All Children in Focus (ABC) 0-2 Years: A Pilot Study | NCT06037642

Studies
All Children in Focus (ABC) 0-2 Years: A Pilot Study

NCT06037642

Sponsor

Ersta Sköndal University College

Status

Completed

Last Update Posted

Sep 14, 2023Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Parent-Child Relations
Parenting

Interventions

ABC 0-2 years
waiting list

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2023

Last Update Posted Date

Sep 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anders Kassman, Associate professor, Ersta Sköndal University CollegePrincipal Investigator

Lead Sponsor

Ersta Sköndal University CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare parents tools to handle challenges and strengths as parents. The main questions it aims to answer are:

Do participating parents feel more confident than non partipating parents?
Does the program have positive effects on parenting practices, parents´ well-being, and social support?
Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis status)

Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes optional coffe break. In addition parents will be asked to do homework assignments between the sessions.

Researchers will compare the intervention group with an equally sized control group that will receive the program later the same year.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental		Behavioral: ABC 0-2 years
Control group	Active Comparator		Other: waiting list

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABC 0-2 years	Behavioral	Four 1 hour meetings and homework	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parents´self efficacy	Questionnaire	Four weeks
Parenting practices and parent child relationship	Questionnaire	Four weeks
Parents´involvement and warmth	Questionnaire	Four weeks
Parents´ well-being	Questionnaire	Four weeks
Parents´ social network	Questionnaire	Four weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents to children aged 0-2 years

Exclusion Criteria:

Non fluent in Swedish language

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Eriksson, Phd	Ersta Sköndal University College	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PLUS		Stockholm			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C106538	abacavir
D014850	Waiting Lists

Ancestor Terms

ID	Term
D001071	Appointments and Schedules
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided