Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07162493
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ATTACH in Denmark: A Feasibility Randomized Controlled Trial
Sponsor:
Johanne Smith-Nielsen
Organization:
Study Overview
Official Title:
Attachment and Child Health (ATTACH) Added to Treatment As Usual Versus Treatment As Usual Alone for Parents With Psychosocial Problems: A Feasibility Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-09
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:
AiD
Brief Summary:
The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program "ATTACH(TM) increases mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center.
The main questions the trial aims to answer are:
* How many eligible parents agree to participate in the random allocation to treatment?
* How many parents allocated to receive "ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)?
* How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills?
* Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)?
Researchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark.
Participants will:
1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills.
2. Be randomly allocated to receive treatment in their local family center with or without ATTACH.
3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received.
4. After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.
The main questions the trial aims to answer are:
* How many eligible parents agree to participate in the random allocation to treatment?
* How many parents allocated to receive "ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)?
* How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills?
* Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)?
Researchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark.
Participants will:
1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills.
2. Be randomly allocated to receive treatment in their local family center with or without ATTACH.
3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received.
4. After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.
Detailed Description:
See the attached project protocol for a detailed description
Study Oversight
Has Oversight DMC:
False
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?: