NCT03901027

Brief Summary

Purpose: A growing number of families with children are dealing with chronic illnesses or health problems that places increased demand on the family. Nurses are in a core position to support and empower these families. The benefit of therapeutic conversation between nurses and families dealing with health problems have shown positive results and therefore received increasing attention. The aim of this study was to evaluate the benefits of two sessions of the Family Strength Oriented Therapeutic Conversation (FAM-SOTC) intervention, offered by advanced practice nurses (APN), for parents of children and adolescents with Juvenile idiopathic arthritis (JIA), epilepsy, diabetes, and with sleep disturbance with attention deficit hyperactivity disorder (ADHD). Design: The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design. Method: The intervention was based on the Calgary family assessment and intervention models and the Illness Beliefs model and was offered in March 2015--December 2016. Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

March 20, 2019

Last Update Submit

April 4, 2019

Conditions

Keywords

ParentsChildrenChronic Illnesses

Outcome Measures

Primary Outcomes (4)

  • The ICE-Perceived Family Support from nurses Questionnaire (14-Items) at baseline

    Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 14-70, with higher score indicating better outcome.

    1 week

  • The ICE-Perceived Family Support from nurses Questionnaire (14-Items)

    Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale scores range from 14-70, with higher score indicating better outcome.

    8-10 weeks

  • The ICE-Family Illness Beliefs Questionnaire (7-Items) at baseline

    I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 7-35, with higher score indicating better outcome.

    1 week

  • The ICE-Family Illness Beliefs Questionnaire (7-Items)

    I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5.

    8-10 weeks The total scale score range from 7-35, with higher score indicating better outcome.

Secondary Outcomes (4)

  • the PedsQL-Family Impact Module (36-item) at baseline

    1 week

  • the PedsQL-Family Impact Module (36-item)

    8-10 weeks

  • The PedsQL-Healthcare Satisfaction Generic Module (24-items) at baseline

    1 week

  • The PedsQL-Healthcare Satisfaction Generic Module (24-items)

    8-10 weeks

Study Arms (1)

Parents of children with chronic illnesses

EXPERIMENTAL

psycho-educational intervention for parents

Behavioral: Therapeutic Conversation Interventions

Interventions

Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members. The parents meet with the Advanced Practice Nurse at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval.

Parents of children with chronic illnesses

Eligibility Criteria

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

You may qualify if:

  • Being a parents of children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD who were in active treatment at a University Hospital.
  • Parents needed to be fluent in the Icelandic language.

You may not qualify if:

  • Parents who did not understand Icelandic or English.
  • Parents who could not read or write at the 4th grade level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ása Þórisdóttir

    University of Iceland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

April 3, 2019

Study Start

March 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share