An interventional study of Parenting Young Children and Treatment as Usual in Intellectual Disability, Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, sponsored by Örebro University, Sweden. Recruiting at 5 sites in Sweden. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Home based parenting programme for supporting parent with IDDs. 3-6 months of structured coaching sessions.
Behavioral: Parenting Young Children
Variety of interventions as usually provided by the social services.
Behavioral: Treatment as Usual
PYC is a home-based intervention programme involving weekly, one-hour sessions over a period of at least six months. The programme has two core modules (1) Parent-Child Interaction and (2) Child Care Skills and Safety. The Parent-Child Interaction module focuses on the parent-child relationship and interaction skills such as parents' responsiveness to the child's signals, giving the child attention and encouragement, and supporting prosocial behaviour. The Child Care Skills and Safety module targets safety at home and the parent's caring skills (e.g. food, health, and hygiene). Checklists are adapted to each parent in order to support the PYC practitioner and the parent. The programme is compiled in a manual that includes work tasks, instructions for how to perform the tasks, and teaching materials.
TAU consists of a variety of interventions from the social services. The support will be logged and classified in accordance with the Swedish National Board of Health and Welfare's guidelines for classifications of its activities. TAU will be divided into the following five categories: 1) conversation counselling or emotional support, 2) practical support, 3) skills training, 4) compensatory strategies, and 5) other support. Support will also be classified based on whether it is home-based or given outside the home and whether it is individualised or in a group setting.
Change in Canadian Occupational Performance Measure, performance sub-scale.
1 Item, reported as 1-10 points.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Change in Canadian Occupational Performance Measure, satisfaction sub-scale.
1 Item, reported as 1-10 points.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Change in Parental Sense of Competence Scale.
15 items, reported as 15-90 points.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Strengths and Difficulties Questionnaire.
25 items, reported as 0-50 points.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Plan to share: No
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Örebro University, Sweden