Plain English Summary
Background and study aims
Research shows that the first two years of a child's life are important because the parent-infant relationship during this period influences many aspects of the child's early and later development. However, recent estimates show that maltreatment during infancy is common. Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant's physical and emotional needs. The poor outcomes that are associated with such drug-dependency appear to be linked to the multiple difficulties experienced by such parents (e.g. drug use, mental health problems, family relationships, socioeconomic factors, etc.). An increase in the understanding of the crucial importance of early relationships for infant wellbeing, has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent-infant interaction, particularly in families experiencing serious problems such as drug and alcohol dependency. The Parents under Pressure (PUP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby's development. The intervention is also aimed at helping families to address wider problems related to housing and social factors. An evaluation of the PuP programme in Australia found a significant reduction in a number of aspects of parental wellbeing including their drug dependency, and their children's emotional and behavioural adjustment. The aims of the proposed research are to evaluate the following:
1. The acceptability and feasibility of the delivery of the Parents under Pressure Programme in specialist drug and alcohol treatment centres across the UK;
2. The short and long-term effectiveness of the Parents under Pressure programme in supporting parents to manage their drug and/or alcohol misuse more effectively compared with parents who receive usual care only;
3. The cost-effectiveness of the Parents under Pressure Programme compared with usual services.
Who can participate?
The following families are eligible to participate in the study:
1. Families in which the primary caregiver is receiving either an opioid treatment programme or an alcohol abstinence/relapse prevention programme AND
2. They have a child under the age of two AND
3. They are able to communicate in English
What does taking part in the study involve?
Participants will be randomly allocated to one of two groups. One group will receive standard care, and the second group will receive the PuP service. Families allocated to the standard care group will receive the standard services that are available in each area. Families who are allocated to receive the PuP programme will receive visits for around 20 weeks from a PuP practitioner. Both groups will be visited by study researchers at three time points to ask them to complete a questionnaire, and to talk to them about the support they are receiving, and how they are getting on.
What are the possible benefits of taking part?
We hope that participation in the study will be an interesting and satisfying experience for all families, and that in the long-term, the study will produce an advance in knowledge about what works to help families who are experiencing problems.
Where is the study being run?
The study is being conducted in five NSPCC family centres across this UK. The research is being conducted by a team of researchers at Warwick Medical School, at the University of Warwick.
When is the study starting and how long is it expected to run for?
The study starts in January 2012. Recruitment will commence in March 2012 and continue for one year. Delivery of the assessment will be completed in October 2012. One year follow-up will be conducted from March 2013 through to March 2014. The study ends in December 2014.
Who is funding the study?
National Society for the Prevention of Cruelty to Children (NSPCC).
Who is the main contact?
Professor Jane Barlow
jane.barlow@warwick.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The evaluation of the Parents under Pressure Programme: a randomised controlled trial
Acronym
PuP
Study hypothesis
The PuP programme will be effective in reducing the potential of child abuse and improve the parent-infant relationship.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Methadone-maintained and alcohol-dependent parents
Intervention
The study will comprise a randomised controlled trial in which 140 families recruited from four drug / alcohol treatment centres will be randomly allocated to the intervention or standard treatment group.
The PuP programme has now been developed for use with parents of children less than 2 years of age. The program is home based and uses a Parent Workbook to frame the intervention. A focus on sensitivity to infant cues occurs in vivo with the therapist and mother working together to explore the infants emotional state, to increase maternal warmth and emotional connection that is genuine and spontaneous. Non hostility is also a focus with explicit links made between emotional regulation, feelings of frustration and beliefs about the infant¡¦s intentions. Use of technology as a therapeutic aid has been incorporated with mobile phones, photograph and video facilities, which allow the therapist to capture special moments to help mothers reflect on their own behaviour and that of their baby. Furthermore, mother, infant and PUP therapist engage in domestic and related activities that also provides the opportunity for further enhancement of maternal sensitivity and maternal emotional management. Shopping, collecting older children from school and managing other services such as housing, benefits (Centrelink) etc give ample opportunity for in vivo practise of emotional regulation. The intervention will last approximately 20 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Child Abuse Potential will be assessed using the Child Abuse Potential Inventory (CAP), which is a self-report questionnaire developed to identify individuals at risk for physical child abuse.
The instrument contains 160 items in an agree/disagree format. The CAP has three validity scales:
Lie, Random Response, and Inconsistency scales that are combined to derive three validity indices: Faking Good, Faking Bad, and Random Response.
The CAP Abuse scale consists of 77 items randomly distributed throughout the questionnaire. The internal reliability of the Abuse scale is high, with KR-20 correlation coefficients ranging from .92 to .96 and good temporal stability of .91 and .83 for 1-day and 1-month intervals, respectively.
Secondary outcome measures
1. Parent-child interaction will be assessed using the CARE index, which measures three aspects of maternal behaviour:
1.1. Sensitivity
1.2. Covert and overt hostility
1.3. Unresponsiveness)
and four aspects of infant behaviour:
1.4. Cooperativeness
1.5. Compulsive compliance
1.6. Difficultness
1.7. Passivity
These scales are highly correlated with the infant Strange Situation assessment pattern of attachment and also differentiate abusing from neglecting, abusing and neglecting, marginally maltreating, and adequate dyads. Scores range from 0 to 14, higher scores indicating better sensitivity and/or co-operation etc.
2. Parenting Stress will be measured using the Parenting Stress Index (PSI) Short Form (Abidin,1995), which is a well-validated measure of perceived stress in the parenting role. High scores on the PSI have been associated with abusive parenting with recent studies finding that parenting stress is higher in women with five or more risk factors for child abuse.
3. Infant social and emotional adjustment will be assessed using the Brief Infant and Toddler Socio-emotional Adjustment Scale which is a 42-item parent-report measure of infant-toddler (i.e. 1-3 year old children) social and emotional adjustment. It comprises two subscales competence and problems. The total for the problems subscale is produced by summing the scores across 31 items and the total for the competence subscale is produced by summing the scores across 11 items. A higher score for the competence subscale and a lower score for the problems subscale indicate better adjustment. and adequate internal consistency for the problem scale and the competence scale). It also discriminates children with clinically significant problems from matched subjects.
4. Parents object relations will be assessed using the Mothers Object Relations Scale-Short form, which is a 14-item screening tool for identifying potential areas of difficulty in the early mother-infant relationship in terms of the mothers working model of attachment by measuring maternal perceptions about:
4.1. Infants emotional warmth
4.2. Infants perceived invasiveness
This tool has been shown to possess stable and internally coherent scales.
5. Child emotional and behavioural problems will be assessed using the Strengths and Difficulties Questionnaire which is a widely used measure of child behaviour problems and has both a parent report and teacher/independent observer version that will be completed. It yields a total Problem Score as well as individual scales of Conduct Problems, Emotional Symptoms, Attention/concentration, Peer Problems.
6. Parental methadone dose will be confirmed by case records, Parental alcohol use, measured using the Timeline Followback (TLFB), which is a widely used calendar-based method of assessment. The interview is structured around a calendar in which recent events such as pay day, social events etc are used as memory aids to assist in recall. This is a reliable and valid measure of substance use. The number of days of substance use (including amphetamines, cannabis, alcohol and heroin) in the 30 days prior to assessment is recorded.
7. Incidence of child abuse will be assessed using social work records to assess the following outcomes: number of case conferences; children with Child Protection Plan in place; children removed from the home. Other outcomes will include attendance at A&E.
8. Therapist Adherance will be assessed using the PUP Therapist Adherence Measure (TAM). This measure was developed for use in the pilot study and lists the key concepts that are covered in the PUP program. It is based on the Therapist Adherence Measure developed for use in multi-systemic therapy which has found that high scores predictive of client outcome.
Overall trial start date
01/01/2012
Overall trial end date
01/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participation in an opioid replacement treatment programme or an alcohol abstinence / relapse prevention programme
2. At least one child under the age of 2 years
3. Parents with an ability to understand and read English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140 families
Participant exclusion criteria
1. Parents with severe learning disabilities
2. Unable to understand spoken English
Recruitment start date
01/03/2012
Recruitment end date
01/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
c/o Professor Jane Barlow
Warwick Medical School
Gibbet Hill
Coventry
CV4 7AL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
National Society for the Prevention of Cruelty to Children (NSPCC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23841920
Publication citations
-
Protocol
Barlow J, Sembi S, Gardner F, Macdonald G, Petrou S, Parsons H, Harnett P, Dawe S, An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness., Trials, 2013, 14, 210, doi: 10.1186/1745-6215-14-210.