NCT06037642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 7, 2023

Last Update Submit

September 7, 2023

Conditions

Parent-Child RelationsParenting

Keywords

Parenting support

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: ABC 0-2 years

Control group

ACTIVE COMPARATOR
Other: waiting list

Interventions

ABC 0-2 yearsBEHAVIORAL

Four 1 hour meetings and homework

Intervention group
waiting listOTHER

Will be put on hold for four weeks

Control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents to children aged 0-2 years

You may not qualify if:

  • Non fluent in Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLUS

Stockholm, Sweden

Location

MeSH Terms

Interventions

abacavirWaiting Lists

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Maria Eriksson, Phd

    Ersta Sköndal University College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

February 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)