Psychiatric ProblemNCT04763720
Implementing Dyadic Developmental Psychotherapy (DDP) - Evaluation Research
An observational study of Psychiatric Problem and Child Neglect, run by Sykehuset Telemark at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Psychiatric Problem, Child Neglect, Maltreatment
- What is being tested?
- Dyadic Developmental Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2021to 29 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Families receiving DDP treatment at any of the centra, that fulfill the eligibility criteria.
Who may be able to join
- Symptoms of relational and/or attachment difficulties
- History of trauma, including neglect or emotional abuse
- Age 5-18
- Can understand and make oneself understood in Norwegian
- Trained in DDP
- Working with DDP in either of the centra
Who cannot join
- Current substance abuse in child or caregiver
- Current psychosis in child or caregiver
- Intellectual disability in caregiver Variables that will be tracked but that are not grounds for exclusion are diagnostic variables, including the presence of autism-spectrum disorders, and care-level.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of Dyadic Developmental Psychotherapy for Children and Their Families in an Outpatient Setting.
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.
Read more
The research aims are divided in three research questions:
Q1: What changes are associated with DDP treatment:
Q1.1 the quality of the caregiver-child interaction Q1.2 parental self-efficacy Q1.3 parental stress, Q1.4 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
Read the 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 (DDP),where dyad refers to the unit of a child and its caregiver(s).
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 success.The 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
- Conditions
- Psychiatric Problem, Child Neglect, Maltreatment, Child Behavior Problem, DDP
- Being tested
- Dyadic Developmental Psychotherapy
- Keywords
- Attachment, Dyadic Developmental Psychotherapy, Trauma, Therapy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Developmental PsychotherapyBehavioural
Also called DDP
DDP involves approximately twenty sessions with the family, conducted by a trained DDP therapist. DDP is developed to treat trauma-related and attachment difficulties. DDP is not a manualized treatment but involves using a set of core communication techniques (termed PACE; Playfulness, Acceptance, Curiosity and Empathy).
| Study group | Role | What they receive |
|---|---|---|
| Dyadic Developmental Psychotherapy | Families being treated with DDP at either of the centres Receives: Behavioral: Dyadic Developmental Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of caregiver-child interaction
The quality of caregiver-child interaction using the "Emotional Availability Scales". Max total score is 29 and a higher score means better quality interaction.
Measured: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Secondary outcomes (4)
Change in measured parental self-efficacy
Measure of change in parental self-efficacy/competency as measured by the "Parenting Sense of Competence" scale. Max score 96, higher score indicates higher perceived competence.
Measured: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Change in parental stress
Measure of change in parental stress as measured by the "Parental Stress Scale". Max score is 90 and a higher score indicates higher parental stress.
Measured: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Change in child symptoms of traumatic stress
Measure of child's symptoms of traumatic stress as measured by "Child and Adolescent Trauma Screening". Max score is 60, higher score indicates higher levels of traumatic stress.
Measured: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Change in child emotional and behavioral symptoms
General screening of child's symptoms of emotional and behavioral problems, as measured by the "ASEBA" (Achenbach System of Empirically Based Assessment) Child Behavior Checklist. ASEBA uses standardized scores according to age-specific norms, where higher t-scores indicates more/stronger symptoms on each subscale.
Measured: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2021
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Idun Røseth, Ph.D, Principal investigator, Telemark Hospital Trust - University of South-East Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763720
- Sponsor's protocol ID
- 75120X
- Status last verified
- Jul 2025
- First submitted
- 2 Feb 2021
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Becker-Weidman A. Treatment for Children with Reactive Attachment Disorder: Dyadic Developmental Psychotherapy. Child Adolesc Ment Health. 2008 Feb;13(1):52. doi: 10.1111/j.1475-3588.2006.00428.x. No abstract available.
PubMed 32847154
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Dyadic Developmental Psychotherapy for Children and Their Families in an Outpatient Setting.
- ClinicalTrials.gov ID
- NCT04763720
- Acronym / sponsor ID
- 75120X
- Conditions
- Psychiatric Problem, Child Neglect, Maltreatment, Child Behavior Problem, DDP
- Keywords
- Attachment, Dyadic Developmental Psychotherapy, Trauma, Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Q1.1 the quality of the caregiver-child interaction Q1.2 parental self-efficacy Q1.3 parental stress, Q1.4 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 (DDP),where dyad refers to the unit of a child and its caregiver(s).
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 success.The 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyadic Developmental Psychotherapy | – | Behavioral: Dyadic Developmental PsychotherapyFamilies being treated with DDP at either of the centres |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families receiving DDP treatment at any of the centra, that fulfill the eligibility criteria.
Key inclusion criteria (6 listed)
- Symptoms of relational and/or attachment difficulties
- History of trauma, including neglect or emotional abuse
- Age 5-18
- Can understand and make oneself understood in Norwegian
- Trained in DDP
Key exclusion criteria (3 listed)
- Current substance abuse in child or caregiver
- Current psychosis in child or caregiver
- Intellectual disability in caregiver Variables that will be tracked but that are not grounds for exclusion are diagnostic variables, including the presence of autism-spectrum disorders, and care-level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Developmental PsychotherapyAlso: DDPDDP involves approximately twenty sessions with the family, conducted by a trained DDP therapist. DDP is developed to treat trauma-related and attachment difficulties. DDP is not a manualized treatment but involves using a set of core communication techniques (termed PACE; Playfulness, Acceptance, Curiosity and Empathy). | Behavioural | Dyadic Developmental Psychotherapy |
Primary outcome
Change in quality of caregiver-child interaction
Time frame: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
The quality of caregiver-child interaction using the "Emotional Availability Scales". Max total score is 29 and a higher score means better quality interaction.
4 secondary outcomes
Change in measured parental self-efficacy
Time frame: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Change in parental stress
Time frame: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Change in child symptoms of traumatic stress
Time frame: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Change in child emotional and behavioral symptoms
Time frame: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 32847154Becker-Weidman A. Treatment for Children with Reactive Attachment Disorder: Dyadic Developmental Psychotherapy. Child Adolesc Ment Health. 2008 Feb;13(1):52. doi: 10.1111/j.1475-3588.2006.00428.x. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Idun Røseth, Ph.D principal investigator
Telemark Hospital Trust - University of South-East Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Problem and Child Neglect, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of caregiver-child interaction (time frame: Time 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.