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Effectiveness and Feasibility of Structured EFFT

V

VU University of Amsterdam

Status

Enrolling

Conditions

Emotion Regulation

Treatments

Behavioral: Emotionally Focused Family Therapy (EFFT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05657067
2022-CP-15102 (Other Identifier)

Details and patient eligibility

About

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.

Full 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:

  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.

Enrollment

15 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Emotionally Focused Family Therapy (EFFT)
Experimental group
Description:
For this pilot study we aim for 15-20 included families who will be treated by three to five family therapists.
Treatment:
Behavioral: Emotionally Focused Family Therapy (EFFT)

Trial contacts and locations

1

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Central trial contact

Henk Jan Conradi, PhD

Data sourced from clinicaltrials.gov

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