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Effectiveness and Feasibility of Structured EFFT

Primary Purpose

Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Emotionally Focused Family Therapy (EFFT)
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotion Regulation focused on measuring Attachment, Adolescents, Family, Mental Health Problems, Emotionally Focused Family Therapy (EFFT)

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: For this pilot study we will include families with adolescents aged 12-18 years (the so called 'identified' patient), and families coping with mild problems. Exclusion criteria: The latter means that we will exclude: blended families because of the more complex loyalties that exist between children and stepparents, families of which individual members cope with serious trauma such as sexual and physical abuse and severe neglect, and families of which the parents or children are diagnosed with severe DSM disorders (substance abuse or psychosis).

Sites / Locations

  • Psychologiepraktijk Lenny RodenbrugRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Emotionally Focused Family Therapy (EFFT)

Arm Description

For this pilot study we aim for 15-20 included families who will be treated by three to five family therapists.

Outcomes

Primary Outcome Measures

Change from the waiting period in Negative interaction patterns on the Relationship Dynamics Scale (RDS; Stanley et al., 2001) during and after EFFT.
The RDS is a validated self-reported 4 item questionnaire assessing negative interaction patterns over the past 2 weeks. Possible total scores range from 4 (negligible) to 16 (often). Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Change from the waiting period in Accessibility and responsiveness of the attachment figures on the Accessibility, Responsiveness, Emotional Engagement questionnaire (ARE; Johnson, 2008).
The ARE is a validated self-reported 6 item questionnaire assessing accessibility and responsiveness of the attachment figures over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Change from the waiting period in Discipline on the Discipline subscale of the Self-Efficacy for Parenting Tasks Index Toddler Scale (SEPTI; Coleman & Karraker, 2003).
The Discipline 7 item subscale is part of the SEPTI a validated self-reported questionnaire assessing displine of the children by their partners over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Change from the waiting period in Attachment between parents and adolescent and the parents as partners on the Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS; Fraley et al., 2011)
The ECR is a validated self-reported 9 item questionnaire assessing Anxiety about rejection and abandonment and Avoidance of intimacy. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Change from the waiting period in Relationship satisfaction between the parents as partners on the Couple Satisfaction Index (CSI; Funk & Rogge, 2007).
The CSI is a validated self-reported 4 item questionnaire assessing relationship satisfaction over the past week. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Change from the waiting period in the adolescent's Complaints on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).
The SDQ is a validated self-reported 20 item questionnaire assessing adolescent's Complaints over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.

Secondary Outcome Measures

Feasibility of structured EFFT.
Feasibility will be assessed by semi-structured interviews.

Full Information

First Posted
November 27, 2022
Last Updated
December 9, 2022
Sponsor
VU University of Amsterdam
Collaborators
Utrecht University
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1. Study Identification

Unique Protocol Identification Number
NCT05657067
Brief Title
Effectiveness and Feasibility of Structured EFFT
Official Title
Effectiveness and Feasibility of Structured Emotionally Focused Family Therapy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam
Collaborators
Utrecht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical pilot study is to assess effectiveness and feasilibity of structured Emotionally Focused Family Therapy (EFFT) for parents and adolescents. Participants will fill out questionnaires before, during and after the EFFT treatment Finally, feasibility will be assessed by semi-structured interviews.
Detailed Description
Background The prevalence of mental health problems of children and adolescents worldwide is substantial with 10-20%. Attachment related emotion regulation is considered an important transdiagnostic process underlying mental health problems in adolescents. Emotionally Focused Family Therapy (EFFT) aims at the development of secure attachment between parents and their children in order to reduce the child's vulnerability for mental health problems and enhance resilience. Intervention The current pilot study is a first test of the newly developed protocol of structured EFFT. It consists of 4 phases and 16-21 sessions: phase 1 (1-2 sessions with the whole family) reframing the individual adolescent's problem as related to insecure attachment relations with the parents; phase 2A (4-6 sessions with the parents) and phase 2B (3 sessions with the adolescent) are delivered in parallel fashion and aim to prepare them to phase 3 by exploring insecure attachment relations and unfulfilled attachment needs; phase 3 (3 sessions with parents and adolescent) is focused on development of secure attachment relations between parents and adolescent; phase 4 (3 sessions with the whole family) consolidation of secure attachment and additional interventions for residual psychopathology; and finally a booster session with the whole family. Treatment adherence will be assessed with a check list by independent raters of sound recordings of random sessions. Design and method A within-subjects design, without randomized control group, with three waves will be applied: (1) waiting period of 2 months, (2) treatment phase 3-4 months, and (3) 2 months follow-up period concluded with a booster session. Comparing change during the waiting period vs. change during treatment will provide a clear indication of spontaneous remission vs. treatment-related change. The study will use a multi-method approach: quantitative for the effectiveness part (multilevel analyses of questionnaires) and qualitative for the feasibility part (semi-structured interviews). Treatment adherence will be assessed with sound recording of random sessions. Hypotheses Concerning the effectiveness of structured EFFT the researchers anticipate that, if limited power of this pilot study yields significant differences, outcomes will show: no, or less change during the waiting period compared with the treatment phase; gain during the treatment phase; and substantial maintenance during follow-up. Hypotheses will be tested with multi-level analyses. Feasibility will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotion Regulation
Keywords
Attachment, Adolescents, Family, Mental Health Problems, Emotionally Focused Family Therapy (EFFT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emotionally Focused Family Therapy (EFFT)
Arm Type
Experimental
Arm Description
For this pilot study we aim for 15-20 included families who will be treated by three to five family therapists.
Intervention Type
Behavioral
Intervention Name(s)
Emotionally Focused Family Therapy (EFFT)
Intervention Description
The rationale behind EFFT is that mental health problems in children and adolescents often originate and/or are exacerbated by negative interaction patterns rooted in insecure attachment bonds within families. Therefore, the main treatment goal of EFFT is the development of secure attachment between parents and their children.
Primary Outcome Measure Information:
Title
Change from the waiting period in Negative interaction patterns on the Relationship Dynamics Scale (RDS; Stanley et al., 2001) during and after EFFT.
Description
The RDS is a validated self-reported 4 item questionnaire assessing negative interaction patterns over the past 2 weeks. Possible total scores range from 4 (negligible) to 16 (often). Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Time Frame
Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)
Title
Change from the waiting period in Accessibility and responsiveness of the attachment figures on the Accessibility, Responsiveness, Emotional Engagement questionnaire (ARE; Johnson, 2008).
Description
The ARE is a validated self-reported 6 item questionnaire assessing accessibility and responsiveness of the attachment figures over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Time Frame
Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)
Title
Change from the waiting period in Discipline on the Discipline subscale of the Self-Efficacy for Parenting Tasks Index Toddler Scale (SEPTI; Coleman & Karraker, 2003).
Description
The Discipline 7 item subscale is part of the SEPTI a validated self-reported questionnaire assessing displine of the children by their partners over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Time Frame
Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)
Title
Change from the waiting period in Attachment between parents and adolescent and the parents as partners on the Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS; Fraley et al., 2011)
Description
The ECR is a validated self-reported 9 item questionnaire assessing Anxiety about rejection and abandonment and Avoidance of intimacy. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Time Frame
Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)
Title
Change from the waiting period in Relationship satisfaction between the parents as partners on the Couple Satisfaction Index (CSI; Funk & Rogge, 2007).
Description
The CSI is a validated self-reported 4 item questionnaire assessing relationship satisfaction over the past week. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Time Frame
Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)
Title
Change from the waiting period in the adolescent's Complaints on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).
Description
The SDQ is a validated self-reported 20 item questionnaire assessing adolescent's Complaints over the past month. Change will be assessed for: the waiting period (pre-treatment score - pre waiting period score), during EFFT (post treatment - pre treatment), during follow up (pre-booster session score - post -treatment score) and over the total study period.
Time Frame
Through study completion, an average of 1 year per family: t1 = pre-waiting period; t2 = pre-treatment; t3 = pre-phase 3 (after 5-8 sessions); t4 = post treatment (after 16-21 sessions), t5 = pre-booster session (two months after final session)
Secondary Outcome Measure Information:
Title
Feasibility of structured EFFT.
Description
Feasibility will be assessed by semi-structured interviews.
Time Frame
Two months after the final session, after the booster session has taken place. Semi-structured interviews will take place with the adolescent being interviewed separately from his or her parents.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: For this pilot study we will include families with adolescents aged 12-18 years (the so called 'identified' patient), and families coping with mild problems. Exclusion criteria: The latter means that we will exclude: blended families because of the more complex loyalties that exist between children and stepparents, families of which individual members cope with serious trauma such as sexual and physical abuse and severe neglect, and families of which the parents or children are diagnosed with severe DSM disorders (substance abuse or psychosis).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henk Jan Conradi, PhD
Phone
+31(0)205258606
Email
h.j.conradi@uva.nl
Facility Information:
Facility Name
Psychologiepraktijk Lenny Rodenbrug
City
Bussum
ZIP/Postal Code
1402BD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lenny Rodenburg, MSc
Phone
0031645663281
Email
info@lennyrodenburg.nl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data management The data will be saved under administration numbers to which each family member is linked and stored on the protected ICT environment of the University of Amsterdam. The data analysis will be performed at the University of Amsterdam. Personal data will be handled conform the General Data Protection Regulation.
Links:
URL
https://osf.io/39dt2/
Description
This is the preregistration at the Open Science Framework which was published before recruitment commenced. The study protocol described at OSF is identical to the one provided here.

Learn more about this trial

Effectiveness and Feasibility of Structured EFFT

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