Clinical trial NCT05935722: Evaluation of a Home-based Parenting Support Program: Parenting Young Children
Official title: Evaluation of a Home-based Parenting Support Program - Parenting Young Children - for Parents With Intellectual and Developmental Disabilities When There is a Risk for Neglect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Keywords: Intellectual and developmental disabilities
parents
parenting skills
support programme
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Mälardalen University
name: Stockholm University
name: Uppsala University
name: Swedish Council for Working Life and Social Research
First posted: 2023-07-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Parents with IDDs, including ID and other cognitive disabilities (e.g., ADHD and ASD). Parents must have children aged 0-9 years living at home and be assessed by the social services to be eligible for tailored parenting support.

Exclusion Criteria:

* Ongoing substance abuse, ongoing child abuse, and/or mental illness of such nature and degree that it may affect parent management training.

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure, performance sub-scale.
timeFrame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
measure: Change in Canadian Occupational Performance Measure, satisfaction sub-scale.
timeFrame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Secondary outcomes:
measure: Change in Parental Sense of Competence Scale.
timeFrame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
measure: Strengths and Difficulties Questionnaire.
timeFrame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Other outcomes:
Locations:
city: Enköping
country: Sweden
facility: Social Welfare Office
city: Jönköping
country: Sweden
facility: Social Welfare Office
city: Motala
country: Sweden
facility: Social Welfare Office
city: Tierp
country: Sweden
facility: Social Welfare Office
city: Uppsala
country: Sweden
facility: Social Welfare Office
Study officials:
affiliation: Örebro universitet
name: Thomas Strandberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: