Evaluation of the parenting support group intervention "Everyday life and parenting" for parents of preschool children with neurodevelopmental difficulties
| ISRCTN | ISRCTN10835479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10835479 |
- Submission date
- 16/08/2024
- Registration date
- 08/10/2024
- Last edited
- 06/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Young children with subclinical neurodevelopmental disorders (NDDs) and concurrent emotional and behavioral problems (EBP) are at significant risk of negative consequences in the short and long term. Early parenting support interventions are recommended and requested. However, there is a lack of interventions specifically designed for this group and adapted to a Swedish context. Based on this gap, a parenting support intervention for parents with children 2 - 6 years of age with subclinical NDD and EBP has been co-created with clinicians and parents. The current project aims to evaluate the clinical- and cost-effectiveness of this parenting support group intervention.
Who can participate?
Parents of children aged 2 - 6 years old with subclinical levels of NDD and behavioral problems. The children have been referred to child health psychologists at the Child Pediatric Outpatient Clinic in Uppsala Region. Children aged 4 – 6 years old whose parents consented to participate in the project, will be invited to participate themselves.
What does the study involve?
Parents offered the parenting support group intervention Everyday life and parenting will be included in the baseline (4, 7 or 10 weeks) and they will thus start the intervention after the baseline period. They will answer 25 questions every week during the baseline, the intervention and four weeks after the intervention. The questions are about their child's behavior, their own self-efficacy as parents and stress. They will also answer questionnaires at the start of baseline, when the intervention is finished and three months after the intervention.
Children aged 4 - 6 years old will answer 5 questions weekly during the same time period as their parent.
What are the possible benefits and risks of participating?
The potential benefit of participating in the research project is that parents are given the opportunity to reflect on their parenting and thus gain a greater awareness of the family's challenges. Based on this, it can be easier for parents to recognise what support they and their children need. It can also be meaningful to share your own experiences and perspectives and through this contribute to knowledge that can be used to help other parents and children in similar situations.
Children may enjoy answering a questionnaire that asks about their experiences in the family. This can make them feel that their opinions are important. It is rare for children of pre-school age to be involved in similar studies and this project gives them the opportunity to make their voices heard and thus fulfil a human right.
Where is the study run from?
The Child Health and Parenting (CHAP) research group at Uppsala University (Sweden) together with the Child Pediatric Outpatient Clinic in Uppsala Region.
When is the study starting and how long is it expected to run for?
January 2024 to December 2026
Who is funding the study?
Swedish Research Council for Health, Working Life and Welfare
Foundation Sunnerdahls Disability Fund (Sweden)
Who is the main contact?
Dr Karin Fängström, karin.fangstrom@uu.se
Contact information
Scientific, Principal Investigator
Husargatan 3
Uppsala
75123
Sweden
 ORCID ID |
0000-0001-9879-941X |
|---|---|
| Phone | 0184716576 |
| karin.fangstrom@uu.se |
Public
Husargatan3
Uppsala
75123
Sweden
| Phone | 0184716576 |
|---|---|
| ida.hedkvist@uu.se |
Study information
| Study design | Multiple-baseline single-case experimental design (SCED) across participants with pre- and post-measures and a 3-month follow-up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The clinical- and cost-effectiveness of a parenting support group intervention for parents of preschool children with subclinical neurodevelopmental disorders and mental health problems |
| Study objectives | Children's behavioral problems, reported by parents, will decrease as an effect of the intervention, that parent's self-efficacy will increase and their stress will decrease |
| Ethics approval(s) |
Approved 05/06/2024, The Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2024-03064-01 |
| Health condition(s) or problem(s) studied | Subclinical neurodevelopmental disorders and mental health problems |
| Intervention | Current interventions as of 08/11/2024: The parenting support group intervention "Everyday life and parenting" consist of four modules. The intervention is theoretically based in social-learning theory and it uses methods from applied behavior analysis, e.g., functional behavior assessment, as well as structured teaching. Three of the intervention modules includes key components from the most effective parenting programs targeting behavior problems in children. Parenting techniques taught during the intervention includes positive parenting skills such as positive reinforcement techniques, relationship enhancement techniques and reframing unhelpful cognitive perceptions about the child. The fourth intervention module is based on theories and knowledge from treatment provided to children with autism and/or intellectual disabilities as well as the ICF framework. Important elements in this module are teaching parents how to organize the physical environment, create activity schedules, visual schedules and/or cues, establish routines with flexibility, and use visually structured activities. These elements create clarity and predictability in everyday life. Furthermore, the module includes teaching parents general analytical and learning principles for teaching new skills or dealing with problem behaviors. In addition, parents are thought how to adapt activities and demands on the individual child based on his/her cognitive and adaptive abilities. The delivery format of our intervention is also based on well researched components and includes providing psychoeducation; discussions; homework assignments and peer support. Each module last 3 hours and the intervention is given every other week for 8 weeks. Previous interventions: The parenting support group intervention "Everyday life and parenting" consist of four modules. The intervention is theoretically based in social-learning theory and it uses methods from applied behavior analysis, e.g., functional behavior assessment, as well as structured teaching. Three of the intervention modules includes key components from the most effective parenting programs targeting behavior problems in children. Parenting techniques taught during the intervention includes positive parenting skills such as positive reinforcement techniques, relationship enhancement techniques and reframing unhelpful cognitive perceptions about the child. The fourth intervention module is based on theories and knowledge from treatment provided to children with autism and/or intellectual disabilities as well as the ICF framework. Important elements in this module are teaching parents how to organize the physical environment, create activity schedules, visual schedules and/or cues, establish routines with flexibility, and use visually structured activities. These elements create clarity and predictability in everyday life. Furthermore, the module includes teaching parents general analytical and learning principles for teaching new skills or dealing with problem behaviors. In addition, parents are thought how to adapt activities and demands on the individual child based on his/her cognitive and adaptive abilities. The delivery format of our intervention is also based on well researched components and includes providing psychoeducation; discussions; homework assignments and peer support. Each module last 3 hours and the intervention is given every other week for 8 weeks. A computer-generated randomization sequence will be used to assign the participants to a 4-, 7- or 10-week baseline in a 1:1:1 ratio. Block randomization of block sizes 3 or 6 will be generated in a computerized randomization scheme. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 08/11/2024: Questionnaire distributed to parents every week for 15, 18 or 21 weeks, i.e. during baseline phase, intervention and four weeks post intervention: 1. Child behavior problems, questions based on the Eyberg Child Behavior Inventory 2. Parental self-efficacy, the Me As a Parent questionnaire 3. Parents' perceived stress, the Parental Stress Scale Previous primary outcome measure: Questionnaire distributed to parents every week for 16, 19 or 22 weeks, i.e. during baseline phase, intervention and four weeks post intervention: 1. Child behavior problems, questions based on the Eyberg Child Behavior Inventory 2. Parental self-efficacy, the Me As a Parent questionnaire 3. Parents' perceived stress, the Parental Stress Scale |
| Secondary outcome measures | Current secondary outcome measure as of 08/11/2024: Measured at pre-, post and 3-month follow-up, parent's ratings: 1. Child mental health problems, using Strength and Difficulties Questionnaire 2. Parental self-efficacy, using Me As a Parent 3. Parental stress using the Parental Stress Scale 4. Parent's mental health using General health questionnaire, GHQ-12 5. Quality of Life, using Assessing Quality of Life 8 Dimensions (AQOL-8D) 6. Costs related to consumption of societal resources, Trimbos/iMTA questionnaire (TIC-P) 7. Costs related to healthcare consumption using data from child medical records on the number of healthcare visits, prescribed drugs, referrals etc. Measured weekly during 15, 18 or 21 weeks: 8. Children's positive and negative experiences of family life using 5 questions developed for this study Previous secondary outcome measure: Measured at pre-, post and 3-month follow-up, parent's ratings: 1. Child mental health problems, using Strength and Difficulties Questionnaire 2. Parental self-efficacy, using Me As a Parent 3. Parental stress using the Parental Stress Scale 4. Parent's mental health using General health questionnaire, GHQ-12 5. Quality of Life, using Assessing Quality of Life 8 Dimensions (AQOL-8D) 6. Costs related to consumption of societal resources, Trimbos/iMTA questionnaire (TIC-P) 7. Costs related to healthcare consumption using data from child medical records on the number of healthcare visits, prescribed drugs, referrals etc. Measured weekly during 16, 19 or 22 weeks: 8. Children's positive and negative experiences of family life using 5 questions developed for this study |
| Overall study start date | 01/01/2024 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 4 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 80 randomised to achieve 54 completed measures accounting for study attrition |
| Key inclusion criteria | 1. Parents of children aged 2 - 6 years old with subclinical levels of NDD and behavioral problems (as assessed by a clinical psychologist) who have been offered and accepted to participate in the parenting intervention Everyday Life and Parenting 2. Parents need to be able to answer questionnaires in Swedish 3. Only one parent from each family will be included (i.e., the father as fathers often are underrepresented and therefore will contribute to a gender balance in the sample) 4. Children aged 4 - 6 years old, who's parent/parents participate in Everyday life and parenting |
| Key exclusion criteria | 1. Parents who cannot answer the questionnaires in Swedish 2. Parents who don't understand the study information or informed consent 3. Children whose parents are excluded based on the above criteria 4. Children below 4 years of age |
| Date of first enrolment | 16/08/2024 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Uppsala
75308
Sweden
Sponsor information
University/education
Husargatan 3
Uppsala
75123
Sweden
| Phone | +46 184716576 |
|---|---|
| registrator@uu.se | |
| Website | https://www.uu.se/en/ |
"ROR" |
https://ror.org/048a87296 |
Hospital/treatment centre
Islandsgatan 2
Uppsala
75308
Sweden
| Phone | +46 186118732 |
|---|---|
| karin.fangstrom@akademiska.se | |
| Website | https://www.uu.se/en/ |
Funders
Funder type
Research council
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results to be published in peer reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from dr Karin Fängström (karin.fangstrom@uu.se). |
Editorial Notes
06/03/2025: Sponsor details updated.
08/11/2024: The following changes were made:
1. The study design was changed from "Randomized multiple" to "Multiple" and the secondary study design was changed from "Randomized multiple-baseline single-case experimental design (SCED) across participants with pre- and post-measures and a 3-month follow-up" to "non-randomised".
2. Details of randomization were removed from the interventions.
3. The primary and secondary outcome measures were amended.
16/08/2024: Trial's existence confirmed by The Swedish Ethical Review Authority.
