Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04763720
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-18
First Post:
2021-02-02
Brief Title:
Implementing Dyadic Developmental Psychotherapy DDP - Evaluation Research
Sponsor:
Sykehuset Telemark
Organization:
Sykehuset Telemark
Study Overview
Official Title:
Implementation of Dyadic Developmental Psychotherapy for Children and Their Families in an Outpatient Setting
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the implementation and use of Dyadic Developmental Psychotherapy DDP in three centra with particular focus on its potential effects on the quality of the observable caregiver-child interaction The three centra included are Telemark Hospital Trust Department for Child- and Adolescent Psychiatric Health Child Protective Services in Skien and Child Protective Services in Porsgrunn The implementation of DDP is being led by Telemark Hospital Trust while therapists from all centra are being trained in DDP as part of the implementation process
Primarily we aim to identify any changes associated with DDP treatment in the caregiver-child interaction as measured by the Emotional Availability Scales EA scales Our secondary outcome measures assess changes in parental self-efficacy parental stress and child emotional and behavioral problems
The research aims are divided in three research questions
Q1 What changes are associated with DDP treatment
Q11 the quality of the caregiver-child interaction Q12 parental self-efficacy Q13 parental stress Q14 child emotional and behavioral problems Based on previous literature we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment and a decrease in parental stress and child emotional and behavioral problems Becker-Weidman A 2006
In addition to assessing the effects of DDP we will evaluate the implementation of DDP in the three centra and inform the implementation by collecting information through interviews with patients and clinicians We aim to answer
Q2 How do children and their caregivers experience DDP as a therapeutic intervention Q3 How do clinicians experience the training process and the use of DDP as a therapeutic intervention
Based on previous literature we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment and a decrease in parental stress and child emotional and behavioral problems
Primarily we aim to identify any changes associated with DDP treatment in the caregiver-child interaction as measured by the Emotional Availability Scales EA scales Our secondary outcome measures assess changes in parental self-efficacy parental stress and child emotional and behavioral problems
The research aims are divided in three research questions
Q1 What changes are associated with DDP treatment
Q11 the quality of the caregiver-child interaction Q12 parental self-efficacy Q13 parental stress Q14 child emotional and behavioral problems Based on previous literature we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment and a decrease in parental stress and child emotional and behavioral problems Becker-Weidman A 2006
In addition to assessing the effects of DDP we will evaluate the implementation of DDP in the three centra and inform the implementation by collecting information through interviews with patients and clinicians We aim to answer
Q2 How do children and their caregivers experience DDP as a therapeutic intervention Q3 How do clinicians experience the training process and the use of DDP as a therapeutic intervention
Based on previous literature we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment and a decrease in parental stress and child emotional and behavioral problems
Detailed Description:
Children who have been subject to physical sexual or emotional abuse or neglect are at risk of developing unhealthy relationships with their caregiver increasing the likelihood of them developing a wide range of mental health problems later in life Norway offers few therapeutic programs for treatment of children and adolescents that focus specifically on treating traumatic experiences within attachment relationships An intervention with this focus is Dyadic Developmental Psychotherapy DDPwhere dyad refers to the unit of a child and its caregivers
The Family-Based Treatment Unit SFB within the Division for Child- and Adolescent Mental Health ABUP at Telemark Hospital has started implementing DDP with funding from the BUP Project resulting in a multi-center implementation plan including local child protective services and the office for children youth and family affairs This project seeks to evaluate the implementation of DDP and assess any change in the quality of the caregiver-child interaction parental efficacy parental stress and wellbeing and child emotional and behavioral problems as well as the subjective experience of this implementation among caregivers and clinicians The results of interviews with clinicians and parents will provide feedback guide the implementation and provide essential knowledge about using DDP in a Norwegian setting
Child protective services CPS in the municipalities of Skien and Porsgrunn will be implementing DDP in their respective services and their experiences with the process will also be collected Mixed method assessment will be used to follow the implementation process
The present study will contribute new knowledge of how the intervention is experienced by Norwegian children and their families both in a clinical outpatient setting at Telemark Hospital as well as Skien and Porsgrunn Child Protective Services
Clinicians experiences with the implementation and use of DDP is an important dimension for its successThe project will report on what challenges arose during implementation in Norway and how both families and clinicians experienced the process of learning using and receiving DDP By using the information gained directly into the process of this project it can help guide the continued implementation and contribute to its success If DDP is shown to be a positive and helpful therapeutic methods there are plans for a multi-center randomized controlled trial
We will investigate the specific context through participant-observations during project meetings and analyze central documents regarding the implementation and use of DDP
Through working closely with Child Protective Services we will also be able to explore the experiences of implementation of the treatment in different settings
Ethical review has been conducted by the Norwegian South East Regional committee for Medical and Health Research REK as well as the Norwegian Centre for Research Data NSD and the project has been approved The participants will receive full information and be asked to give consent both verbally and in writing They will be assured confidentiality and anonymity They will be informed of their right to withdraw at any time and that it will have no impact on their treatment at ABUP We do not expect this study to cause any harm to participants The observations are part of routine examination of short duration and are conducted within the security of a familiar institution
The Family-Based Treatment Unit SFB within the Division for Child- and Adolescent Mental Health ABUP at Telemark Hospital has started implementing DDP with funding from the BUP Project resulting in a multi-center implementation plan including local child protective services and the office for children youth and family affairs This project seeks to evaluate the implementation of DDP and assess any change in the quality of the caregiver-child interaction parental efficacy parental stress and wellbeing and child emotional and behavioral problems as well as the subjective experience of this implementation among caregivers and clinicians The results of interviews with clinicians and parents will provide feedback guide the implementation and provide essential knowledge about using DDP in a Norwegian setting
Child protective services CPS in the municipalities of Skien and Porsgrunn will be implementing DDP in their respective services and their experiences with the process will also be collected Mixed method assessment will be used to follow the implementation process
The present study will contribute new knowledge of how the intervention is experienced by Norwegian children and their families both in a clinical outpatient setting at Telemark Hospital as well as Skien and Porsgrunn Child Protective Services
Clinicians experiences with the implementation and use of DDP is an important dimension for its successThe project will report on what challenges arose during implementation in Norway and how both families and clinicians experienced the process of learning using and receiving DDP By using the information gained directly into the process of this project it can help guide the continued implementation and contribute to its success If DDP is shown to be a positive and helpful therapeutic methods there are plans for a multi-center randomized controlled trial
We will investigate the specific context through participant-observations during project meetings and analyze central documents regarding the implementation and use of DDP
Through working closely with Child Protective Services we will also be able to explore the experiences of implementation of the treatment in different settings
Ethical review has been conducted by the Norwegian South East Regional committee for Medical and Health Research REK as well as the Norwegian Centre for Research Data NSD and the project has been approved The participants will receive full information and be asked to give consent both verbally and in writing They will be assured confidentiality and anonymity They will be informed of their right to withdraw at any time and that it will have no impact on their treatment at ABUP We do not expect this study to cause any harm to participants The observations are part of routine examination of short duration and are conducted within the security of a familiar institution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None