search
Back to results

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

Primary Purpose

Intellectual Disability, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Parenting Young Children
Treatment as Usual
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability focused on measuring Intellectual and developmental disabilities, parents, parenting skills, support programme

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Social Welfare OfficeRecruiting
  • Social Welfare OfficeRecruiting
  • Social Welfare OfficeRecruiting
  • Social Welfare OfficeRecruiting
  • Social Welfare OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parenting Young Children

Treatment as Usual

Arm Description

Home based parenting programme for supporting parent with IDDs. 3-6 months of structured coaching sessions.

Variety of interventions as usually provided by the social services.

Outcomes

Primary Outcome Measures

Change in Canadian Occupational Performance Measure, performance sub-scale.
1 Item, reported as 1-10 points.
Change in Canadian Occupational Performance Measure, satisfaction sub-scale.
1 Item, reported as 1-10 points.

Secondary Outcome Measures

Change in Parental Sense of Competence Scale.
15 items, reported as 15-90 points.
Strengths and Difficulties Questionnaire.
25 items, reported as 0-50 points.

Full Information

First Posted
June 29, 2023
Last Updated
June 29, 2023
Sponsor
Örebro University, Sweden
Collaborators
Linkoeping University, Mälardalen University, Stockholm University, Uppsala University, Swedish Council for Working Life and Social Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05935722
Brief Title
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
Collaborators
Linkoeping University, Mälardalen University, Stockholm University, Uppsala University, Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
Keywords
Intellectual and developmental disabilities, parents, parenting skills, support programme

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parenting Young Children
Arm Type
Experimental
Arm Description
Home based parenting programme for supporting parent with IDDs. 3-6 months of structured coaching sessions.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Variety of interventions as usually provided by the social services.
Intervention Type
Behavioral
Intervention Name(s)
Parenting Young Children
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measure, performance sub-scale.
Description
1 Item, reported as 1-10 points.
Time Frame
Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Title
Change in Canadian Occupational Performance Measure, satisfaction sub-scale.
Description
1 Item, reported as 1-10 points.
Time Frame
Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Secondary Outcome Measure Information:
Title
Change in Parental Sense of Competence Scale.
Description
15 items, reported as 15-90 points.
Time Frame
Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Title
Strengths and Difficulties Questionnaire.
Description
25 items, reported as 0-50 points.
Time Frame
Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tommie Forslund, PhD
Phone
+468163958
Email
tommie.forslund@psychology.su.se
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitta Wennberg, PhD
Email
birgitta.wennberg@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Strandberg, PhD
Organizational Affiliation
Örebro universitet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Social Welfare Office
City
Enköping
ZIP/Postal Code
749 35
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Svelander
Facility Name
Social Welfare Office
City
Jönköping
ZIP/Postal Code
551 89
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida Jönsson
Facility Name
Social Welfare Office
City
Motala
ZIP/Postal Code
591 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Nylén
Facility Name
Social Welfare Office
City
Tierp
ZIP/Postal Code
815 80
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Nilsson
Facility Name
Social Welfare Office
City
Uppsala
ZIP/Postal Code
751 40
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Wettervik

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs