Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT05657067
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:
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.
Study:
NCT05657067
Study Brief:
Protocol Section:
NCT05657067