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

Sponsor

Ersta Sköndal University College (Other)

Overall Status

Completed

CT.gov ID

NCT06037642

Collaborator

(none)

300

Enrollment

Location

Arms

4.9

Actual Duration (Months)

61.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parent-Child Relations Parenting	Behavioral: ABC 0-2 years Other: waiting list	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Actual Primary Completion Date :

Jun 30, 2023

Actual Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group	Behavioral: ABC 0-2 years Four 1 hour meetings and homework
Active Comparator: Control group	Other: waiting list Will be put on hold for four weeks

Arm

Intervention/Treatment

Experimental: Intervention group

Behavioral: ABC 0-2 years

Four 1 hour meetings and homework

Active Comparator: Control group

Other: waiting list

Will be put on hold for four weeks

Outcome Measures

Primary Outcome Measures

Parents´self efficacy [Four weeks]
Questionnaire
Parenting practices and parent child relationship [Four weeks]
Questionnaire
Parents´involvement and warmth [Four weeks]
Questionnaire
Parents´ well-being [Four weeks]
Questionnaire
Parents´ social network [Four weeks]
Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Parents to children aged 0-2 years

Exclusion Criteria:

Non fluent in Swedish language

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PLUS	Stockholm		Sweden

Sponsors and Collaborators

Ersta Sköndal University College

Investigators

Study Director: Maria Eriksson, Phd, Ersta Sköndal University College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders Kassman, Associate professor, Ersta Sköndal University College

ClinicalTrials.gov Identifier:

NCT06037642

Other Study ID Numbers:

All children in focus

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anders Kassman, Associate professor, Ersta Sköndal University College

Parenting support

Study Results

No Results Posted as of Sep 14, 2023