NCT04101799

Brief Summary

Evaluation of the effects of the parental support intervention "For our children's sake" on positive parenting outcomes when conducted with incarcerated parents in prisons in Sweden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 20, 2019

Last Update Submit

September 22, 2020

Conditions

Keywords

PrisonCriminalityChild

Outcome Measures

Primary Outcomes (1)

  • 7-items sub-scale Closeness in the Child Parent Relationship Scale

    Parent-reported quality in relationship between parent and child on a 5-point scale ('complete agree' to 'completely disagree')

    Positive change in mean score of all 7 items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.

Secondary Outcomes (3)

  • Contact frequency and type between parent and child

    Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.

  • Eight items chosen from the sub-scale antisocial intent in the Measures of Criminal Attitudes and Associates scale

    Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.

  • Parent interest in other treatment programmes in prison

    Change in item score between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at a 3-month post intervention follow-up.

Other Outcomes (2)

  • 14 item parenting attitude from the The Adult-Adolescent Parenting Inventory (AAPI-2)

    Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.

  • 6 items parental self-efficacy scale

    Change in mean score of items between baseline (pre-intervention) and end of intervention, after 10 weeks. Measurements will also be conducted at mid-intervention to investigate mediated effects, and a 3-month post intervention follow-up.

Study Arms (2)

Intervention

EXPERIMENTAL

Participating in the For our children's sake intervention, 10 group sessions, 2 hours each

Behavioral: For Our Children's Sake

Control

ACTIVE COMPARATOR

Participating in everyday activities that may include parenting activities in the control prisons

Other: Active control

Interventions

Parental support with the aim to support positive parenting and promote healthy child development. Conducted in group-format with weekly 2.hour sessions conducted by trained group leaders according to a programme manual.

Intervention

Participating in everyday activities that may include parenting activities in the control prisons

Control

Eligibility Criteria

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

You may qualify if:

  • Serving a sentence at any of the included prisons
  • Having at least one child in the ages between 0-18 years. Parents of children aged 0-2 and 13-18 years will not be included in the primary outcome measure, as the measure is not developed for these age groups. These parents will be included in the mediator measurements.
  • Are in contact with their child/children in any form. If not, these parents are included in the mediator measurements, as the primary outcome: relationship quality, is not applicable.
  • Having the legal right to contact the child
  • Not committed either a crime against the child or any violent crime against the other parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (2)

  • Norman A, Enebrink P. Effects of a parental support intervention for parents in prison on child-parent relationship and criminal attitude-The For Our Children's Sake pragmatic controlled study. PLoS One. 2023 Mar 23;18(3):e0283177. doi: 10.1371/journal.pone.0283177. eCollection 2023.

  • Norman A, Enebrink P. Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial. BMJ Open. 2020 Jun 7;10(6):e034834. doi: 10.1136/bmjopen-2019-034834.

MeSH Terms

Conditions

Criminal Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Åsa Norman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 24, 2019

Study Start

September 21, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Data cannot be shared publicly because of ethical reasons, where public availability would compromise participant privacy. Data are available from the Department of Clinical Neuroscience, Karolinska Institute (contact via registrator@cns.ki.se) for researchers who meet the criteria for access to confidential data.

Shared Documents
STUDY PROTOCOL
Time Frame
After article publication
Access Criteria
Data cannot be shared publicly because of ethical reasons, where public availability would compromise participant privacy. Data are available from the Department of Clinical Neuroscience, Karolinska Institute (contact via registrator@cns.ki.se) for researchers who meet the criteria for access to confidential data.

Locations