NCT04763720

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: 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Jan 2021Feb 2028

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

7.2 years

First QC Date

February 2, 2021

Last Update Submit

July 3, 2025

Conditions

Keywords

AttachmentDyadic Developmental PsychotherapyTraumaTherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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 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 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 1 is when the family is referred to DDP treatment, time 2 when treatment is finished, approximately 24 weeks later

Other Outcomes (2)

  • Caregiver's experience of receiving DDP

    Approximately 24 weeks after the family has been referred to DDP treatment

  • Therapists experience of the implementation and use of DDP

    Up to every 3rd month after the therapist has been trained in DDP, until the end of the data collection period (31.12.2023)

Study Arms (1)

Dyadic Developmental Psychotherapy

Families being treated with DDP at either of the centres

Behavioral: Dyadic Developmental Psychotherapy

Interventions

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).

Also known as: DDP
Dyadic Developmental Psychotherapy

Eligibility Criteria

Age5 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Families receiving DDP treatment at any of the centra, that fulfill the eligibility criteria.

You may qualify if:

  • 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

You may not qualify if:

  • Current substance abuse in child or caregiver
  • Current psychosis in child or caregiver
  • Trained in DDP
  • Working with DDP in either of the centra

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Telemark Hospital Trust

Skien, Vestfold Og Telemark, 3710, Norway

Location

Related Publications (1)

  • 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.

    PMID: 32847154BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Idun Røseth, Ph.D

    Telemark Hospital Trust - University of South-East Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 21, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations