: Parenting Young Children

Study acronym: PYC
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 14, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 31, 2024 to Mar 31, 2026
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    • Eligibility criteria revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Parents with intellectual and developmental disabilities (IDDs) have a tendency to provide insufficient caregiving and often need parenting support to prevent neglect and child removal. However, parents with IDDs are not provided with appropriate support, and there is a lack of evidence-based programmes tailored to these parents' needs. Parenting Young Children (PYC) is a home-based parenting programme developed for parents with IDDs. PYC has shown promising clinical results in interview-based studies, but there is no evidence of its effectiveness. The purpose of the proposed study is to evaluate the PYC programme for improving parenting in parents with IDDs where there is risk of child neglect. The study will include a quantitative evaluation, a process evaluation, and a qualitative evaluation of the children's and parents' perspectives on participating in PYC. Methods: The quantitative evaluation will have a multi-centre, non-randomised, comparative study design. Eligible for participation are parents with IDDs who have children aged 0-9 years living at home and who are assessed as needing tailored parenting support. Thirty parents receiving PYC and thirty parents receiving treatment as usual (TAU) will be recruited from Swedish municipal social services. Outcome variables will be examined before and after the intervention, with a follow-up 6 months after completing the intervention. The primary outcome will be goal-attainment in parenting skills, and secondary outcomes will be parental self-efficacy and children's wellbeing. Interview methods will be used to explore the perspectives of parents and children in the PYC group. Discussion: This study is motivated by the need for evidence-based support for parents with IDDs, and it focuses on upholding the centrality of child-caregiver relationships and family preservation, as well as children's rights and the rights of people with disabilities. Social services have expressed ethical concerns with employing a randomized design for this vulnerable group, and this study will therefore evaluate PYC in a non-randomized comparative study.
Trial Details
NCT Number NCT05935722
Lead Sponsor Örebro University, Sweden
Collaborators: Linkoeping University, Mälardalen University, Stockholm University, Uppsala University, Swedish Council for Working Life and Social Research
Conditions
(from sponsor)		 Intellectual Disability, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
Related terms Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov