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

Autism Spectrum Disorder Clinical Trial

— PYC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935722
• Other study ID #: ORU 4.2-00340/2023
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Örebro University, Sweden
• Contact: Tommie Forslund, PhD
• Phone: +468163958
• Email: tommie.forslund[@]psychology.su.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Developmental Disabilities
• Intellectual Disability

Intervention

Behavioral:
• Parenting Young Children
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.
• Treatment as Usual
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.

Locations

Country	Name	City	State
Sweden	Social Welfare Office	Enköping
Sweden	Social Welfare Office	Jönköping
Sweden	Social Welfare Office	Motala
Sweden	Social Welfare Office	Tierp
Sweden	Social Welfare Office	Uppsala

Sponsors (6)

Lead Sponsor	Collaborator
Örebro University, Sweden	Linkoeping University, Mälardalen University, Stockholm University, Swedish Council for Working Life and Social Research, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Canadian Occupational Performance Measure, performance sub-scale.	1 Item, reported as 1-10 points.	Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Primary	Change in Canadian Occupational Performance Measure, satisfaction sub-scale.	1 Item, reported as 1-10 points.	Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Secondary	Change in Parental Sense of Competence Scale.	15 items, reported as 15-90 points.	Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Secondary	Strengths and Difficulties Questionnaire.	25 items, reported as 0-50 points.	Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)