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Completed

NCT Number: NCT03351582

Grief and Communication Family Intervention

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.

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Key information

Conditions

Grief Behavior Communication Personal Satisfaction Psychological Well-Being

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private clinic

Stockholm, Sweden

About this study

The intervention study will test a supportive family therapy intervention for families where a parent has died from cancer between 2013 and 2015. This will be a randomized controlled trial where participants are assigned to one of three groups using a random number sequence generated by a computer program with approximately 25 families in each intervention group.

Group one will meet with a family therapist for one 90 minute session where the main focus will be on providing information through psychoeducation on grief and communication to participants.

Group two will participate in a family therapy intervention comprised of three 90 minute sessions. participants will receive the same psychoeducation as group one and will also work with the family therapist to enhance family communication and process their grief. The 3 sessions are manual based.

Group three will be the control group and will not meet with a family therapist.

Participants will be asked if their sessions with the family therapist can be tape-recorded, but do not have to consent to this in order to participate. Approximately 6 participants need to be recorded in order to ensure that the family therapists are covering the same topics and giving the same information to all participants. In this way we can ensure that the method of intervention is the same no matter which therapist is delivering the intervention thereby validating the method of intervention.

Follow up will occur 1 month and 6 months after the intervention has ended. Each participant will fill in a short questionnaire regarding grief and Communication. Validated instruments will also be included in the questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Grief and Communication Family Intervention

Behavioral

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

Primary outcomes

  1. Parent-Adolescent Communication Scale

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

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

Secondary outcomes

  1. The Prolonged Grief Disorder Inventory PG-13

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

    questionnaire- scores range between 11-55 higher scores indicate more symptoms of prolonged grief

  2. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

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

    questionnaire-The items are rated on a 5-point scale with response descriptors 0 ''not at all'' to 4 ''extremely''. Total scores range from 0 to 80 and a preliminary cut-off score of 33 is suggested as indicating PTSD

  3. Montgomery-Åsberg Depression Rating Scale

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

    questionnaire-The MADRS was used to assess symptoms of depression. It consists of 9 items. Each item is scored on a 6-point Likert scale. The total score is calculated by summing the answers of the nine items, ranging between 0 and 54 and a higher score indicates a greater risk of depression. Cut off is usually put at 10 for mild depression, 20 for moderate depression and >34 for severe depression

  4. The Generalized Anxiety Disorder scale (GAD-7)

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

    The GAD-7 was used to assess symptoms of anxiety. It consists of 7 items, scored on a 4-point scale to the response categories from "not at all" to "nearly every day", and adding together the scores for the seven questions. Total scores of 5, 10, and 15 are taken as the cut-off for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or more

  5. The Strengths and Difficulties Questionnaire (SDQ)

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

    questionnaire- subscale externalizing symptoms scores range from 0-20 with higher scores indicating more internalizing problems. Externalizing subscale scores range from 0-20 with higher scores indicating more externalizing problems.

  6. Trauma cognitions checklist

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

    Parent report of children's PTSD symptoms. Scores range from 9-27 with higher scores indicating more PTSD symptoms

  7. Rosenberg self-esteem scale

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

    questionnaire- scores range between 10-40 with higher scores indicating higher self-esteem

Sponsors and collaborators

Lead sponsor

Ersta Sköndal University College

Other

Registry information

Official study title

Family Support for Grief and Communication

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2017
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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