Contact information
Type
Scientific
Primary contact
Prof Peter Fonagy
ORCID ID
Contact details
Sub-department of Clinical Health Psychology
University College London
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)20 7679 1943
p.fonagy@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RG/1/010104792
Study information
Scientific title
Helping parents with mental health problems to parent young infants: a Randomised Controlled Trial of Parent-Infant Psychotherapy and counselling
Acronym
PIP RCT
Study hypothesis
Current study hypotheses as of 24/10/2007:
Aim 1:
The first aim of the study is to demonstrate that Parent-Infant Psychotherapy (PIP), an intervention based on addressing issues of parent-infant relationships with the participation of the infant, is more beneficial to infant development and parent-infant relationship than services that are routinely available to parents with mental health problems and their babies.
Aim 2:
The second aim of the study is to demonstrate that PIP brings about changes in maternal mental state; particularly increasing maternal well-being to a degree that is comparable to interventions that are routinely available to this group.
Aim 3:
The third aim is to explore parents' experience of therapy in order to enlighten service providers about the aspects of these services that are valued by users. This part of the study is intended as a preliminary inquiry into the nature of the barriers that can prevent a significant proportion of mothers with psychological difficulties and relationship problems with their infants from approaching mental health services.
Aim 4:
Finally, the study intends to establish the background for attempts at testing hypotheses concerning the clinically most effective components of PIP.
Previous study hypotheses:
Aim 1:
The first aim of the study is to demonstrate that Parent-Infant Psychotherapy (PIP), an intervention based on addressing issues of parent-infant relationships with the participation of the infant, is more beneficial to infant development and parent-infant relationship than an intervention addressing the mothers mental health issues alone.
Aim 2:
The second aim of the study is to demonstrate that PIP brings about changes in maternal mental state; particularly increasing maternal well-being to a degree that is comparable to interventions specifically aimed at addressing maternal mental health problems alone.
Aim 3:
The third aim is to explore parents' experience of therapy (both PIP and counselling) in order to enlighten service providers about the aspects of these services that are valued by users. This part of the study is intended as a preliminary inquiry into the nature of the barriers that can prevent a significant proportion of mothers with psychological difficulties and relationship problems with their infants from approaching mental health services.
Aim 4:
Finally, the study intends to establish the background for attempts at testing hypotheses concerning the clinically most effective components of PIP.
Ethics approval
Camden and Islington Community Local Research Ethics Committee (REC), 25/05/2005, ref: 05/Q0511/47). As of 24/10/2007 a substantial amendment was made to the trial design, and this was approved by the above REC on the 11/06/2007.
Study design
Interventional study with random allocation to one of two treatment groups. Allocation is done by external advisor to the study. Longitudinal follow up at six and twelve months.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Probable psychiatric caseness as measured on the general health questionnaire
Intervention
Current interventions as of 24/10/2007:
1. Treatment As Usual (TAU): this will be the package of care that is normally available to families in their local area. In general, TAU is provided through primary care workers such as GPs and health visitors. Some more specialised services are often available for parents with mental health problems. These include support from family support workers, enhanced health visiting, social worker or midwifery services (listening visits), one to one support from clinical psychologists (provided through local Child and Adolescent Mental Health Services [CAMHS] services), psychotherapists or counsellors, postnatal support groups, creches providing respite, parenting education workshops, peer-supported groups, home visiting services, child psychiatry and family therapy. The level of input from each of these depends on the needs of the families and the local provision.
2. Parent-infant psychotherapy (experimental treatment): this treatment involves both mothers and infants attending the GP surgery or health centre or accessible community setting close to the GP practice. Clinicians involved in this treatment are psychotherapists with a psychodynamic orientation. The focus of the treatment is on the interactions between the parent and child during the session and how the parents understand their children's emotional needs as well as their own thoughts and feelings about their parenting role.
Simply stated, parent-infant psychotherapy focuses on the relationship through individual work with parent and with child and with the two of them together. These levels of work all occur with parent and child in the same room with one therapist. The aim is to help parents understand their children's development and emotional needs and in turn, to help children become more effective in engaging their parents' care and hence, to increase parents' pleasure in their parenting role. This is achieved by talking with the parent about their current experiences with the child, especially as observed during the sessions, and about parents' past childhood experiences as these will impact on their parenting of the particular child. The therapist also works directly with the child using age appropriate play in an effort to model effective behaviours for the parent and to help the child feel more engaged and emotionally cared for during the session. These direct efforts with the child are conceptually focused to make the parents' behaviours more predictable for the child, in an effort to facilitate more effective interactions between the two. The child's experience of this predictability is expressed through his/her more effective behaviours in engaging the parent's care-giving.
Conversely, parents are helped to develop more effective ways to engage the child that are contingently responsive in age appropriate ways to a child's emotional needs. In this intensive focus on the interactions between the two, we hope that both child and parent become more predictable to each other. This treatment is manualised with full descriptions of the early, middle and ending phase of the intervention and includes criteria for adherence. Therapists' performance is monitored through regular videotaping during training and therapists are trained to adhere to the criteria in the model. In the trial, videotaping of therapy sessions will only take place on specific random sessions.
The treatment takes place usually over a twenty-six week period (six months) with an average of 10 sessions total and an average of a session every two weeks.
Previous interventions:
1. Parental counselling (standard treatment): counsellors associated with general practices adhere to the standards of the British Association of Counselling and Psychotherapy and possess a counselling or psychotherapy qualification from a UK accrediting body. All are members of United Kingdom Council for Psychotherapy (UKCP) or British Confederation of Psychotherapists (BCP). The participating practices all have one or more counsellors working mostly on a part-time basis in the practice. Their orientation is psychodynamic or humanistic. These counselling sessions focus on mothers' presenting problems, past history and relationship difficulties including though not exclusive to those with their child. Importantly, during these sessions, the child is not present and the relationship between the mother and child is not the exclusive focus. On average, parents attend such counselling sessions over a six-month period with an average of 10 to 12 sessions. While these sessions are not taped or video recorded, counsellors routinely keep detailed process notes. This treatment is not manualised but counsellors will complete a process report checklist, the periodical rating scale. These ratings will be used to describe the therapists' standard mode of working with families and mothers' response to treatment.
2. Parent-infant psychotherapy (experimental treatment): this treatment involves both mothers and infants attending the GP surgery or health centre or accessible community setting close to the GP practice. Clinicians involved in this treatment are psychotherapists with a psychodynamic orientation. The focus of the treatment is on the interactions between the parent and child during the session and how the parents understand their children's emotional needs as well as their own thoughts and feelings about their parenting role.
Simply stated, parent-infant psychotherapy focuses on the relationship through individual work with parent and with child and with the two of them together. These levels of work all occur with parent and child in the same room with one therapist. The aim is to help parents understand their children's development and emotional needs and in turn, to help children become more effective in engaging their parents' care and hence, to increase parents' pleasure in their parenting role. This is achieved by talking with the parent about their current experiences with the child, especially as observed during the sessions, and about parents' past childhood experiences as these will impact on their parenting of the particular child. The therapist also works directly with the child using age appropriate play in an effort to model effective behaviours for the parent and to help the child feel more engaged and emotionally cared for during the session. These direct efforts with the child are conceptually focused to make the parents' behaviours more predictable for the child, in an effort to facilitate more effective interactions between the two. The child's experience of this predictability is expressed through his/her more effective behaviours in engaging the parent's care-giving.
Conversely, parents are helped to develop more effective ways to engage the child that are contingently responsive in age appropriate ways to a child's emotional needs. In this intensive focus on the interactions between the two, we hope that both child and parent become more predictable to each other. This treatment is manualised with full descriptions of the early, middle and ending phase of the intervention and includes criteria for adherence. Therapists' performance is monitored through regular videotaping during training and therapists are trained to adhere to the criteria in the model. In the trial, videotaping of therapy sessions will only take place on specific random sessions.
The treatment takes place usually over a twenty-six week period (six months) with an average of 10 sessions total and an average of a session every two weeks. As stated above, this is equivalent to the average dose or total session amount in the counselling intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Infant well-being, including developmental level and health status
Secondary outcome measures
1. Quality of the parent-child interaction
2. Maternal well-being, including mental health, parenting stress and life outcomes
3. Parental experience of the therapeutic intervention
Overall trial start date
25/05/2005
Overall trial end date
01/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Independently identified by their General Practitioner (GP), health visitor, or another professional as requiring counselling or other mental health services
2. The child is less than 12 months of age
3. Mothers meet probable psychiatric case criteria based on the general health questionnaire (greater than 4/5) (to be assessed by research team)
4. Mothers meet at least one of the following indicators of social exclusion:
4.1. Low income household (eligibility for income support)
4.2. Long term unemployment (greater than 2 years)
4.3. Temporary or overcrowded accommodation (more than two persons per room)
4.4. Single or unpartnered
4.5. Presence of chronic physical illness or disability
4.6. Early childhood history of foster or institutional care
4.7. Social isolation associated with recent relocation
4.8. Less than 20 years of age
4.9. Previous diagnosis of non-psychotic psychiatric illness
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 parent and infant dyads
Participant exclusion criteria
1. Non-English speaking families
2. Current psychosis
3. Substance abuse disorders or chronic drug dependence
4. Intelligence Quotient (IQ) below 70
5. Infants with any sensory or motor disability that prevents their participation in a standard developmental assessment (e.g. blindness, hearing impairment, cerebral palsy)
Recruitment start date
25/05/2005
Recruitment end date
01/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Department of Psychology
University College London
Gower street
London
WC1E 6BT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Big Lottery Fund (ref: RG/1/010104792)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26939716