Effectiveness and Feasibility of Structured EFFT

NCT ID: NCT05657067

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-26

Study Completion Date

2026-06-30

Brief Summary

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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

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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:

1. no, or less change during the waiting period compared with the treatment phase;
2. gain during the treatment phase;
3. and substantial maintenance during follow-up. Hypotheses will be tested with multi-level analyses. Feasibility will be explored.

Conditions

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Emotion Regulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Emotionally Focused Family Therapy (EFFT)

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

Group Type EXPERIMENTAL

Emotionally Focused Family Therapy (EFFT)

Intervention Type BEHAVIORAL

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.

Interventions

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Emotionally Focused Family Therapy (EFFT)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

For this pilot study we will include families with

1. adolescents aged 12-18 years (the so called 'identified' patient), and
2. families coping with mild problems.

Exclusion Criteria

The latter means that we will exclude:

1. blended families because of the more complex loyalties that exist between children and stepparents,
2. families of which individual members cope with serious trauma such as sexual and physical abuse and severe neglect, and
3. families of which the parents or children are diagnosed with severe DSM disorders (substance abuse or psychosis).
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Utrecht University

OTHER

Sponsor Role collaborator

VU University of Amsterdam

OTHER

Sponsor Role lead

Responsible Party

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Henk Jan Conradi

PhD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Psychologiepraktijk Lenny Rodenbrug

Bussum, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Henk Jan Conradi, PhD

Role: CONTACT

+31(0)205258606

Facility Contacts

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Lenny Rodenburg, MSc

Role: primary

0031645663281

References

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Conradi HJ, Meuwese D, Rodenburg L, Dingemanse P, Mooren T. Effectiveness and feasibility of structured emotionally focused family therapy for parents and adolescents: Protocol of a within-subjects pilot study. PLoS One. 2023 Jun 23;18(6):e0287472. doi: 10.1371/journal.pone.0287472. eCollection 2023.

Reference Type DERIVED
PMID: 37352284 (View on PubMed)

Related Links

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https://osf.io/39dt2/

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.

Other Identifiers

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2022-CP-15102

Identifier Type: OTHER

Identifier Source: secondary_id

2022-CP-15102

Identifier Type: -

Identifier Source: org_study_id

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