Intellectual DisabilityPYCNCT05935722
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
A study testing Parenting Young Children and Treatment as Usual in people with Intellectual Disability and Attention Deficit Hyperactivity Disorder, run by Örebro University, Sweden at 5 sites in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intellectual Disability, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
- What is being tested?
- Parenting Young Children and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesSweden
- Study dates
- 8 Sep 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Ongoing substance abuse, and/or mental illness of such nature and degree that it may affect parent management training.
- Ongoing child abuse.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Birgitta Wennberg, PhD contact
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Social Welfare Office
Enköping, 749 35
Helena Svelander
- Recruiting
Social Welfare Office
Jönköping, 551 89
Ida Jönsson
- Recruiting
Social Welfare Office
Motala, 591 86
Anna Nylén
- Recruiting
Social Welfare Office
Tierp, 815 80
Ann Nilsson
- Recruiting
Social Welfare Office
Uppsala, 751 40
Anette Wettervik
About this study
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
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.
- Conditions
- Intellectual Disability, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
- Being tested
- Parenting Young Children, Treatment as Usual
- Keywords
- Intellectual and developmental disabilities, parents, parenting skills, support programme
- Medical subject headings
- Intellectual Disability, Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Young ChildrenBehavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Young Children | Experimental | Home based parenting programme for supporting parent with IDDs. 3-6 months of structured coaching sessions. Receives: Behavioral: Parenting Young Children |
| Treatment as Usual | Active comparator | Variety of interventions as usually provided by the social services. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure, performance sub-scale.
1 Item, reported as 1-10 points.
Measured: 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.
Measured: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Secondary outcomes (2)
Change in Parental Sense of Competence Scale.
15 items, reported as 15-90 points.
Measured: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Strengths and Difficulties Questionnaire.
25 items, reported as 0-50 points.
Measured: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start8 Sep 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Mälardalen University, Stockholm University, Uppsala University, Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
- Investigators
- Thomas Strandberg, PhD, Principal investigator, Örebro universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935722
- Sponsor's protocol ID
- ORU 4.2-00340/2023
- Acronym
- PYC
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05935722
- Acronym / sponsor ID
- PYC / ORU 4.2-00340/2023
- Conditions
- Intellectual Disability, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
- Keywords
- Intellectual and developmental disabilities, parents, parenting skills, support programme
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Linkoeping University, Mälardalen University, Stockholm University, Uppsala University, Swedish Council for Working Life and Social Research
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Young Children | Experimental | Behavioral: Parenting Young ChildrenHome based parenting programme for supporting parent with IDDs. 3-6 months of structured coaching sessions. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualVariety of interventions as usually provided by the social services. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Ongoing substance abuse, and/or mental illness of such nature and degree that it may affect parent management training.
- Ongoing child abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting Young ChildrenPYC 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. | Behavioural | Parenting Young Children |
| Treatment as UsualTAU 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. | Behavioural | Treatment as Usual |
Primary outcome
Change in Canadian Occupational Performance Measure, performance sub-scale.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
1 Item, reported as 1-10 points.
Change in Canadian Occupational Performance Measure, satisfaction sub-scale.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
1 Item, reported as 1-10 points.
2 secondary outcomes
Change in Parental Sense of Competence Scale.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Strengths and Difficulties Questionnaire.
Time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Intellectual Disability
Active, not recruiting
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Rett Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Technology-supported Motor Rehabilitation for People With Rett Syndrome
Rett Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgitta Wennberg, PhD contact
Thomas Strandberg, PhD principal investigator
Örebro universitet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Young Children and Treatment as Usual in people with Intellectual Disability and Attention Deficit Hyperactivity Disorder, run by Örebro University, Sweden at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommie Forslund, PhD (+468163958, tommie.forslund@psychology.su.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Occupational Performance Measure, performance sub-scale. (time frame: Baseline (pre-intervention), 3-6 months (post-intervention), 9-12 months (follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.