NCT03351582

Brief Summary

The overall purpose of this project is to evaluate the effects of a family therapy intervention for grieving families with children. The main outcome variable is family communication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration 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

November 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

November 14, 2017

Last Update Submit

August 11, 2020

Conditions

Keywords

family therapypsychological health

Outcome Measures

Primary Outcomes (1)

  • Parent-Adolescent Communication Scale

    questionnaire- scores between 20-100 with higher scores indicating better family communication.

    Change from baseline score at one month, six month, and 18 month follow up

Secondary Outcomes (7)

  • The Prolonged Grief Disorder Inventory PG-13

    Change from baseline score at one month, six month, and 18 month follow up

  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Change from baseline score at one month, six month, and 18 month follow up

  • Montgomery-Åsberg Depression Rating Scale

    Change from baseline score at one month, six month, and 18 month follow up

  • The Generalized Anxiety Disorder scale (GAD-7)

    Change from baseline score at one month, six month, and 18 month follow up

  • The Strengths and Difficulties Questionnaire (SDQ)

    Change from baseline score at one month, six month, and 18 month follow up

  • +2 more secondary outcomes

Study Arms (3)

Grief and Communication One Session

EXPERIMENTAL

Group one will meet with a family therapist for one 90 minute session where the main focus will be on providing psychoeducation on grief and communication to both children and parents. This arm receives only the first session of the grief and communication family intervention.

Behavioral: Grief and Communication Family Intervention

Grief and Communication Three Sessions

EXPERIMENTAL

Thie Group will receive all three sessions of the grief and communication family intervention.

Behavioral: Grief and Communication Family Intervention

Control

NO INTERVENTION

Group three will be the control group and will not receive the grief and communication family intervention.

Interventions

This intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy.

Grief and Communication One SessionGrief and Communication Three Sessions

Eligibility Criteria

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

You may qualify if:

  • Participants are families with Children ages 3-19 who have completed our questionnaire study and have responses indicating that one or more family members have symptoms of complicated grief or a negative pattern of communication within the family. All family members who live in the same home may participate in the family therapy intervention including new partners or step children. It is up to the family to decide which family members will be included.

You may not qualify if:

  • Participants must reside in Stockholm, Sweden during data collection, speak and understand written and spoken Swedish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private clinic

Stockholm, Sweden

Location

MeSH Terms

Conditions

CommunicationPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Officials

  • Josefin Sveen, PhD

    Ersta Sköndal University College

    PRINCIPAL INVESTIGATOR

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 in medical psychology

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 24, 2017

Study Start

January 15, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations