Mother-child Relationship DisturbancesEarly Phase 1MIPPS-02NCT01087112
Mother-Infant Psychoanalysis Project of Stockholm (MIPPS)- Follow-up at 4½ Years
A Early Phase 1 study testing Mother-Infant Psychoanalytic tmt and Child Health Centre care in people with Mother-child Relationship Disturbances, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm 2005-2008. The infants were < 18 months at interview #1. Read more about this study
- Who is it for?
- Ages 54 to 54 months
- Conditions the study is for
- Mother-child Relationship Disturbances
- What is being tested?
- Mother-Infant Psychoanalytic tmt and Child Health Centre care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Jun 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 54 to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant's well-being, or the mother-baby relationship (this was operationalized as a score < 80 ("perturbed relation") on the PIR-GAS or, alternatively, > 2.5 on the SPSQ).
- Infant of any gender, age below 18 months.
- Duration of worries exceeding two weeks.
- Domicile in Stockholm.
- Reasonable mastery of Swedish.
Who cannot join
- Maternal psychosis according to DSM-IV, to an extent precluding collaboration.
- Substance dependence according to DSM-IV, to an extent precluding collaboration.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
Stockholm, 11641
Björn Salomonsson, Doct.student, +4686429998, bjorn.salomonsson@ki.se
Majlis Winberg Salomonsson, M.Sci.Psych.
About this study
Official title: A Follow-up Study of a Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment and Treatment As Usual at Child Health Centres
An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm 2005-2008. The infants were < 18 months at interview #1. At 6 months follow-ups, significant effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years; to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate results on children who now have reached an age where they can participate more actively in evaluations.
Read the detailed description
DESIGN
The 71 dyads remaining from the MIPPS-01 study will be interviewed when the children have reached 4½ years, in order to evaluate the long-term intervention effects of MIP treatments delivered by psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society and of the usual treatments of infants and children in Sweden implying contact with nurses at Child Health Centres.
INSTRUMENTS
Mother-report questionnaires; the Ages and Stages Questionnaire:Social-Emotional (ASQ:SE; Squires et al., 2002), the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987), the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997) and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).
Independently rated video-taped mother-child interactions: the Emotional Availability Scale (EAS; Biringen, 1998).
Assessment of the general functioning of the child : Children's Global Assessment Scale (Shaffer et al 1983).
Assessment of the child's cognitive functioning: Wechsler Preschool and Primary Scale of Intelligence (WPPSI, Wechsler, 2005).
Assessment of the child's social and emotional functioning: Story Stem Attachment Profile (SSAP, Hodges et al., 2003). Machover Draw-a-Person Test (Blomberg \& Cleve, 1997)
- Conditions
- Mother-child Relationship Disturbances
- Being tested
- Mother-Infant Psychoanalytic tmt, Child Health Centre care
- Keywords
- MIP, RCT, postnatal depression, Mother-child relationship
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-Infant Psychoanalytic tmtBehavioural
Also called MIP
Psychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly.
Child Health Centre careBehavioural
Also called CHCC
Nurse calls at Child Health Centres (CHC), with regular paediatric checkups. The nurse was encouraged to promote attachment and to detect postnatal depressions. Appointments with a psychiatrist or therapist or child psychiatric psychologist was initiated in 1/3 of the cases. This was registered at the end-point interview.
| Study group | Role | What they receive |
|---|---|---|
| Child Health Centre care | Active comparator | TAU involved scheduled health visitor calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The health visitor is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Additional treatment was initiated in 1/3 of the cases. This was registered at the end-point interview. Receives: Behavioral: Child Health Centre care |
| Mother-Infant Psychoanalytic tmt | Experimental | MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst takes great care in enrolling the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her all space needed to vent her own frustration, depression and anxiety. Receives: Behavioral: Mother-Infant Psychoanalytic tmt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child functioning: Children's Global Assessment Scale
Measured: At followup interview
Maternal depression: Edinburgh Postnatal Depression Scale
Measured: At followup interview
Secondary outcomes (7)
Maternal distress: Symptom Check List - 90
Measured: At followup interview
Maternal stress: Swedish Parental Stress Questionnaire
Measured: At followup interview
Child functioning: Ages and Stages Questionnaire:Social Emotional
Measured: At followup interview
Child functioning: Strengths and Difficulties Questionnaire
Measured: At followup interview
Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence
Measured: At followup interview
Child's social and emotional functioning: Story Stem Attachment Profile
Measured: At followup interview
Child's social and emotional functioning: Machover Draw-a-Person test
Measured: At followup interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-child Relationship DisturbancesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Björn Salomonsson, MD, Principal investigator, Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska InstitutetMajlis Winberg Salomonsson, M.Sci.Psych., Principal investigator, Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087112
- Sponsor's protocol ID
- MIPPS-02
- Acronym
- MIPPS-02
- Status last verified
- Dec 2009
- First submitted
- 29 Dec 2009
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study of a Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment and Treatment As Usual at Child Health Centres
- ClinicalTrials.gov ID
- NCT01087112
- Acronym / sponsor ID
- MIPPS-02 / MIPPS-02
- Conditions
- Mother-child Relationship Disturbances
- Keywords
- MIP, RCT, postnatal depression, Mother-child relationship
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 16 Mar 2010 (estimated)
- 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.
An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm 2005-2008. The infants were < 18 months at interview #1. At 6 months follow-ups, significant effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years; to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate results on children who now have reached an age where they can participate more actively in evaluations.
Detailed description
DESIGN
The 71 dyads remaining from the MIPPS-01 study will be interviewed when the children have reached 4½ years, in order to evaluate the long-term intervention effects of MIP treatments delivered by psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society and of the usual treatments of infants and children in Sweden implying contact with nurses at Child Health Centres.
INSTRUMENTS
Mother-report questionnaires; the Ages and Stages Questionnaire:Social-Emotional (ASQ:SE; Squires et al., 2002), the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987), the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997) and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).
Independently rated video-taped mother-child interactions: the Emotional Availability Scale (EAS; Biringen, 1998).
Assessment of the general functioning of the child : Children's Global Assessment Scale (Shaffer et al 1983).
Assessment of the child's cognitive functioning: Wechsler Preschool and Primary Scale of Intelligence (WPPSI, Wechsler, 2005).
Assessment of the child's social and emotional functioning: Story Stem Attachment Profile (SSAP, Hodges et al., 2003). Machover Draw-a-Person Test (Blomberg \& Cleve, 1997)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child Health Centre care | Active comparator | Behavioral: Child Health Centre careTAU involved scheduled health visitor calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The health visitor is encouraged to promote attachment and to detect postnatal depressions. Mothers may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Additional treatment was initiated in 1/3 of the cases. This was registered at the end-point interview. |
| Mother-Infant Psychoanalytic tmt | Experimental | Behavioral: Mother-Infant Psychoanalytic tmtMIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst takes great care in enrolling the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her all space needed to vent her own frustration, depression and anxiety. |
Who may qualify
- Ages
- 54 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant's well-being, or the mother-baby relationship (this was operationalized as a score < 80 ("perturbed relation") on the PIR-GAS or, alternatively, > 2.5 on the SPSQ).
- Infant of any gender, age below 18 months.
- Duration of worries exceeding two weeks.
- Domicile in Stockholm.
- Reasonable mastery of Swedish.
Key exclusion criteria (2 listed)
- Maternal psychosis according to DSM-IV, to an extent precluding collaboration.
- Substance dependence according to DSM-IV, to an extent precluding collaboration.
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 |
|---|---|---|
| Mother-Infant Psychoanalytic tmtAlso: MIPPsychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly. | Behavioural | Mother-Infant Psychoanalytic tmt |
| Child Health Centre careAlso: CHCCNurse calls at Child Health Centres (CHC), with regular paediatric checkups. The nurse was encouraged to promote attachment and to detect postnatal depressions. Appointments with a psychiatrist or therapist or child psychiatric psychologist was initiated in 1/3 of the cases. This was registered at the end-point interview. | Behavioural | Child Health Centre care |
Primary outcome
Child functioning: Children's Global Assessment Scale
Time frame: At followup interview
Maternal depression: Edinburgh Postnatal Depression Scale
Time frame: At followup interview
7 secondary outcomes
Maternal distress: Symptom Check List - 90
Time frame: At followup interview
Maternal stress: Swedish Parental Stress Questionnaire
Time frame: At followup interview
Child functioning: Ages and Stages Questionnaire:Social Emotional
Time frame: At followup interview
Child functioning: Strengths and Difficulties Questionnaire
Time frame: At followup interview
Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence
Time frame: At followup interview
Child's social and emotional functioning: Story Stem Attachment Profile
Time frame: At followup interview
Child's social and emotional functioning: Machover Draw-a-Person test
Time frame: At followup interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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. This study is not recruiting at the moment.
Björn Salomonsson, MD principal investigator
Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
Majlis Winberg Salomonsson, M.Sci.Psych. principal investigator
Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mother-Infant Psychoanalytic tmt and Child Health Centre care in people with Mother-child Relationship Disturbances, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Mar 2010. 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 Sweden. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per-Anders Rydelius, Professor (++46851777205, per-anders.rydelius@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child functioning: Children's Global Assessment Scale (time frame: At followup interview). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2010; AzTrials last refreshed its copy on 8 Nov 2026.